NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-98-9
Chemical Name	2,2-Dimethylpropanoic acid
Substance ID	m-nite-75-98-9_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	It is conceivable that it does not ignite at normal temperatures from an ignition point of >500 degrees C (GESTIS (Access on June. 2011)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for solid substances with a melting point of 140 degrees C or lower.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	An organic compound that contains oxygen which is not chemically bonded to elements other than carbon or hydrogen.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances. Besides, there is information that it is corrosive to cast iron, copper, and zinc (Hommel (1996)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Three LD50 values for rats: 900 to 1800 mg/kg (IUCLID (2000)), 500 to 5000 mg/kg (IUCLID (2000)), and 2000 mg/kg (HPVIS (2009), corresponding to List 2) correspond to Category 4, Category 4 to "Not classified," and Category 4 respectively. It was classified in Category 4 to which most of them correspond.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	From two LD50 values for rats: 1800 to 3600 mg/kg (IUCLID (2000)) and 1900 mg/kg (HSDB (2008)) which correspond to Category 4 to "Not classified" and Category 4 respectively, it is classified in Category 4 to which most of them correspond. From two LD50 values for rabbits: 350 to 2880 mg/kg (IUCLID (2000)) and 3160 mg/kg (HPVIS (2009)) which correspond to Category 3 to "Not classified" and "Not classified" respectively, it is classified as "Not classified" to which most of them correspond. By adopting the higher classification for rats between rats and rabbits, it was classified in Category 4 from the above.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	An LC50 value of not less than a saturated vapour pressure concentration from no deaths after 4-hour exposure to the saturated vapour pressure concentration in rats, and an LC50 value of >4 mg/L/6h (>4.9 mg/L/4h) from 2 deaths out of 10 rats after 6-hour exposure to 4 mg/L in rats were reported. But the classification is not possible because the category could not be determined only by these results.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It was assessed as "highly irritating" resulting from 24, 48-hour average scores of 2.8 and 2.6 for erythema and edema respectively and maximum score of 4 shown in 2 out of 4 animals throughout the 7-day observation period in a Draize test by 24-hour occlusive application of 0.5 mL of this substance to rabbits. (IUCLID (2000)) And it was assessed as "moderately irritating" in another Draize test by 24-hour occlusive application of 0.5 mg of this substance to rabbits. (IUCLID (2000)) From the above, it was classified in Category 2.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It was assessed as "highly irritating" resulting from 24, 48, and 72-hour average scores of 2.0 for conjunctival redness, 2.8 for conjunctival edema, 2.0 for corneal opacity and 1.8 for iritis, and the disappearance of conjunctival edema only at the end of the 7-day observation period in a Draize test applied 0.2 mL of undiluted this substance to rabbits. (IUCILD (2000)) Furthermore, it was assessed as "moderately irritating" result in another test applied 0.1 mL of this substance into rabbit conjunctival sacs. (HPVIS (2009)) Therefore it was classified in Category 2A.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Not classified	- -	-	-	From an assessment result as "not sensitizing" in a maximization test in guinea pigs (OECD TG 406) with a positive rate of 0% (0/20) after a challenge (IUCLID (2000)), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as in vitro tests, both an Ames test and a chromosomal aberration test using rat hepatocytes reported negative results. (IUCLID (2000))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Lack of data. Besides, in a 47-week dermal administration test at a weekly dose of 100 micro g/mouse, it was reported that an increased incidence of skin tumors was not observed (IUCLID (2000)), but neither a statistical analysis of systemic tumors was conducted nor a conclusion was described.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system), Category 3 (narcotic effects)	Warning	H371 H336	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	Observed signs in rats after oral administration were lethargy and piloerection at about 450 mg/kg or higher (IUCLID (2000)) and depression, dyspnea, depressed reflexes, and lack of coordination at 1450 mg/kg or higher. (HSDB (2008), HPVIS (2009)) Observed signs in rabbits after dermal administration were depression, dyspnea, and unsteady gait at doses of 794 mg/kg or higher. (HPVIS (2009)) And described signs in rats or mice after 6-hour inhalation administration of the saturated vapour (4 mg/L) (converted to a 4-hour equivalent value: 4.9 mg/L/4h) were dyspnea, hyperactivity, and prostration. (HSDB (2008)) From the above, the dose in oral administration is within a range of Category 2 in Guidance values, and that in dermal and inhalation administration corresponds to a range of Category 1 in Guidance values, but data are from List 2 and do not meet Decision Criteria 1b3) (OECDTG & GLP compliance test). Therefore, it was classified in Category 2 (central nervous system). In addition, in another 4-hour inhalation administration test to saturated vapour (4 mg/L) in rats, a recovery from observed depression immediately after administration was described. (IUCLID (2000)) It was judged to be transient from the description, therefore, it was classified in Category 3 (narcotic effects).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 28-day oral administration test in rats given at 10 to 300 mg/kg/day, no dose-related effects except transient and mild nasal irritation and adaptive changes in organ weights and clinical tests were observed up to the highest dose of 300 mg/kg/day (converted to a 90-day equivalent: 93.3 mg/kg/day). (IUCLID (2000)) In addition, in a 2-week dermal administration test in rabbits applied at 30 or 300 mg/kg/day, a slight transient body weight loss was observed, but neither dose-related effects in necropsy nor histopathological changes in liver and kidney were found. (HPVIS (2009)) Therefore, it corresponds to "Not classified" in an oral route, but it was classified as "Classification not possible" in specific target organ toxicity (repeated exposure) due to no data in other routes.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Not classified	- -	-	-	It was classified as "Not classified" form 96-hour LC50 >100 mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2009).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. Due to not water-insoluble (water solubility: 21700 mg/L, PHYSPROP Database, 2012), and "Not classified" in acute toxicity, it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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