GHS Classification Result

Chemical Name:5,5-dimethyl-perhydro-pyrimidin-2-one alpha-(4-trifluoromethylstyryl)-alpha-(4-trifluoromethyl)cinnamylidenehydrazone
CAS:67485-29-4

Result:
ID: 20A2295
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Classification not possible - - - - The substance contains chemical groups (N-N) associated with explosive properties. No data are available.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solid Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - The substance contains chemical groups (N-N) associated with explosive properties. No data are available.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases 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).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance contains fluorine (but not oxygen or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Based on its rat LD50 values: 1131 mg/kg for male and 1300 mg/kg for female (HSDB (2009)), the substance was classified into Category 4.
1 Acute toxicity (Dermal) Not classified - - - - Based on its rabbit LD50 of > 5000 mg/kg (HSDB (2009)), the substance was classified into "Not classified".
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified - - - - Based on its rat LC50 of > 5000 mg/m3 (conversion value: > 5 mg/L), the substance was classified into "Not classified" using the JIS classification criteria (Category 5 or "Not classified" category using the United Nations classification). Since its saturated vapour pressure concentration is 5.39E-07 mg/L, we judged that the experiment was conducted in a mist state.
2 Skin corrosion/irritation Not classified - - - - Since the substance is reported to be not irritating in rabbit tests (HSDB (2009)), not a skin irritant (HSDB (2009)), and not skin irritating in tests using guinea pigs (HSDB (2009)), it was classified into "Not classified".
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
In rabbit tests, though specific scores were not provided, corneal opacity, conjunctival redness, or chemosis appeared, and these symptoms were found to be reversible based on a 7-day observation. In addition, the substance was documented to cause moderate corneal irritation (HSDB (2009)) and reversible irritation in rabbit tests (HSDB (2009)). Based on this information, the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - The substance is documented to be not sensitizing in the tests using guinea pigs (HSDB (2009)), and not skin sensitizing (HSDB (2009)). This information indicates the placement of the substance into "Not classified" category; however, since these studies are based on List 2 datasets, the substance was classified into "Classification not possible".
5 Germ cell mutagenicity Classification not possible - - - - Classification is not possible due to lack of in vivo test data using germ cells or somatic cells. Regarding in vitro studies, Ames tests (HSDB (2009)) and chromosomal aberration tests using CHO cells (HSDB (2009)) both yielded negative results.
6 Carcinogenicity Classification not possible - - - - 76-week oral administration tests using mice found tumorigenesis in the lung, thorax, or respiratory tracts, and development of bronchogenic carcinoma; but it is suspected that tumors were spontaneously generated (RTECS (2007)). Based on these documents alone, however, it is difficult to evaluate carcinogenicity of the test substance. Since there are no other appropriate animal study information available, the substance was classified into "Classification not possible".
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
In 2-generation oral administration tests using rats (doses: 0, 25, 50 or 75 ppm), degeneration of seminiferous tubules was detected in male rat groups exposed to 50 ppm or higher doses; though its toxicity in parental animals is not clear, a decreased mating in F1 male groups treated with high doses, decreased pregnancy in F1 female groups, decreasing tendency in implantation rates, and decreased litter size were observed (HSDB (2009)). In addition, in forced oral administration tests using rats (doses: 0, 3, 10 or 30 mg/kg/day; days 6-15 of gestation), slight ossification delays such as incomplete supraoccipital ossification, and increased incidence of rudimentary ribs were identified at the exposure rate (30 mg/kg/day) which induces parental toxicity (HSDB (2009)). Though its effect on teratogenicity is not clear, because of observed decrease in pregnancy and implantation rates in F1 female and a decreased litter size, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Category 2 (testis, kidney, nervous system) Warning H373: May cause damage to organs through prolonged or repeated exposure (testis, kidney, nervous system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In 28-day oral administration tests using rats (dose: 0, 50, 100, 200, 400 or 800 ppm), testicular lesions (especially focal tubular degeneration and formation of giant cells) were observed in male rat groups administered at >= 200 ppm (18.7 mg/kg/day: 90-day correction value: 5.81 mg/kg/day) (HSDB (2009)). In addition, in 91-day oral administration tests using rats (dose: 0, 25, 50, 100 or 200 ppm), the weight of testes decreased in all dose groups in a dose-dependent fashion, and testicular atrophy at >= 100 ppm (8.6 mg/kg/day) and mild prostatic atrophy at 200 ppm (17.0 mg/kg/day) were observed (HSDB (2009)). Furthermore, in 2-year oral administration tests using rats (dose: 0, 25, 50, 100 and 200 ppm), development of glomerulonephrosis was found in female groups treated with 50 ppm or higher and male groups treated with 25 ppm or higher in a dose-dependent fashion, and testicular atrophy was detected in male groups exposed to 50 ppm or higher (the symptom was especially notable at 100 and 200 ppm) (HSDB (2009)). Moreover, in 18-month oral administration tests using mice (dose: 0, 25, 100 and 200 ppm), chronic nephritis and kidney amyloidosis were identified in both sexes exposed to 50 ppm (conversion value: 7.5 mg/kg/day) or higher, and testicular degeneration occurred in male rats exposed to 50 ppm or higher. Also, in 91-day oral administration tests using dogs (dose: 0, 3, 6 or 12 mg/kg/day), tremors, convulsions, or wastage of muscle and subcutaneous fat were found in both sex groups exposed to 6 or 12 mg/kg/day; and mild to moderate bilateral testicular atrophy was observed in male groups exposed to 6 or 12 mg/kg/day (HSDB (2009)). Overall, effects of administration on the testes and kidney were detected in rats and mice at Category 1 guidance doses; and the effects on the nervous system in forms such as tremors and convulsions were recognized in dogs. Since these studies were based on List 2 data sets, the substance was classified into Category 2 for the testis, kidney and nervous system.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Based on its 72-hour EC50 of 0.00018 mg/L for algae (Skeletonema) (ECOTOX, 2008), the substance was classified into Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Since its classification for acute toxicity is Category 1, and it is not rapidly degradable (SRC: BioWin V4.10), the substance was classified into Category 1.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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