NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	140-66-9
Chemical Name	4-(2,4,4-Trimethylpentan-2-yl)phenol
Substance ID	m-nite-140-66-9_v2
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)	- -	-	-	Solid (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)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	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 (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 410 deg C (GESTIS (Access on June 2017)).	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 solid (melting point <= 140 deg C) 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)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	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))
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	- -	-	-	Test methods applicable to solid substances are not 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 a reported LD50 value for rats of > 2,000 mg/kg (SIDS (2005)), it was classified as "Not classified." Besides, the information of 4,600 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)) used in the previous classification was from RTECS, the information source listed in List 3, the original source could not be obtained, and the details could not be confirmed. Therefore, this information was not adopted.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Based on a reported LD50 value for rabbits of 1,880 mg/kg (SIDS (2005)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that the LC100 value was not more than 116 mg/L (converted 4-hour equivalent value: 29 mg/L) in a test in which rats were exposed by inhalation for one hour to aerosols of this substance of 89% purity (SIDS (2005)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	As for humans, this substance was described to be slightly irritating to the skin (SIDS (2005)). In a skin irritation test with rabbits (following OECD TG 404), it was reported that this substance was mildly irritating to the skin (SIDS (2005)). Therefore, this substance was classified as "Not classified" (Category 3 in the UN GHS classification). Besides, this substance was classified as Skin Irrit. 2 in the EU CLP classification (ECHA CL Inventory (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, GLP, 24-hour observation) with rabbit (n=1), corneal opacity, iridial inflammation, and severe conjunctival irritation were caused, but there was no information on whether the symptoms were irreversible (AICIS IMAP (2018), SIAR (1995), REACH registration dossier (Accessed Dec. 2021)). (2) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, 21-day observation) using a mixture of isomers with rabbits (n=6), all animals showed corneal opacity, iritis, conjunctival redness, and chemosis 24 hours after treatment, and the irritation effects except chemosis were not fully reversible within 21 days (corneal opacity score: 1.3/1.3/1.3/1.3/1.3/2, iritis score: 1/1/1/1/1/1, conjunctival redness score: 1.7/2/2.7/2.7/3/3, chemosis score: 1.7/1.7/2.7/2.3/2.3/2.3) (AICIS IMAP (2018), REACH registration dossier (Accessed Dec. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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	- -	-	-	This substance was reported to be negative in a sensitization test with guinea pigs (following OECD TG 406) (SIDS (2005)). However, the result comes from one test only, and details such as the response rate in the positive controls are unknown. Therefore, this substance was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is no in vivo data. As for in vitro data, this substance was negative in bacterial reverse mutation tests and a chromosome aberration test with cultured mammalian cells (JECDB (Access on June 2017), SIDS (2005)).	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	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	A reproduction/developmental toxicity screening test with rats dosed by gavage revealed decreases in the conception rate and the implantation rate, prolonged duration of pregnancy, and developmental delay at 500 mg/kg/day. However, as this dosage caused a markedly high death rate of 54% in the dams (13 cases out of 24), the reproductive/developmental effects were considered to be secondary effects (SIDS (2005)). It is also reported that slight delays were observed in the days of age of vaginal opening and preputial separation in the pups in a two-generation study with rats dosed by feeding (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)), and that a delay in sexual maturation and changes in the weights of male genetic organs thought to be associated with reduced body weights were observed in a study in which neonatal rats were dosed by gavage on postnatal days 1-5 (Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003)). However, these effects were minor and difficult to be adopted as rationale for classification. Meanwhile, It is also reported that increased post-implantation embryo-fetal deaths were observed at the doses with maternal toxicity (reduced body-weight gain and reduced food consumption) (31.3 mg/kg/day or higher) in a developmental toxicity study in which pregnant rats were dosed orally during early pregnancy (days 0-8 of pregnancy) (Catalog of Teratogenic Agents, 11th ed.: Harazono, A. and Ema, M. (2001): Toxicol. Lett., 119, 79-84 (primary source confirmed)). Therefore, this substance was classified in Category 2 on the basis of increased embryo-fetal deaths at the doses with maternal toxicity.	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 the previous classification, this substance was classified in Category 3 (narcotic effects) on the basis of the information from IUCLID (2000) that mild sedation and ataxia were observed in an acute oral toxicity test in rats. However, since the information of IUCLID was not available and the details were unknown, it was not adopted. As there is no other information that provides a basis for classification, this substance was classified as "Classification not possible." Besides, it is stated in the ECHA registration dossier (Access on July 2017) that, in a single oral dose test in rats, ruffled fur, crouched posture, slight sedation and ataxia, diarrhea, diuresis, prone position, hypothermia, cyanosis, labored breathing, staggering, and trembling were observed 30 minutes after administration at or above 3,160 mg/kg exceeding the range of Category 2, and that dissection of surviving animals showed hyperemia of the small intestine; swelling of the gastric mucosa; and fusion of the liver, stomach, and spleen with the peritoneum.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney)	Warning	H373	P260 P314 P501	No information on humans is available. As for experimental animals, in a 28-day repeated oral dose toxicity test with rats dosed by gavage, salivation and low A/G ratios were observed at and above 70 mg/kg/day (converted guidance value: 21.8 mg/kg/day), which is within the guidance value range for Category 2; reduced body-weight gain, increased sodium, increased urea nitrogen and triglyceride, increased urine volume, decreased urine specific gravity, changes in urine electrolyte levels, increased kidney and liver weights, regeneration changes in the renal tubular epithelium, etc. were observed at 300 mg/kg/day (converted guidance value: 93.3 mg/kg/day) (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), SIDS (2005)). In addition, it is reported that in a 29-day repeated oral dose toxicity test with rats dosed by gavage, basophilic epithelium with mitotic figures was observed in proximal tubules in the kidney at and above 150 mg/kg/day (converted guidance value: 46.7 mg/kg/day), which is within the guidance value range for Category 2, and that increased kidney and liver weights and centrilobular hepatocyte enlargement (an adaptive response related to the metabolism of the test substance) were observed at 250 mg/kg/day (converted guidance value: 77.8 mg/kg/day) (SIDS (2005)). From the above, although effects were observed in the kidney and liver, the liver was not regarded as a target organ because the effect on the liver was considered to be an adaptive response related to test-substance metabolism. Therefore, this substance was classified in Category 2 (kidney). The classification of this substance was changed as the finding in the liver was considered to be an adaptive response.	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.	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 1	Warning	H400	P273 P391 P501	From 96-hour LC50 = 0.0479 mg/L for crustacea (Americamysis bahia) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 1978)), and 60-day NOEL = 0.0061 mg/L for fish (Oncorhynchus mykiss) (OECD SIDS: 1995), it was classified in Category 1.	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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