Item | Information |
---|---|
CAS RN | 4098-71-9 |
Chemical Name | Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl- |
Substance ID | 23B5523 |
Classification year (FY) | FY2011 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
New/Revised | Revised |
Classification result in other fiscal year | FY2006 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition) |
UN GHS document (External link) | UN GHS document |
Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | eChemPortal |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
6 | Flammable liquids | Not classified |
- |
- | - | A flash point of 155 deg C [closed-cup] (ICSC (2008)) is above 93 deg C. |
7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 430 deg C (ICSC (2008)). |
10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not 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 |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon. |
14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | All four LD50 values for rats [4,814 mg/kg, 5,490 mg/kg, > 2,645 mg/kg (the above, SIDS (2006)), 4,825 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004))] correspond to "Not classified" in the Classification JIS (Category 5 in UN GHS classification or "Not classified"). |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | It was classified as "Not classified" based on an LD50 value of > 7,000 mg/kg for rats [OECD TG 402] (SIDS (2006)). |
1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Category 1 |
Danger |
H330 |
P304+P340
P403+P233 P260 P271 P284 P310 P320 P405 P501 |
Both LC50 values (mist) for rats of 0.04 mg/L/4 hours and 0.031 mg/L/4 hours [OECD TG 403; GLP] (SIDS (2006)) correspond to Category 1. |
2 | Skin corrosion/irritation | Category 1 |
Danger |
H314 |
P301+P330+P331
P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501 |
In three tests by 4-hour occlusive (semi-occlusive) application of 0.5 mL of the undiluted test substance to the rabbit skin (all, OECD TG 404), the primary dermal irritation index (PDII) was 6.87, 4.5, and 3.71, and it was all judged as corrosive (SIDS (2006)). Therefore, it was classified in Category 1. Besides, the EU classified it in R36/37/38 (EC-JRC (ESIS) (Access on Sept. 2011)). |
3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
It was assessed as corrosive in a test in which 0.1 mL of the undiluted test substance was applied to the rabbit eye (OECD TG 405) (SIDS (2006)), but the irritation index (equivalent to AOI) was 36.4 (/110). It was classified in Category 2A based on the irritation index. Besides, it was reported to be not irritating with the irritation index (equivalent to AOI) of 9.96 (/110) in another test with rabbits (OECD TG 405), and exudation in the eye was seen at 1 and 24 hours in the test. Also, it is mentioned that all the animals showed loss of hair around the eye and incrustation at the eyelid associated with thickening after ten days after treatment, which was not reflected in the scores (SIDS (2006)). By considering this, it was concluded in SIDS (2006) that this substance is severely irritating to the eye as a whole (SIDS (2006)). |
4 | Respiratory sensitization | Category 1 |
Danger |
H334 |
P304+P340
P342+P311 P261 P284 P501 |
In humans, there is a case report in which a person developed severe asthma after occupational exposure, a bronchial inhalation test gave a positive response to this substance, and he had respiratory hypersensitivity (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), SIDS (2006)). Furthermore, this substance is listed as a respiratory sensitizer by the Japanese Society of Occupational and Environmental Allergy (List of sensitizing substances by ALGY society), Deutsche Forschungsgemeinschaft (DFG) (MAK/BAT (2010)), and the American Conference of Governmental Industrial Hygienists (ACGIH (2001)), and the EU classified it in R42/43 (EC-JRC (ESIS) (Access on Sept. 2011)). Based on the above knowledge, it was classified in Category 1. |
4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
It is reported that in two maximization tests with guinea pigs (OECD TG 406), it was sensitizing in both with positive rates of 75% (15/20) and 95% (19/20) (SIDS (2006)), and also in two Buehler tests with guinea pigs, it was sensitizing in both with positive rates of 75% (15/20) and 95% (19/20) (SIDS (2006)). On the other hand, anomalies in the skin were also seen after exposure in humans, and there are reports on multiple cases in which persons were patch tested positive to this substance (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004), SIDS (2006)). It was classified in Category 1 based on the above knowledge of animals and humans. |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | It was classified as "Not classified" based on a negative result in a micronucleus test with erythrocytes after inhalation administration to mice (in vivo somatic cell mutagenicity test) (SIDS (2006)). Besides, as for in vitro tests, there are reports on a negative result in an Ames test (SIDS (2006), NTP DB Study ID 225422 (1982)) and a positive result in a chromosomal aberration test with Chinese hamster ovary cells (SIDS (2006)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | No data available. |
7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a developmental toxicity test by inhalation exposure of rats on gestational days 6-19, general toxicity was seen in maternal animals, including reduced weight gain, decreased food consumption, and effects on the respiratory tract, in the highest dose, while developmental toxicity was limited to decreased fetal body weight, delayed descensus testis, and retarded ossification found at the same dose, and no other effects, including teratogenicity, were observed (SIDS (2006)). Therefore, there were no adverse effects on the development of offspring, but effects on sexual function and fertility are unknown, and it was classified as "Classification not possible" due to insufficient data. |
8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory system) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
After inhalation exposure (mist) of rats, signs of respiratory tract distress (tachypnea, bradypnea, stridor) were seen at or above 0.020 mg/L/4 hours, and six out of ten animals died at 0.533 mg/L/4 hours. In necropsy of dead animals, a less collapsed lung and some focal discoloration of the lung were sporadically observed, and the nose/muzzle with red incrustations, mucous membranes of the nose with reddening, the pleural cavity filled with liquid, and the lung less collapsed emphysematous were seen (SIDS (2006)). Furthermore, after inhalation exposure (mist) of mice, bradypnea, labored breathing, and stridor were found at or above 0.005 mg/L/6 hours (converted 4-hour equivalent value: 0.0075 mg/L) (SIDS (2006)). Because the above findings were seen at doses corresponding to the guidance value range for Category 1, it was classified in Category 1 (respiratory system). Besides, in a test by exposure of human volunteers for 1-5 minutes, strong irritation of the respiratory tract was reported at 0.00137 mg/L (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory system) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
In a 4-week inhalation exposure test with rats (vapour), pulmonary edema was observed at 1.37 mg/m3/4 hours (converted guidance value: 0.31 mg/m3/6 hours/day) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)). Furthermore, in another 4-week inhalation exposure test with rats (OECD TG 412; GLP), at 4 mg/m3/6 hours (converted guidance value: about 1.3 mg/m3/6 hours), in addition to respiratory tract irritation found, the pharynx, trachea, and lung were affected, and recovery in the lung and trachea was complete during the 4-week recovery period, but lesions in the nasal cavity, pharynx, and larynx still occurred in some animals with minimal or slight degree (SIDS (2006)). Because the above findings were seen at doses corresponding to the guidance value range for Category 1, it was classified in Category 1 (respiratory system). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 |
P273
P501 |
It was classified in Category 3 from 24-hour EC50 = 83.7 mg/L for crustacea (Daphnia magna) (IUCLID, 2000). |
11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
Reliable chronic toxicity data were not obtained. Because it is not rapidly degradable (in a 2-week test on a degradation rate, it changes in the test solution to generate 3-aminomethyl-3,5,5-trimethylcyclohexylamine (not readily degradable (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2000)) and its intermediates (3-isocyanatomethyl-3,5,5-trimethylcyclohexylamine or 3-aminomethyl-3,5,5-trimethylcyclohexylisocyanate) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and it was classified in Category 3 in acute toxicity, it was classified in Category 3. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
|