GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 3228-02-2
Chemical Name 4-Isopropyl-3-methylphenol
Substance ID R02-A-004-METI, MOE
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/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 for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link)  
Model SDS by MHLW (External link)  
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 classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
7 Flammable solids Classification not possible
-
-
- - No data available.
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.
9 Pyrophoric liquids Not classified (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 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).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
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.
15 Organic peroxides Not classified (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.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) LD50 for mice: > 2,200 mg/kg (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020))
(2) LD50 for mice (males): 6,280 mg/kg (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats (OECD TG402, GLP): > 2,000 mg/kg (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
From (1), no dead animals were seen at 1.41 mg/L within a range for Category 4, but it was technically hard to set a dose near the upper limit for Category 4, and effects at the dose are unclear. Therefore, the classification is not possible.

[Evidence Data]
(1) LC50 for rats (4 hours) (OECD TG403, GLP): > 1.41 mg/L (the maximum possible concentration in the air, measured value) (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 72-hour observation), no skin irritation was seen (erythema/eschar score: 0/0/0, edema score: 0/0/0) (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).

[Reference Data, etc.]
(2) It is reported that in a skin irritation test with rabbits (n = 8) (semi-occlusive, 4-hour application, 72-hour observation), no erythema or edema was found in either an abraded skin group (4 animals) or an intact skin group (4 animals) at either 0.1% solution or 1% solution applied (NICNAS IMAP (2016)).
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
[Rationale for the Classification]
It was classified in Category 1 from (1).

[Evidence Data]
(1) It is reported that in an in-vitro eye irritation test (OECD TG 437), in vitro irritation score (IVIS) was 46.9, 2.3, 95.3 for a group treated with this substance (n = 3, 20% solution of this substance (saline), 2-hour application), a negative control group (n = 3, saline, 2-hour application), and a positive control group (n = 3, 20% solution of imidazole (saline), 2-hour application), respectively. The cut-off value for IVIS for Category 1 is > 55, but because in two samples from the group treated with this substance, upper cloudy layers of the cornea have sloughed, resulting in lower values, and corneal opacity was significantly high in one sample without sloughing, it was reported that if the sloughing were not so severe in the two samples, the overall IVIS would be predicted to be higher, and this substance was determined to cause serious eye damage (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) It is reported that in a maximization test in 27 persons (intradermal administration: 1% solution), low-grade irritation reactions were observed on the sites that were applied with an SLS solution before induction, but no reactions were seen on treated sites without SLS treatment, and there was no skin sensitization (NICNAS IMAP (2016)).
(2) It is reported that in a local lymph node assay (LLNA) with mice (n = 5) (OECD TG 429), irritation index (SI values) was 1.54 (10%), 0.87 (25%), 2.64 (50%), an EC3 value could not be determined, and no skin irritation was seen (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on the data of (1) to (4), it was classified as "Not classified."

[Evidence Data]
(1) In a bacterial reverse mutation assay (OECD TG 471), negative results were reported (NICNAS IMAP (2016)).
(2) In an in vitro mammalian cell gene mutation test (OECD TG 476, MLA), negative results were reported (NICNAS IMAP (2016)).
(3) In a chromosomal aberration test (OECD TG 473, GLP) using cultured human lymphocytes, for continuous treatment in the absence of a metabolic activation system, positive results were reported (while for short-time treatment, regardless of the presence or absence of a metabolic activation system, negative results were reported) (NICNAS IMAP (2016)).
(4) In a micronucleus test (OECD TG 487, GLP) using cultured human lymphocytes, for continuous treatment in the absence of a metabolic activation system, negative results were reported (REACH registration dossier (2014)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 2.

[Evidence Data]
(1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by feeding administration with rats (OECD TG422, GLP, for minimum of five consecutive weeks from two weeks prior to pairing (males), and from two weeks prior to pairing, throughout pairing, during gestation and until day 6 of lactation (females)), lower body weight and food consumption (males and females), reduced heart and ovary weights (females) and lower number of implantations and mean litter size were observed in parental animals at 15,000 ppm, while reduced body weight gain was observed in the offspring (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that in an acute inhalation (dust) toxicity test (OECD TG403, GLP) with rats, at 1.41 mg/L (within the guidance value range for Category 2), increased respiratory rate, hunched posture and pilo-erection were observed and there were isolated cases of red/brown staining to the eyes and/or snout (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
(2) In an acute oral toxicity study and an acute dermal toxicity test with mice, there was no finding that should be adopted as a rationale for the classification (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was considered as "Not classified" in the oral route. However, there was no information on toxicity in the inhalation route, and it was judged as "Classification not possible due to lack of data."

[Evidence Data]
(1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG422, GLP) by feeding administration with rats (for minimum of five consecutive weeks from two weeks prior to pairing (males), and from two weeks prior to pairing, throughout pairing, during gestation and until day 6 of lactation (females)), transient lower body weight and food consumption attributed to the palatability of the feed (males and females) and thymic involution (females) were observed at 15,000 ppm (approximately 1,000 mg/kg/day, converted guidance value: 750 mg/kg/day, in the range corresponding to "Not classified") (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
(2) In a 90-day feeding study with rats, at 2,000 mg/kg/day (in the range corresponding to "Not classified"), lower body weight, decreased motor activity and drowsiness (during the first 15 days of feeding) were reported (NICNAS IMAP (2016), REACH registration dossier (Accessed May 2020)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
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 Short term (Acute) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 48-hour EC50 = 9.23 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
Reliable chronic toxicity data were not obtained. It was classified in Category 2 because it is not rapidly degradable (BIOWIN), and it was classified in Category 2 in acute toxicity.
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.
  • 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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