GHS Classification Result

Chemical Name:musk xylene; 5-tert-butyl-2,4,6-trinitro-m-xylene
CAS:81-15-2

Result:
ID: 20A2011
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 Not classified - - - - According to the United Nations' classification, the substance fits in Division 4.1 III: flammable substance class, flammable substances, and is not considered to be an explosive. Thus, the substance was classified into "Not classified".
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 Category 2 Warning H228: Flammable solid P370+P378: In case of fire: Use ... for extinction.
P210: Keep away from heat/sparks/open flames/hot surfaces. ? No smoking.
P240: Ground/bond container and receiving equipment.
P241: Use explosion-proof electrical/ventilating/lighting/.../equipment.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
According to the conventional classification, the substance falls under UNRTDG 4.1 III. Based on the information, the substance was classified into Category 2.
8 Self-reactive substances and mixtures Classification not possible - - - - Classification is not possible since its relevant properties were unknown.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Since the substance falls under UNRTDG 4.1, it was classified into "Not classified".
11 Self-heating substances and mixtures Not classified - - - - Since the substance falls under UNRTDG 4.1, it was classified into "Not classified".
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 classified - - - - Although there are no data available using standardized testing methods, EU-RAR (2005) documented that the substance is not oxidizing, and it falls under UNRTDG Division 4.1. Thus, the substance was classified into "Not classified".
15 Organic peroxides Not applicable - - - - 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) Not classified - - - - Based on the rat LD50 > 1000mg/kg (IARC (1996), EU-RAR (2005)), the substance was classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Based on the rabbit LD50 > 15000mg/kg (IARC (1996), EU-RAR (2005)), 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) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - While no skin irritation was detected in rabbit studies (EU-RAR, 2005), mild irritation was observed in acute dermal toxicity tests with humans (EU-RAR, 2005). However, details on irritation scores and tests themselves were lacking, and thus, the substance was classified into "Classification not possible".
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 studies that followed the OECD guidelines 405, iritis and conjunctivitis were observed. All 3 animals that developed iritis scored 1, and they recovered within 48 hours after the treatment. All 3 animals that developed conjunctivitis scored 1, and they recovered within 10 days after the treatment (EU-RAR, 2005). From these results, the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - The documented open epicutaneous tests and photoallergy tests using guinea pigs do not provide sufficient information for evaluation, and no conclusions can be drawn in terms of skin sensitization (EU-RAR, 2005). However, in the contact sensitization tests involving 25 healthy people to whom irritation-triggering concentrations were applied, no positive reactions were observed by challenge (EU-RAR, 2005). Furthermore, in the patch test in which 192 dermatological patients participated, no allergic reactions were observed (EU-RAR, 2005). These results led to the conclusion that musk xylene is not a skin sensitizer (EU-RAR, 2005). Based on the information, the substance was classified into "Not classified".
5 Germ cell mutagenicity Classification not possible - - - - All of the in vivo UDS tests using rat hepatocytes (in vivo genotoxicity tests using somatic cells) and several in vitro mutagenicity tests yielded negative results (IARC (1996), EU-RAR (2005)). However, since these tests did not provide sufficient data, the classification is not possible.
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer 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 ...
The substance has been classified into cat. 3 by the EU (EU-RAR, 2005) and Group 3 by IARC (2001). Based on EU's rating, which is more up-to-date than that of IARC, the substance was classified into Category 2. As relevant notes, frequencies of tumorigenesis increased in mice that were orally administered for 80 weeks (liver and Harderian gland) (EU-RAR, 2005).
7 Reproductive toxicity Classification not possible - - - - In oral administration tests using pregnant rats during the organogenetic period, general toxicity, such as decreased body weight and food consumption, was observed in parental animals. In terms of reproduction, no adverse effects including teratogenicity were detected, with the exceptions of supernumerary ribs and advanced ossification of hyoid bones and bones of digits observed at high doses. Despite these results, classification is not possible due to insufficient data regarding effects on sexual functions and fertility in parental animals.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No abnormalities were detected in the acute toxicity test using mice, except for tremors and a case of death observed at 4000mg/kg (EU-RAR (2005)). The reference lacks sufficient details, however.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In preliminary tests for carcinogenicity studies, in which mice were fed food containing the substance for 17 weeks, the maximum tolerated dose was 0.15% (214mg/kg/day) (EU-RAR, 2005). In addition, in the dermal administration tests in which rats were given a high dose at 240mg/kg/day for 90 days, increased liver weight was observed but was considered to be histopathologically trivial (EU-RAR, 2005) and not a significant toxic effect. Although serious effects were not observed at the doses equivalent to the guidance values in both studies, these tests were either preliminary or skin tests only. Therefore, these data were insufficient for the assessment of systematic toxicity, and thus classification is not possible.
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 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Since 96h LC50 = 1.2mg/L for fish (bluegills) (EU, 2005), it is classified into Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2 - H411: 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 2 and it is not rapidly degradable (non-biodegradable, BOD degradability: 2%, Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2003), the substance was classified into Category 2.


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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