Item | Information |
---|---|
CAS RN | 57966-95-7 |
Chemical Name | 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; cymoxanil |
Substance ID | m-nite-57966-95-7_v2 |
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 |
- |
- | - | The molecule contains chemical groups (N-O) associated with explosive properties; its oxygen balance is -129.2, which is higher than -200. Classification is not possible due to lack of data. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | The molecule contains chemical groups (N-O) associated with explosive properties. Classification is not possible due to lack of data. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
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). | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
14 | Oxidizing solids | Classification not possible |
- |
- | - | It contains an oxygen atom that is bonded to a nitrogen atom. Classification not possible due to lack of data. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Containing no bivalent -O-O- structure in the molecule | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
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 |
Based on its rat LD50 values of approximately 1000 mg/kg (IUCLID (2000)) and 1100 mg/kg (HSDB (2000)), the substance was classified into Category 4. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on its rabbit LD50 values of > 2000 mg/kg (IUCLID (2000)) and > 3 g/kg (HSDB (2000)), the substance was classified into "Not classified" using the JIS classification criteria (Category 5 or "Not classified" category in the United Nations classification). | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | Since its rat LC50 is > 5mg/L (4 hours) (IUCLID (2000)), the substance was classified into "Not classified" using the JIS classification criteria (Category 5 or "Not classified" category in the United Nations classification). Because its saturated vapour concentration is 1.17*10^-5 mg/L, the study was presumably conducted in dust. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | Rabbit tests (Directive 84/449/EEC) found that the substance is not irritating (IUCLID (2000)). Thus, it was classified into "Not classified". | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | Rabbit tests (Directive 84/449/EEC) found that the substance is not irritating (IUCLID (2000)). Thus, it was classified into "Not classified". | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
4 | Skin sensitization | Category 1A |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1A. Also, based on the new evaluation, the classification result was changed. [Evidence Data] (1) According to the OECD TG 406, the concentration used for intradermal induction should be the highest to cause mild-to-moderate skin irritation and for the challenge exposure should be the highest non-irritant dose. The concentrations used for intradermal induction and challenge (25%) in the studies of (3) and (4) were too low because no signs of skin irritation were observed in any of the animals in a preliminary test. Therefore, the reliability of the negative results obtained is questionable. No signs of skin irritation were induced even by 40% concentration used in a preliminary test of the study of (2), but in the main test, following intradermal induction with 40% concentration and challenge with 20% concentration, 90% animals showed slight to moderate erythema and slight to well-defined edema and necrosis was additionally observed in 3 animals exposed to 40% concentration. From the above, the study of (2) was considered as the most reliable assay in assessing skin sensitization. Based on that, it was proposed in the CLH Report that this substance should be classified in Skin Sens. 1A (CLH Report (2021)). (2) It was reported that, in a Maximization test (OECD TG 406, GLP, intradermal injection: 1% solution) with guinea pigs (n=10), the positive rate at 24, 48, and 72 hours after the challenge was 100% (10/10 animals) at both of the challenge concentrations of 20% and 40% (ECHA RAC Opinion (2012), CLH Report (2011)). [Reference Data, etc.] (3) It was reported that, in a Maximization test (OECD TG 406, GLP, intradermal injection: 3% solution) with guinea pigs (n=20), the positive rate was 0% (both 24 and 48 hours after the challenge (ECHA RAC Opinion (2012), CLH Report (2011)). (4) It was reported that, in a Maximization test (OECD TG 406, GLP, intradermal injection: 1% solution) with guinea pigs (n=10), the positive rate was 0% (both 24 and 48 hours after the challenge (ECHA RAC Opinion (2012), CLH Report (2011)). (5) The results of the two studies of (3) and (4) indicated no skin sensitizing effects of this substance. However, in the study of (2), in all test animals, dermal reactions (slight to moderate erythema and slight to well defined edema) were observed after challenge. No differences between the studies could be identified that could explain the contradictory results. Based on these results, the possibility of skin sensitization cannot be excluded (ECHA RAC Opinion (2012)). |
