Item | Information |
---|---|
CAS RN | 3811-73-2 |
Chemical Name | 2-Pyridinethiol, 1-oxide, sodium salt |
Substance ID | m-nite-3811-73-2_v1 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Sample SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (N-oxides) present in the molecule, and the oxygen balance is -118, higher than the criteria: -200, but the classification is not possible due to no data. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (N-oxides) present in the molecule, but the classification is not possible due to no data. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (Not applicable) |
- |
- | - | It contains a metal (Na), but it is estimated that it does not react vigorously with water from measured data: water solubility of 646.6 g/L (GESTIS (Accessed June 2020)). | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
14 | Oxidizing solids | Classification not possible |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to elements other than carbon or hydrogen (N, Na). However, the classification is not possible due to no data. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
17 | Desensitized explosives | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (N-oxides) present in the molecule, and the oxygen balance is -118, higher than the criteria: -200, but the classification is not possible due to no data. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 4 |
Warning |
H302 | P301+P312 P264 P270 P330 P501 |
[Rationale for the Classification] It was classified in Category 4 from (1) - (5). [Evidence Data] (1) LD50 for rats: 1000-2000 mg/kg (DFG MAK (2019)) (2) LD50 for rats (females): 1208 mg/kg (DFG MAK (2019), NICNAS IMAP (2017)) (3) LD50 for rats: 660-900 mg/kg (NICNAS IMAP (2017)) (4) LD50 for rats: 980-1120 mg/kg (NICNAS IMAP (2017)) (5) LD50 for rats: 1500 mg/kg (NICNAS IMAP (2017)) |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
1 | Acute toxicity (Dermal) | Category 4 |
Warning |
H312 | P302+P352 P362+P364 P280 P312 P321 P501 |
[Rationale for the Classification] It corresponds to "Not classified" for rats from (1) and (2) and Category 4 for rabbits from (3). Therefore, the category with higher hazard was adopted, and it was classified in Category 4. [Evidence Data] (1) LD50 for rats: > 2000 mg/kg (NICNAS IMAP (2017)) (2) LD50 for rats: 2500 mg/kg (NICNAS IMAP (2017)) (3) LD50 for rabbits: 1800 mg/kg (NICNAS IMAP (2017)) |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified." |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Category 3 |
Danger |
H331 | P304+P340 P403+P233 P261 P271 P311 P321 P405 P501 |
[Rationale for the Classification] It was classified in Category 3 from (1). Besides, (1) was adopted for classification by prioritizing a test conducted according to OECD TG403 (GLP-compliant). [Evidence Data] (1) LC50 for rats (4 hours) (OECD TG403, GLP): between 0.5-1.0 mg/L (EU CLH report (2019)) [Reference Data, etc.] (2) LC50 for rats (males) (4 hours): 1.3 mg/L (NICNAS IMAP (2017), DFG MAK (2019)) (3) LC50 for rats (females) (4 hours): 0.8 mg/L (NICNAS IMAP (2017), DFG MAK (2019)) |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 | P302+P352 P332+P313 P362+P364 P264 P280 P321 |
[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 14-day observation), severe edema was seen (erythema/eschar score: 0/3.3/2.3, edema score: 0/4/1) (CLH report (2019), DFG MAK (2019), NICNAS IMAP (2017), REACH registration dossier (Accessed May 2020)). (2) It is reported that one drop of an aqueous solution of this substance at 1-2% on the cheek, neck, or back of hand skin for healthy volunteers produced reversible reactions (burning sensation, erythema) in 10-60% of subjects (NICNAS IMAP (2017)). [Reference Data, etc.] (3) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 72-hour observation), slight skin irritation was found (erythema/eschar score: 1/1/1, edema score: 0.3/0.3/0.3) (CLH report (2019), REACH registration dossier (Accessed May 2020)). (4) It is reported that in a skin irritation test with rabbits (n = 6) (OECD TG 404, GLP, 4-hour application, 72-hour observation), slight skin irritation was observed (erythema/eschar score: 0.7/0.7/0/0.3/0.7/1.7, edema score: 0/0/0/0/0.3/0.7) (CLH report (2019)). (5) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, 4-hour application, 72-hour observation), slight skin irritation was seen (erythema/eschar score: 0/0.3/0.3, edema score: 0/0/0.3) (CLH report (2019)). (6) It is reported that in an in-vitro skin irritation test (OECD TG 439, GLP), cell viability, R = 114% (CLH report (2019)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
