GHS Classification Result

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GENERAL INFORMATION
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

REFERENCE INFORMATION
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

PHYSICAL HAZARDS
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.

HEALTH HAZARDS
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.

ENVIRONMENTAL HAZARDS
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.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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