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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	120-32-1
Chemical Name	2-Benzyl-4-chlorophenol; Clorofene
Substance ID	R01-A-003
Classification year (FY)	FY2019
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)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	No data available.
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because 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	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2) in assessment documents in List 1 or equivalent, it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 2,800 mg/kg (NTP TR424 (1994)) (2) LD50 for rats: 3,852 mg/kg (ECHA RAC Background Document (2015)) [Reference Data, etc.] (3) LD50 for rats: 1,700 mg/kg (HSDB (Access on May 2019))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: >2,000 mg/kg (ECHA RAC Background Document (2015))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LC50 for rats (4 hours, aerosol): 2.43 mg/L (ECHA RAC Background Document (2015), REACH registration dossier (Access on June 2019))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) In a skin irritation test with rabbits according to OECD TG 404, the average scores at 24-72 hours in 3 animals were 2.7-3.0 for erythema and 4 for edema, and on Day 14, the score was 0 in all animals. However, scar-like tissue was observed after 21 days, but apparent reversibility was reported (REACH registration dossier (Access on June 2019)). [Reference Data, etc.] (2) It was classified as "Skin Irrit. 2 (H315)" in the EU CLP classification (EU CLP classification (Access on June 2019)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) In an eye irritation test with rabbits according to the OECD TG 405, the average scores at 24-72 hours in 3 animals were reported to be 2.67-3.0 for corneal opacity, 0.67-1.0 for the iris, 2.67 for conjunctival redness, and 1.3-2.0 for conjunctival chemosis. Responses of all animals were reported to be not reversible (REACH registration dossier (Access on June 2019)). [Reference Data, etc.] (2) It was classified as "Eye Dam. 1 (H318)" in the EU CLP classification (EU CLP classification (Access on June 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] It was judged that there was positive indication of sensitization at 24, 48, 72 hours after the challenge in a Buehler test with guinea pigs. The positive rate was not mentioned (REACH registration dossier (Access on June 2019)). [Reference Data, etc.] (2) It was classified as "Skin Sens. 1 (H317)" in the EU CLP classification (EU CLP classification (Access on June 2019)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] According to (1) and (2), based on the weight of the evidence, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, it was negative in a micronucleus test with mouse bone marrow, a dominant lethal test with mice by intraperitoneal administration, and a mouse comet test (liver, glandular stomach, bone marrow) (EPA Pesticide (1995), CLH Report (2014)). (2) As for in vitro, it was positive in a mouse lymphoma TK test and gene mutation test with human lymphoblast cell line TK6, and negative in a mammalian cell chromosome aberration test and bacterial reverse mutation tests (NTP TR424 (1994), NTP TR444 (1995), EPA Pesticide (1995), NTP DB (Access on May 2019), CLH Report (2014)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as Group C by EPA (1995), and in Carc. 2 in the EU CLP (EU CLP classification (Access on May 2019)). [Reference Data, etc.] (2) In a 2-year carcinogenicity test with rats administered by gavage, renal transitional cell carcinomas were observed in females (equivocal evidence) (NTP TR424 (1994), CLH report (2014), ECHA RAC Background Document (2015)). (3) In a 2-year carcinogenicity test with mice administered by gavage, renal tubule tumors were observed in males (some evidence) (NTP TR424 (1994), CLH report (2014), ECHA RAC Background Document (2015)). (4) In a 20-week carcinogenicity test with transgenic mice (Tg. AC female mice) by dermal application, skin tumors were observed (CLH report (2014), ECHA RAC Background Document (2015)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), since effects on the reproductive indexes and developmental indexes in pups were seen at the doses where parental toxicity was observed, it was classified in Category 2. [Evidence Data] (1) In a two-generation reproductive toxicity test with rats administered by gavage (OECD TG 416), lower female fertility indexes were observed in P and F1 generations at the doses where effects on body weight and kidney (nephropathy, dilated tubules, basophilic tubules, etc.) were seen in parental animals. In addition, longer estrous cycle length and reduced fecundity were observed in F1 maternal animals. Regarding the toxicity in pups, decreased terminal body weight was seen in the F1 litter and F2 litter. Moreover, a lower percentage achievement of ear and eye opening and incisor eruption was found in F1 and F2 generations (ECHA RAC Background document (2015), CLH Report (2014)). [Reference Data, etc.] (2) In a developmental toxicity test with female rabbits administered by gavage on Day 6-19 of gestation, no significant effects were observed (EPA Pesticide (1995), ECHA RAC Background document (2015), CLH Report (2014)). (3) In a developmental toxicity test with female rats administered by gavage on Day 6-15 of gestation, slight effects on fetuses (reduced body weight, increased unossification) were observed at the doses where maternal toxicity (death (3/25 animals), etc.) was observed (EPA Pesticide (1995), ECHA RAC Background document (2015), CLH Report (2014)). (4) In a developmental toxicity test with female rats administered by gavage on Day 6-15 of gestation, reduced body weight and reduced food consumptions were observed in maternal animals, but no effects were observed in fetuses (ECHA RAC Background document (2015), CLH Report (2014)). (5) It was classified in Repr. 2 in the EU CLP.