3 | Serious eye damage/eye irritation | Category 2 |
Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
[Rationale for the Classification] It was classified in Category 2 from (1). Besides, (2) - (7) suggest that it corresponds to "Not classified," but because dead animals were reported in (1) as well as (2) and (3), it was decided to classify it in Category 2 from the viewpoint of protecting workers. [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 6) (OECD TG 405, GLP, 14-day observation), three animals died on Day 2, and reversible iritis and reversible conjunctival irritation were observed in all the six animals (corneal opacity score: -/0/0/0/0/0, iritis score: -/0/0/1/0/0, conjunctival redness score: -/2/3/2/1.7/2, chemosis score: -/0/0.3/1/0.3/0.7) (CLH report (2019), NICNAS IMAP (2017)). [Reference Data, etc.] (2) It is reported that in an eye irritation test with rabbits (n = 6) (EPA OPP 81-4), four animals died within 24 hours. Corneal opacity was not observed in any animal at 1 hour or for the duration of the test in the surviving animals. Iritis was found in 4/6 at 1 hour (average score: 1) but was reversed in one surviving animal that was affected by 24 hours. Conjunctival lesions were seen in males for up to 72 hours (average 24/48/72-hour score: 1.67 each for erythema and edema) and females for up to 24 hours (average 24/48/72-hour score: 1). There were no ocular effects observed on Day 7 in the surviving animals (CLH report (2019), NICNAS IMAP (2017)). (3) It is reported that in an eye irritation test with rabbits (n = 6) (OECD TG 405, GLP, 72-hour observation), two animals died on Day 2, and reversible corneal opacity in one, reversible iritis in two, and reversible conjunctival irritation in all the animals were observed (corneal opacity score: 0/0.3/0/0/0/0, iritis score: 1/0/0/1/0/0, conjunctival redness score: 2/0/0/1/0/0.3, chemosis score: 1/0/0/0/0/0) (CLH report (2019), NICNAS IMAP (2017)). (4) It is reported that in an eye irritation test with monkeys (n = 3) (EPA OPP 81-4, GLP, 7-day observation), conjunctiva irritation was noted in two animals but was reversible within 7 days (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 1/1.3/0, chemosis score: 0/0/0) (CLH report (2019), NICNAS IMAP (2017)). (5) It is reported that in an eye irritation test with rabbits (n = 3) (OECD TG 405, GLP, 7-day observation), conjunctiva irritation was found in three animals but was reversed within 7 days (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 1.7/1.7/1.7, chemosis score: 1/0.7/0.3) (CLH report (2019)). (6) It is reported that in an eye irritation test with rabbits (n = 3) (OECD TG 405, GLP, 7-day observation), conjunctiva irritation was seen in three animals but was reversed within 2 days (corneal opacity score: 0/0/0/, iritis score: 0/0/0, conjunctival redness score: 0/0.3/0.3, chemosis score: 0/0/0) (CLH report (2019)). (7) It is reported that in vitro irritation score (IVIS) = 0.8 in an in-vitro eye irritation test (OECD TG 437) (CLH report (2019)). (8) Category 2 was proposed based on (1) in EU CLH (CLH report (2019)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