FY2021 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | Based on negative results documented in in vivo mutagenicity tests using somatic cells (micronucleus tests using mouse bone marrow cells (OECD Guidelines 474)) (IUCLID (2000)), the substance was classified into "Not classified". Regarding in vitro tests, Ames tests gave negative results while chromosomal aberration tests yielded positive results (IUCLID (2000)). | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
6 | Carcinogenicity | Not classified |
- |
- | - | In 23-month mixed diet administration tests using rats (OECD Guidelines 453), abnormalities in intestines, lymph nodes and lungs were detected in pathological examinations, but they were not carcinogenic. In addition, in 18-month mixed diet administration tests using mice (OECD Guidelines 451), abnormalities in the testes, liver and digestive tract were detected, but they were not carcinogenic (IUCLID (2000)). Based on these reports, the substance was classified into "Not classified". | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] In the reproduction toxicity studies in (1) to (3), at the doses at which general toxicity effects appeared in parental animals, effects on sexual function and fertility (such as reduced luteinization and reduced numbers of corpora lutea and implantations, increased post-implantation losses) in female parent animals and reduced viability in pups were observed. In the developmental toxicity studies with rats in (4) and (5), at the doses at which toxicity effects appeared in dams, skeletal variations and visceral variations were observed in fetuses but no apparent teratogenicity was observed. In the developmental toxicity studies with rabbits in (6) to (8), it was reported that, at the doses at which general toxicity effects appeared in dams, cleft palate in (6) and skeletal malformations in (8) occurred although with low frequency. From the above, since concerns about reproductive effects and teratogenesis were indicated at the doses at which slight general toxicity effects were observed in dams, it was classified in Category 1B. It was classified based on the new information source. [Evidence Data] (1) It was reported that, in a two-generation reproduction toxicity study with rats dosed by feeding (100 to 1,500 ppm), at the high dose (1,500 ppm) at which marked general toxicity effects in P and F1 parental animals (P and F1 males and females: reduced body weight gain, F1 males and females: such as decreased food consumption, necrotic tip or sore of tail, end of tail missing) were observed, a reduced number of live litters and reduced 0-4 day viability in F1 pups were observed, but only lower body weight was observed in F2 pups (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), CLH Report (2011, 2021)). (2) It was reported that, in a two-generation reproduction toxicity study with rats dosed by feeding (150 to 1,350 ppm), at the high dose (1,350 ppm) at which reduced body weight gain and decreased food consumption (except P males) in P and F1 male and female parental animals were observed, reduced luteinization, a reduced number of implantations, an increased percentage of post-implantation loss of embryos, and a reduced percentage of live pups born were observed in F1 female parental animals, and decreased body weight was observed in F1 and F2 pups at or above the mid dose and decreased live pups were observed in F1 at the high dose (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), EFSA (2008), CLH Report (2011, 2021)). (3) It was reported that, in a one-generation reproduction toxicity study with rats dosed by feeding (750 to 3,000 ppm), reduced body weight gain and decreased food consumption in P female parental animals were observed at or above the mid dose (1,500 ppm),; reduced fertility index, reduced numbers of corpora lutea and implantations, increased pre-implantation and post-implantation loss of embryos, and reduced litter size in females and bilateral small and flaccid testes in males (5/15 animals) were observed at the high dose (3,000 ppm),; and only reduced body weight was observed in F1 pups at the low dose (CLH Report (2021)). (4) It was reported that, in a developmental toxicity study with female rats dosed by gavage (10 to 150 mg/kg/day, days 6 to 15 of gestation), reduced body weight gain and decreased food consumption were observed at or above 25 mg/kg/day; a reduction in the number of viable fetuses and an increase in resorptions were observed at the highest dose (150 mg/kg/day) in dams; delayed ossification (skull, vertebra) were observed at or above 25 mg/kg/day; and lower body weights and increased incidences of delayed ossification (sternebra, pelvis) and skeletal variations (wavy ribs) were additionally observed at the highest dose in fetuses (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), EFSA (2008), CLH Report (2011, 2021)). (5) It was reported that, in a developmental toxicity study with female rats dosed by gavage (30 to 120 mg/kg/day, days 6 to 15 of gestation), increases in late resorptions, post-implantation loss rate, and the number of resorbed embryos were observed at the highest dose (120 mg/kg/day) at which reduced body weight gain and decreased food consumption were observed in dams, and fetuses showed delayed ossification (such as seventh cervical vertebra, phalanges, sternebra), skeletal variations (hypoplasia of sternebra, an increase in dumb-bell shaped thoracic vertebra, supernumerary ribs), and visceral variations (renal pelvis dilation) at low doses, and additionally showed lower body weight, delayed ossification (phalanges, caudal vertebra), an increase in split thoracic vertebrae at high doses but no apparent teratogenicity was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), CLH Report (2011, 2021)). (6) It was reported that, in a developmental toxicity study with female rabbits dosed by gavage (1 to 32 mg/kg/day, days 6 to 18 of gestation), cleft palate was observed in two fetuses (1.7%) from two dams that lost weight (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), EFSA (2008), CLH Report (2011, 2021)). (7) It was reported that, in a developmental toxicity study with female rabbits dosed by gavage (5 to 25 mg/kg/day, days 6 to 18 of gestation), increased incidences of visceral anomalies (dilation of heart ventricles and renal pelvis dilation), skeletal variations (accessory floating rib no. 13), and delayed ossification (middle phalange of the fore limb) were observed at the high doses at which reduced body weight gain and decreased food consumption were observed in dams (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), EFSA (2008), CLH Report (2011, 2021)). (8) It was reported that, in a developmental toxicity study with female rabbits dosed by gavage (8 to 32 mg/kg/day, days 6 to 18 of gestation), increased skeletal malformations (vertebral changes between upper cervical and mid-thoracic regions) were observed at the high doses at which reduced body weight gain and cold ears were observed in dams (CLH Report (2011, 2021)). [Reference Data, etc.] (9) In a developmental neurotoxicity test with female rats dosed by gavage during the period from day 6 of gestation to day 21 of lactation (5 to 100 mg/kg/day), no developmental neurotoxicity was observed in pups up to the high doses at which marked maternal toxicity effects (such as reduced body weight gain, increased females with all dead pups) were observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2019), CLH Report (2011, 2021)). (10) In the EU, it was classified in Repr. 2 (EU-CLP Classification Results (Accessed Nov. 2011)). (11) There were no additional significant findings based on which the classification should be changed to Repr. 1B from the previous proposal in 2011 in the review of the EU CLP Classification, and a proposal was made that the classification should remain unchanged at Repr. 2 (CLH Report (2021)). However, as of December 2021, no such opinion by the RAC has been published. |
FY2021 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | No data available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | In 90-day mixed diet administration tests using rats (OECD Guidelines 408), decreased body weight and organ weight were detected at the doses that were different from Category 2 guidance doses (IUCLID (2000)). Similarly, in 90-day mixed diet administration tests using dogs (OECD Guidelines 409), the effects of administration on excretion, body weight gain, and organ weight were detected (IUCLID (2000)) at the doses that were different from Category 2 guidance doses or were equivalent to "Not classified" (oral route) category. Overall, the substance was classified into "Classification not possible" since no studies via other administration routes are available except oral. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. | FY2008 | GHS Classification Guidance by the Japanese Government (Sep, 2008) |
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 72-hour ErC50 = 0.569 mg a.i./L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), Document for registration standards for agricultural chemicals set by the Minister of Environment to prevent harm to animals and plants in areas of public waters, 2014). The classification result was revised from the previous classification by using new information. (a.i.: active ingredient) | FY2021 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN) and it was classified in Category 1 in acute toxicity. The classification result was revised from the previous classification by changing how to classify it in chronic toxicity and using new information. | FY2021 | 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. | FY2021 | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
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