NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	81-15-2
Chemical Name	musk xylene; 5-tert-butyl-2,4,6-trinitro-m-xylene
Substance ID	m-nite-81-15-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

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	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".	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	Category 2	Warning	H228	P370+P378 P210 P240 P241 P280	According to the conventional classification, the substance falls under UNRTDG 4.1 III. Based on the information, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Classification is not possible since its relevant properties were unknown.	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	Not classified	- -	-	-	Since the substance falls under UNRTDG 4.1, it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Since the substance falls under UNRTDG 4.1, it was classified into "Not classified".	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	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".	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	-	- -	-	-	-	-	-

HEALTH HAZARDS

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)	Not classified	- -	-	-	Based on the rat LD50 > 1000mg/kg (IARC (1996), EU-RAR (2005)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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".	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)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	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.	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	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".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	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）

ENVIRONMENTAL HAZARDS

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 2	- -	H401	P273 P501	Since 96h LC50 = 1.2mg/L for fish (bluegills) (EU, 2005), it is classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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