4 | Skin sensitization | Category 1 |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] It was classified in Category 1 from (1), (2). Besides, (2) suggests Category 1A, and (1) suggests Category 1B, but because the SI value was missing for the maximum concentration (25%) due to an error during handling cells in (2), it was judged that available data did not consist of sufficient information to enable sub-categorization. [Evidence Data] (1) It is reported that in a local lymph node assay (LLNA) with mice (n = 5) (OECD TG 429, GLP), irritation index (SI values) was 1.0 (5%), 1.8 (10%), 2.5 (15%), 7.2 (25%), and the EC3 value was calculated as 16% (CLH Report (2019)). (2) It is reported that in a local lymph node assay (LLNA) with mice (n = 4) (similar to OECD TG 429, GLP), irritation index (SI values) was 1.6 (0.25%), 4.6 (2.5%), and the EC3 value was calculated as 1.3% (CLH Report (2019)). [Reference Data, etc.] (3) It is reported that no sensitization reactions to a 1% solution of this substance were seen in patch test in workers 230 metal industry workers with dermatitis on their hands or forearms (DFG MAK (1998), NICNAS IMAP (2017)). (4) It is reported that one female worker who had been working in the metal industry for 10 years had clearly positive results 48, 72, and 96 hours after a patch test with a 0.3% solution of this substance, but patch tests carried out on volunteers (10) with the same solution yielded negative results (DFG MAK (1998), NICNAS IMAP (2017)). (5) It is reported that a 1% solution of this substance was applied to 100 healthy male persons in a patch test (upper arm, occlusive, 24-hour application, 15 applications during 30 days, induction) followed by challenge 2 weeks later (0.5% solution, occlusive, 24 hours), and no sensitization reactions were seen after removing the patch and 24 and 48 hours later (DFG MAK (1998), NICNAS IMAP (2017)). (6) It is reported that in patch tests carried out on 115 workers with dermatitis on the hands after handling metal-working fluids (0.1% solution of this substance, occlusive, 48-hour application), no sensitization reactions were found after 48 and 96 hours (DFG MAK (1998), NICNAS IMAP (2017)). (7) It is reported that in a maximization test with guinea pigs (n = 20) (intradermal administration: 5% solution), four animals died after topical induction, a positive rate was 0% for both 24 and 48 hours after the end of the challenge (test group 0/16 vs control group 1/10 (minimal erythema)) (DFG MAK (1998)). (8) It is reported that in a maximization test with guinea pigs, no sensitization was observed at up to the dose level where skin irritation was seen (EPA Pesticide RED (1995)). (9) It is reported that in a maximization test with guinea pigs (n = 10) (OECD TG 406), slight to severe erythema was found during the induction phase, and a positive rate was 20% (2/10) and 30% (3/10) 24 and 48 hours after challenge, respectively (CLH Report (2019), DFG MAK (1998), NICNAS IMAP (2017)). (10) In EU CLH, (2) suggests Category 1A, but because there was insufficient information to support the low EC3 value, Category 1 was proposed (CLH Report (2019)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus assay using bone marrow from mice (exposed once by oral gavage) and another micronucleus assay using bone marrow from mice (exposed once by intraperitoneal injection), negative results were reported respectively (NICNAS IMAP (2017)). (2) In bacterial reverse mutation assays, negative results were reported (NICNAS IMAP (2017)). (3) In a mammalian cell gene mutation assay, negative results were reported (NICNAS IMAP (2017)). (4) In a mammalian cell chromosome aberration assay, positive results were reported (NICNAS IMAP (2017)). (5) In an in vitro UDS assay using primary rat hepatocytes, negative results were reported (NICNAS IMAP (2017)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
6 | Carcinogenicity | Not classified |
- |
- | - | [Classification Results] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a combined chronic toxicity/carcinogenicity study (OECD TG 453, GLP) with SD rats dosed by gavage for 104 weeks, systemic toxicity (including skeletal muscle wastage, sciatic nerve and retinal atrophy, and spinal cord degeneration) was observed at or above 1.5 mg/kg, but there were no treatment related neoplastic changes up to the highest dose group (EU CLH Report (2019), NICNAS IMAP (2017), DFG MAK (2019)). (2) It was reported that in a combined chronic toxicity/carcinogenicity study (OECD TG 453, GLP) with SD rats dosed by gavage for 104 weeks, systemic toxicity (including skeletal muscle and nerve degeneration) was observed at or above 1.4 mg/kg, but there were no treatment related neoplastic changes up to the highest dose group (EU CLH Report (2019), NICNAS IMAP (2017), DFG MAK (2019)). (3) It was reported that in a carcinogenicity study (OECD TG 451, GLP) using a dermal route of exposure with CD-1 mice for 80 weeks, there was an increased incidence in epidermal hyperplasia at 40 mg/kg, but there were no treatment related neoplastic changes up to the highest dose group (EU CLH Report (2019), NICNAS IMAP (2017), DFG MAK (2019)). [Reference Data, etc.] (4) In EU CLP, it was classified as "Not classified." |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
