NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	81-14-1
Chemical Name	3,5-Dinitro-2,6-dimethyl-4-tert-butylacetophenone; Musk ketone
Substance ID	25A0009
Classification year (FY)	FY2013
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
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	Classification not possible	- -	-	-	There is a chemical group containing oxygen associated with explosive properties in the molecule, and an oxygen balance of -174 is higher than the criteria of -200. However, the classification is not possible due to no data on the prescribed test for explosives.
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	- -	-	-	There is a chemical group associated with explosive properties in the molecule, but the classification is not possible due to no data.
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	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data.
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	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	It was classified as "Not classified" based on a report on an LD50 value of > 2,000 mg/kg for rats (EU-RAR (2005)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on a report on an LD50 value of > 2,000 mg/kg for rabbits (EU-RAR (2005)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, no signs of dermal irritation are described in a test with rabbits (EU-RAR (2005)), but application time, etc, are unknown.
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It is described in EU-RAR (2005) that in a test with rabbits according to OECD TG 405, there was no irritation to rabbit eyes. It was classified as "Not classified" based on the above information.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is described in EU-RAR (2005) that it was weakly positive in a maximization test with guinea pigs (OECD TG 406). Furthermore, it is reported that in two maximization tests with volunteers, no sensitization was observed with a 3.2% solution.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, a negative result is reported in a micronucleus test with mice (EU-RAR (2005)). As for in vitro, it was negative in a bacterial reverse mutation test, a mouse lymphoma test with cultured mammalian cells, and a micronucleus test with cultured human-derived cells (EU-RAR (2005), HSDB (Access on October 2013), NTP DB (Access on October 2013)), and there was an equivocal result in a chromosomal aberration test with cultured mammalian cells (EU-RAR (2005), HSDB (Access on October 2013)).
6	Carcinogenicity	Classification not possible	- -	-	-	There are no carcinogenicity data. It is classified in "Carc. Cat 3; R40" in EU DSD classification and "Carc.2 H351" in EU CLP classification, but the information used could not be obtained. Therefore, it was classified as "Classification not possible."
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a developmental toxicity test with rats in the oral route (gavage), developmental toxicity (increased post-implantation resorptions, reduced fetal body weight) was observed at the dose where maternal toxicity (weight gain reduction, food consumption reduction) occurred (EU-RAR (2005)). No information on the effects on fertility was obtained. Therefore, it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	It was classified in Category 3 (narcotic effects) because hyperexcitability, depression, coma, etc. were observed in rats after gavage administration at doses (2,500-10,000 mg/kg) above the guidance value range.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	It is described that in a 90-day dermal exposure test with rats, weight gain reduction was observed in females at the dose (75 mg/kg/day) within the guidance value range for Category 2 (EU-RAR (2005), HSDB (Access on October 2013)), but it was not adopted as the rationale for classification because it is slight (about 10%) and a change only in one sex. Besides, in the test, anemia findings and increased liver weight were found in males and females at the dose (240 mg/kg/day) above the guidance value for Category 2 (EU-RAR (2005), HSDB (Access on October 2013)). From the above, it corresponds to "Not classified" in the dermal route. However, because there is no toxicity information on the other routes, it was classified as "Classification not possible" due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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 1	Warning	H400	P273 P391 P501	From 72-hour ErC50 = 0.24 mg/L for algae (Pseudokirchneriella subcapitata) (EU-RAR, 2005), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, it was classified in Category 1 due to being not rapidly degradable (not biodegradable in an inherent biodegradation test (EU-RAR, 2005)), and 72-hour NOEC = 0.088 mg/L for algae (Pseudokirchneriella subcapitata) (EU-RAR, 2005).
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.

To GHS Information