Item | Information |
---|---|
CAS RN | 1071-93-8 |
Chemical Name | Hexanedioic acid, 1,6-dihydrazide |
Substance ID | m-nite-1071-93-8_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) | |
Sample SDS by MHLW (External link) | |
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 (hydrazines) 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)) |
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. Besides, there is information that it is combustible (GESTIS (accessed 2020)). | 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 (hydrazines) 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) |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). | 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 | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. | 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 |
- |
- | - | Classification is not possible because 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 (hydrazines) 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)) |
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) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats (females): > 2,000 mg/kg (OECD TG 423) (REACH registration dossier (Accessed Aug. 2020)) |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
1 | Acute toxicity (Dermal) | 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: 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) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 5.3 mg/L (REACH registration dossier (Accessed Aug. 2020)) |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [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, 72-hour observation), no skin irritation was seen (erythema/eschar score: 0/0/0, edema score: 0/0/0) (REACH registration dossier (Accessed Aug. 2020)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 3) (OECD TG 405, GLP, 72-hour observation), no eye irritation was seen (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0/0/0, chemosis score: 0/0/0) (REACH registration dossier (Accessed Aug. 2020)). |
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 1B |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] It was classified in Category 1B from (1), (2). As for mouse tests, knowledge contradicting to (1) was observed in (3), (4), but by considering the results of a test in guinea pigs (2), it was classified in Category 1B. [Evidence Data] (1) It is reported that in a local lymph node assay (LLNA) with mice (n = 4/group) (OECD TG 429, GLP), stimulation index (SI values) was 4.2 (5%), 9.1 (10%), 9.9 (25%) (REACH registration dossier (Accessed Aug. 2020)). (2) It is reported that in a maximization test with guinea pigs (n = 10/group) (OECD TG 406, intradermal administration: a 25% or 50% solution), a positive rate was all 100% (10/10) after 24, 48, 72 hours in both group administered a 25% and 50% solution (REACH registration dossier (Accessed Aug. 2020)). [Reference Data, etc.] (3) It is reported that in a local lymph node assay (LLNA) with mice (n = 5/group) (OECD TG 429, GLP), stimulation index (SI values) was 0.9 (0.25%), 1.0 (0.5%), 1.6 (1.6%) (REACH registration dossier (Accessed Aug. 2020)). (4) It is reported that in a local lymph node assay (LLNA) with mice (n = 5/group) (OECD TG 429, GLP), stimulation index (SI values) was 1.24 (2.5%), 1.48 (5%), 1.20 (10%) (REACH registration dossier (Accessed Aug. 2020)). |
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 (6), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using mice (OECD TG 474), negative results (oral administration and intraperitoneal administration) were reported (EFSA (2015)). (2) In a bacterial reverse mutation test (OECD TG 471), negative results were reported (JECDB (Accessed on May 2020), EFSA (2015), REACH registration dossier (Accessed on May 2020)). (3) In a chromosomal aberration test using the human lymphocytes (OECD TG 473), negative results were reported (REACH registration dossier (Accessed on May 2020)). (4) In an in vitro mammalian cell chromosome aberration test (OECD TG 473), negative results were reported (JECDB (Accessed on May 2020)). (5) In an in vitro mammalian cell gene mutation test (OECD TG 476), negative results were reported (REACH registration dossier (Accessed on May 2020)). (6) In a mouse lymphoma assay, negative results were reported (EFSA (2015)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
6 | Carcinogenicity | 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)) |
7 | Reproductive toxicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, for 42 days including two weeks prior to mating (males), for 42 to 58 days including two weeks prior to mating and until day 4 of lactation (females)), at 300 mg/kg/day, emaciation, urinary incontinence, diarrhea (one case of infertility), lower hemoglobin/MCHC levels, and a tendency of an increase in the number of dams whose one or more newborns died during the lactation period were observed in parental animals, while no significant changes in the number of live pups and viability index on day 4 were observed in pups (Safety Study Report (Ministry of Economy, Trade and Industry (METI), 2011)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (OECD TG414, gestation days 6 to 20), at 300 mg/kg/day, 1/22 females died and reduced body weight gain and reduced food consumption were observed in parental animals, while only lower body weights were observed in pups (REACH registration dossier (Accessed Aug. 2020)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route and inhalation route. However, there was not sufficient information available for classification in the dermal route. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats dosed by gavage (OECD TG423, GLP), no effects were observed at 2,000 mg/kg (upper limit of Category 2) (REACH registration dossier (Accessed Aug. 2020)). (2) It was reported that in a (dust) inhalation exposure test with rats (for 4 hours), no effects were observed at 5.3 mg/L (in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)). |
FY2020 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route. However, there was not sufficient information available for classification in the other routes. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by gavage (OECD TG408, GLP), no effects were observed at 100 mg/kg/day (upper limit of Category 2), but liver effects (increased weight, single cell necrosis, increased ALT, AST, ALP levels) were observed at and above 300 mg/kg/day (in the range corresponding to "Not classified") and hematological effects (decreased hemoglobin/hematocrit levels, increased ratio of RDW, reduced MCV/MCH (females), reduced red blood cell counts (males)), liver effects (higher total bilirubin levels), effects on the brain and sciatic nerve, a decrease in body weight and a slight reduction in food consumption (males) were observed at 1,000 mg/kg/day (in the range corresponding to "Not classified") (REACH registration dossier (Accessed Aug. 2020)). (2) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, GLP), emaciation, incontinence of urine, diarrhea/loose stool (one male of the recovery test group and one female of the treated group) and decreased hemoglobin and MCHC (females) were observed at 300 mg/kg/day (converted guidance value: 140 mg/kg/day, in the range corresponding to "Not classified") (Safety Study Report (Ministry of Economy, Trade and Industry (METI), 2011)). |
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 2 |
- |
H401 | P273 P501 |
It was classified in Category 2 from 72-hour EC50 = 8.7 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021). | 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 not rapidly degradable (not readily degradable, a 28-day degradation rate by BOD: 1% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2001)) and due to 72-hour NOErC = 0.22 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 not rapidly degradable (not readily degradable, a degradation rate by BOD: 1% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2001)) and due to 96-hour LC50 > 100 mg/L for fish (Cyprinus carpio) (REACH registration dossier, 2021). 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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