7 | Reproductive toxicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a two-generation reproductive toxicity study with rats dosed by gavage (40.8% purity) (for 10 weeks prior to mating and until one day prior to study termination), increases in uterus weight and decreases in kidney weight (females) were observed in the F0 and F1 parent animals (females) exposed at or above 1.4 mg/kg/day, and a decrease in pup body weight and undescended testes were observed in the F2 pups (EU CLH Report (2019), NICNAS IMAP (2017), REACH registration dossier (Accessed May 2020)). It was reported that toxicological relevance to the reduced fertility of the F0 parent animals could not be assessed because there were no effects on sperm parameters (DFG MAK (2019)). (2) It was reported that in a two-generation reproductive toxicity study with rats dosed by gavage (for 11 weeks prior to mating and up to 25 days post partum), decreased body weight gain, hindlimb muscle atrophy, an increase in time to mating, and a decrease in the number of mating and fertile rats were observed in the F0 parent animals exposed at 3.5 mg/kg, and there were non-significant decreases in the number of pups born, non-significant delays in reaching developmental milestones, decreased body weight gain and hindlimb muscle atrophy in the F1 pups exposed at 3.5 mg/kg (EU CLH Report (2019), NICNAS IMAP (2017)). (3) It was reported that in a developmental toxicity study with rats dosed by gavage (OECD TG414, GLP, gestation day 6 to 19), there were reduced body weight, reduced food intake, impaired mobility, emaciation and reduced uterine weights were observed in parent animals exposed at 4 mg/kg/day, but only slight effects (lower fetal body weight and delayed ossification) were observed in pups (EU CLH Report (2019), NICNAS IMAP (2017)). (4) It was reported that in a developmental toxicity study with rabbits dosed by gavage (gestation days 6 to 19), no developmental toxicity was observed at 5 mg/kg/day (EU CLH Report (2019), NICNAS IMAP (2017)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] Based on (1) and (3), tremors and hindlimb impairment were obsesrved, and it was classified in Category 1 (nervous system). Some signs in (1) to (3) (such as lethargy, salivation and pupil dilation) were also considered to be supportive evidence for the classification. Furthermore, the LC50 value in (3) was considered to fall within the range of Category 1, and it was classified in Category 1 (nervous system). [Evidence Data] (1) It was reported that in multiple acute oral administration tests with rats, sub-lethal effects including ataxia, hunching, lethargy, tremors, salivation, lacrimation, diarrhea, altered muscle tone, piloerection and labored breathing were observed (NICNAS IMAP (2017)). (2) It was reported that in multiple acute dermal exposure tests with rats, sub-lethal effects including lethargy, nasal discharge, bloating, diarrhea, ptosis and pupil dilation were observed (NICNAS IMAP (2017)). (3) It was reported that in multiple acute inhalation toxicity studies (mist) with rats, sub-lethal effects including salivation, staining of the face, abdomen and genital areas, hindlimb impairment, prostration, lethargy, piloerection, chromodacryorrhea, ptosis, tremors, abnormal gait and maculate erythema were observed, and the LC50 value (4 hours) of females was 0.5 to 1.0 mg/L (EU CLH Report (2019), DFG MAK (2019)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1), (2), (4) and (5), neurotoxicity and resulting muscle atrophy were observed in rats exposed at the doses in Category 