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] According to (1), as effects on the lung were observed in experimental animals at the dose within the range of Category 2, it was classified in Category 2 (respiratory organs). Regarding the information in humans in (2), the number of exposures and the route were unknown, and the target organ could not be identified from the results of the oral administration test in experimental animals in (3), therefore, these were not adopted as evidence of the classification. [Evidence Data] (1) In a 4-hour acute inhalation test (OECD TG 403 compliant) with rats using the aerosol of this substance, decreased motor activity, ataxia, bradypnea, gasping, hyperpnea, abnormal breath sounds were seen at or above 2.07 mg/L (corresponding to Category 2). In the necropsy of dead animals, incomplete collapse and congestion of the lungs were observed. In addition, increased lung weights were observed in the dead animals, which were considered to indicate acute respiratory failure due to pulmonary edema, together with the findings of lung irritation and edema (ECHA RAC Background Document (2015), REACH registration dossier (Access on June 2019)). [Reference Data, etc.] (2) Though the number of exposure and the route were unknown, sweating, thirst, nausea, diarrhea, abdominal pain, hyperactivity, convulsions or stupor, low blood pressure, and dyspnea were observed in patients overexposed to this substance (NTP TR424 (1994)). (3) In a single oral dose test in which rats and mice were dosed at 250, 500, 1,000, and 4,000 mg/kg with this substance, there was no description of the minimum dose in which effects were observed, but the compound-related effects of diarrhea, piloerection, hypoactivity and hyperactivity were observed. No gross lesions were observed at necropsy. Dead animals were found at or above 1,000 in rats and at 4,000 mg/kg in mice (HSDB (Access on May 2019)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (kidney)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), since the effects on the kidney were observed within the range of Category 1 for dermal application to rabbits and within the range of Category 2 for oral administration to rats, it was classified in Category 1 (kidney). [Evidence Data] (1) In a test in which rabbits were dermally applied at 10-160 mg/kg/day for 3 weeks, effects on the kidney (tubular calcinosis, tubular proliferation and cellular infiltration) were observed in females at or above 40 mg/kg/day (converted guidance value: 9.3 mg/kg/day, within the range of Category 1) (ECHA RAC Background Document (2015)). (2) In a 2-year combined chronic toxicity/carcinogenicity study (oral) with rats, increased severity of nephropathy, increased urinary protein and ALP, and increased kidney weight were seen in males at 30 or 60 mg/kg/day (within the range of Category 2), and hyperplasia of renal tubules and hyperplasia of renal transitional epithelial cells, etc. were observed at or above 120 mg/kg/day (exceeding Category 2) (NTP TR424 (1994), EPA Pesticide (1995)).
10	Aspiration hazard	*	- -	-	-	[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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.33 mg/L for fish (Lepomis macrochirus) (U.S. EPA: RED, 1995).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and it was classified in Category 1 in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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