NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	25265-77-4
Chemical Name	2,2,4-Trimethylpentane-1,3-diol monoisobutyrate [Texanol]
Substance ID	m-nite-25265-77-4_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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	A flash point is 122 deg C (closed cup) (GESTIS (Access on September 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 393 deg C (GESTIS (Access on September 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 reports of LD50 values of > 3,200 mg/kg (SIDS (2002)), 6,517 mg/kg (SIDS (2002), PATTY (6th, 2012)) for rats, this substance was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	There is a report of an LD50 value of > 16 mL/kg (> 15,200 mg/kg) (SIDS (2002), PATTY (6th, 2012)) for rabbits, and it corresponds to "Not classified." There is a report of an LD50 value of > 20 mL/kg (> 19,000 mg/kg) (SIDS (2002), PATTY (6th, 2012)) for guinea pigs, and it corresponds to "Not classified." From the above, this substance was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on a report of > 3.55 mg/L (converted 4-hour equivalent value: > 5.33 mg/L) (SIDS (2002), PATTY (6th, 2012)) as the LC50 value for rats in a 6-hour inhalation exposure test, it was classified as "Not classified." Besides, the exposure concentration is higher than the saturated vapor pressure concentration (12.9 ppm (0.114 mg/L)), so the reference value in the unit of mg/L as mist was applied.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in a skin irritation test (according to EU Method B.4) with rabbits, it showed mild irritation when this substance was applied for 4 hours (ECHA registration information (Access on December 2017)). In addition, there is a description that in two skin irritation tests with guinea pigs, mild irritation was shown despite long-time application in both (SIDS (2002)). Therefore, it was judged that this substance has mild irritation, and it was classified as "Not classified" (Category 3 in UN GHS classification).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	There is a description that in an eye irritation test (similar to OECD TG 405) with rabbits, a grade 2 redness of the conjunctiva was produced 24 hours after application, the maximum score in an unwashed eye was 4 (maximum 110), and it was a slight to moderate eye irritant (SIDS (2002), PATTY (6th, 2012)). In addition, there is a description that in another study with rabbits, mild irritation was observed (ECHA registration information (Access on December 2017)). Therefore, it was judged that it has mild irritancy, so it was classified in Category 2B.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	There is a description that in a skin sensitization test (according to OECD TG 406) with guinea pigs, no sensitization was observed (SIDS (2002), PATTY (6th, 2012)). However, it was classified as "Classification not possible" because no information on humans was obtained.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test with mouse bone marrow cells was negative, and as for in vitro, a bacterial reverse mutation test was negative (SIDS (2002), PATTY (6th, 2012)). From the above, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, effects on the liver (increased liver weight, centrilobular hypertrophy of hepatocytes) at or above 300 mg/kg/day in maternal animals were observed, but no reproductive or developmental effect was observed at up to 1,000 mg/kg, which was the limit dose (PATTY (6th, 2012), SIDS (2002)). However, it is difficult to classify it as "Not classified" with only this result since this test is a screening test, and no other data are available for the classification. Therefore, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. In humans, among painters reporting feelings of discomfort from the use of water-based paints, as temporary health effects, decreased vital capacities, increased urine volumes and increased mean corpuscular volumes were observed. Although this substance was detected in the air sample collected in the respiration zone of the workers, the study population was small, so it was evaluated that it was impossible to derive a conclusion from this research result (PATTY (6th, 2012)). Therefore, this information was not adopted as evidence. As for experimental animals, there is a report that in a single-oral dose test with rats, slight transient weakness, rough coat, vasodilation, and labored breathing were observed at 3,200 mg/kg, which is above Category 2 (PATTY (6th, 2012)). However, the target organs could not be specified by these effects. It was classified as "Classification not possible" due to no other information.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no information in humans. As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, salivation (due to the taste of the test substance) and an increase in liver weight at or above 100 mg/kg/day (converted guidance value: 44-57 mg/kg/day) within a guidance value range of Category 2, centrilobular hypertrophy and eosinophilia (degeneration of ground-glass appearance) of the hepatocytes in the liver, and hyaline droplets in the kidney (males only) at or above 300 mg/kg/day (converted guidance value: 133-170 mg/kg/day) greater than a guidance value range of Category 2, and an increase in kidney weight (males only) at 1,000 mg/kg/day (converted guidance value: 444-567 mg/kg/day) were observed. The findings of the liver in this study are considered to be associated with increased metabolism, and the findings of the kidney are considered to be unique to male rats (SIDS (2002)). From the above, no effect to be the evidence of the classification was observed, so it corresponds to "Not classified" in the oral route. However, it was classified as "Classification not possible" because no data on effects of other routes are available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 13.58 mm2/sec (25/20 deg C) from the numerical data (Viscosity: 12.9 mPa*s (25 deg C), density: 0.95 g/cm3 (20 deg C)) listed on GESTIS (Access on August 2017).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 3	- -	H402	P273 P501	From 72-hour EC50 (area method) = 18.4 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 1994), it was classified in Category 3.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Due to being rapidly degradable (BioWin), no bioaccumulation (LogPow: 3 (SRC PhysProp Database (2017))), and 72-hour NOEC (area method) = 3.28 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 1994), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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