1 using oral, dermal and/or inhalation routes. Therefore, it was classified in Category 1 (nervous system). The slight hematological effects observed in (2) and (3) were not adopted for the classification of target organ toxicity. [Evidence Data] (1) In a 90-day oral administration study with rats dosed by gavage, atrophy of upper hindlimb muscles was observed in rats exposed at or above 2 mg/kg/day (within the range for Category 1), and hindlimb ataxia progressing to paralysis was observed in rats exposed at 8 mg/kg/day (within the range for Category 1), which were therefore euthanized moribund. It was reported that the hindlimb skeletal muscle atrophy which occurred in this test was considered to be neurogenic atrophy and that the NOEL at which no neurotoxicity occurred was 0.5 mg/kg/day (NICNAS IMAP (2017), EPA Pesticide RED (1995)). (2) It was reported that in two-year oral administration studies with rats dosed by gavage, there were hematological effects (decreases in red blood cell count/Hb/Ht) and an increase in CPK at or above 0.5 mg/kg/day (within the range for Category 1); hindlimb muscle atrophy in males at or above 1.5 mg/kg/day (within the range for Category 1); and hindlimb muscle atrophy, atrophy of nerve fibers in the spinal cord, hindlimb weakness, sciatic nerve degeneration and retinal atrophy in males and females at or above 3.5 mg/kg/day (within the range for Category 1) (EU CLH Report (2019), DFG MAK (2019), NICNAS IMAP (2017)). (3) It was reported that in a 52-week oral administration study with cynomolgus monkeys dosed by gavage, hematological effects were observed: a decrease in erythrocytes at or above 5 mg/kg/day (within the range for Category 1) and decreases in Hb/Ht in males and females exposed at 25 mg/kg/day (within the range for Category 2). No effects were noted on nerve/skeletal muscle in males dosed at up to 150 mg/kg/day and in females dosed at up to 75 mg/kg/day (EU CLH Report (2019), DFG MAK (2019)). (4) In a 90-day dermal administration study (6 hours/day) with rats, gross muscle wastage was observed in the 50 mg/kg/day group (within the range for Category 2) (in females in the 15 mg/kg/day and above group (within the range for Category 1)) and by histopathologic examination, upper hindlimb muscle and subcutaneous panniculus muscle atrophy were noted in the 50 mg/kg/day group, and to a lesser extent also in the 15 mg/kg/day group. In females in the 50 mg/kg/day group, sciatic nerve degeneration of individual fibers within the nerve trunk was reported (NICNAS IMAP (2017)). (5) In a 90-day inhalation exposure study (6 hours/day, 5 days/week) with rats, in the high dose group, the dose was initially 3.8 mg/m3 (0.004 mg/L) and was increased to 8.1 mg/m3 (0.008 mg/L) after 6 weeks. As a result, it was reported that no adverse effects were observed in males, while reduced body weight gain, impaired hindlimb function and muscle degeneration were observed in females (NICNAS IMAP (2017)). [Reference Data, etc.] (6) In 9 male workers involved in the production of this chemical for 2 to 13 years, no signs of toxicity were reported (NICNAS IMAP (2017)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Category 1 |
Warning |
H400 | P273 P391 P501 |
It was classified in Category 1 from 96-hour LC50 = 0.00767 mg/L for fish (Danio rerio) (EU CLP CLH, 2019). | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 2 |
- |
H411 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 because it was rapidly degradable (a degradation rate by carbon dioxide evolution: 73% (CLH Report, 2019)) and due to 72-hour NOEC = 0.033 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it was rapidly degradable (a degradation rate by carbon dioxide evolution: 73% (CLH Report, 2019)) and due to a low bioaccumulation estimate (log Kow = 0.002 (REACH registration dossier, 2021)), despite 96-hour LC50 = 0.00767 mg/L for fish (Danio rerio) (EU CLP CLH, 2019). By drawing a comparison between the above results, it was classified in Category 2. |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. | FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
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