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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	56539-66-3
Chemical Name	3-Methoxy-3-methyl-1-butanol
Substance ID	24A6010
Classification year (FY)	FY2012
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)	Physical Hazards and 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	Category 4	- Warning	H227	P370+P378 P403+P235 P210 P280 P501	Because both flash points of 68 deg C [closed-cup] ( 16112 Chemical Products (The Chemical Daily Co., Ltd.,)) and 71 deg C [closed-cup] (MSDS (Sigma-Aldrich) (Access on May 2012)) are >60 deg C and <= 93 deg C, it corresponds to Category 4.
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 395 deg C (SIDS (Access on May 2012)).
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 or hydrogen.
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	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification or "Not classified") based on LD50 values for rats of > 2,000 mg/kg [OECD TG401; GLP] and 4,400 mg/kg (OECD TG401; GLP-compliant) (SIDS (Access on May 2012)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" because there was no death after administration of 2,000 mg/kg to rats, and an LD50 value was > 2,000 mg/kg (Test Guideline of the Ministry of Agriculture, Forestry, and Fisheries of Japan; GLP-compliant) (SIDS (Access on May 2012)).
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)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Not classified	- -	-	-	In a test by a 4-hour occlusive application of 0.5 mL of the test substance to the skin of six rabbits (EPA OPP 81-5; GLP-compliant), slight erythema was observed in one animal at a concentration (of the test substance) of 100% only at 24 hours after the removal of the patch, and it was assessed to be not irritating (SIDS (Access on May. 2012)). Therefore, it was classified as "Not classified." Besides, as for humans, it is reported that in a patch test on a total of 41 male and female subjects, it was judged to be negative (SIDS (Access on May. 2012)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In a test in which 0.1 mL of the undiluted test substance was applied to the rabbit eye (EPA OPP 81-4; GLP-compliant), slight corneal opacity, slight iritis, moderate to severe conjunctival responses, and slight to severe discharge were observed in six animals in the non-rinsed group, four of them returned to normal by seven days after application, the remaining two fully recovered by 9-10 days, and it was assessed to be moderately irritating (SIDS (Access on May. 2012)). Therefore, it was classified in Category 2A.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Not classified	- -	-	-	It was classified as "Not classified" because in a maximization test with guinea pigs (GLP-compliant), no animals showed positive responses, a positive rate of 0% (0/10), and it was not sensitizing (SIDS (Access on May 2012)). Besides, a photosensitization test with guinea pigs was also conducted, and it is reported that none of the 10 test animals showed positive responses, and it was not sensitizing (SIDS (Access on May 2012)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, there is a report on negative results in both an Ames test (OECD TG471, GLP-compliant) and a chromosomal aberration test (GLP-compliant) with cells derived from Chinese hamster lung (JECDB (2002)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Not classified	- -	-	-	In a reproduction/developmental toxicity screening test with rats (OECD TG421; GLP-compliant) in which males were orally dosed for 47 days from 14 days before mating, and females were orally dosed from 14 days before mating to day 4 of lactation after delivery throughout the mating and gestation period, in parent animals, significant increases in weights of the liver and kidney were observed in the groups of 200 and 1,000 mg/kg as general toxicity, but there were no changes in reproductive parameters such as estrous cycle, copulation rate, fertility rate, gestation length, the number of corpus luteum, number of implantations, implantation rate, delivery rate, and parturition rate. In offspring, no changes in the development of offspring were observed in the number of pups born, sex ratio, live birth rate, general appearance, the viability on day 4 of lactation, etc. even at the highest dose (1,000 mg/kg group) (JECDB (Access on May 2012)). And in a developmental toxicity test with pregnant rats orally dosed during the organogenesis period (FDA Guidelines; GLP-compliant), maternal animals showed decreases in weight gain and food consumption at all of 250, 500, and 2,000 mg/kg bw/day, but as for the development of offspring, no effects on the numbers of implantation sites, resorptions, live and dead fetuses were found except for decreased body weights seen at the high dose (2,000 mg/kg bw/day), and no increase in the incidence of malformations was detected after administration (SIDS (Access on May 2012)). From the above, because no adverse effects on sexual function/fertility or adverse effects on the development of offspring were observed, it was classified as "Not classified."
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In an acute oral toxicity test with rats, there was no death after administration of 1,000 or 2,000 mg/kg, some animals showed slightly reduced motor activity at 2000 mg/kg, the upper limit of the guidance value range, body weights smoothly increased, and no abnormalities were observed in the internal organs at necropsy after the end of the observation period (JECDB (Access on May 2012)). And also in an acute dermal administration test with rats (Test Guideline of the Ministry of Agriculture, Forestry, and Fisheries of Japan; GLP-compliant), there was no death at 2,000 mg/kg, the upper limit of the guidance value range, and no clinical signs or abnormalities at necropsy were found (SIDS (Access on May 2012)), corresponding to "Not classified." From the above results, it corresponds to "Not classified" in the oral and dermal routes. However, there are no data and effects are unknown in the inhalation route. Therefore, it was classified as "Classification not possible" for specific target organ toxicity (single exposure).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 28-day repeated oral administration toxicity test with rats, significant increases were observed in kidney weights at or above 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day) and liver weights at 1,000 mg/kg (converted guidance value: 311 mg/kg/day), but no changes due to treatment were found in the other tests including the histopathological examination (JECDB (Access on May 2012)). And in a reproduction/developmental toxicity screening test, kidney weights significantly increased at or above 200 mg/kg/day (converted guidance value: about 100 mg/kg/day), but no changes due to treatment were seen in the kidney in histopathological examination (JECDB (Access on May 2012)). Therefore, because no adverse effects were shown at the doses above the guidance value range, it corresponds to "Not classified" in the oral route. On the other hand, in a 4-week inhalation exposure test with rats, an increase in GOT and an increase in kidney weights were observed at or above 100 ppm (converted guidance value: 0.122 mg/L), but no histopathological changes were seen (SIDS (Access on May 2012)). Because the highest concentration in the test of 500 ppm (converted guidance value: 0.613 mg/L) was within the guidance value range, effects around the upper limit of the guidance values are unknown. Furthermore, due to no data on dermal administration, it was classified as "Classification not possible" for specific target organ toxicity (repeated exposure).
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)	Not classified	- -	-	-	It was classified as "Not classified" because acute toxicity is not reported at 100 mg/L for algae, crustacea, and fish (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003), SIDS (2005)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 110% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2003)), and 21-day NOEC = 100 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003), SIDS (2005)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 110% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2003)), a low bioaccumulation estimate (LogKow = 0.18, SIDS, 2005), and corresponding to "Not classified" in acute toxicity for fish (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003), SIDS (2005)). From the above results, it was classified as "Not classified."
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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