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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	5216-25-1
Chemical Name	p-(Trichloromethyl)chlorobenzene (p-Chlorobenzotrichloride)
Substance ID	H30-B-034-MHLW, MOE
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2007
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)	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	Not classified	- -	-	-	From a flash point of 113 deg C [unknown test methods] (GESTIS (Accessed Nov. 2018)), it is estimated that it will be above 93 deg C also in prescribed closed-cup methods, therefore, it was classified as "Not classified."
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 505 deg C (GESTIS (Accessed Nov. 2018)).
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 chlorine (but not fluorine or oxygen) 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 in the molecule.
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Base on (1)-(5), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 652 mg/kg (male) (DFGOT vol. 10 (1998)) (2) LD50 for rats: 581 mg/kg (female) (DFGOT vol. 10 (1998)) (3) LD50 for rats: 685 mg/kg (DFGOT vol. 10 (1998)) (4) LD50 for rats: 1,350 mg/kg (DFGOT vol. 10 (1998)) (5) LD50 for rats: 572 mg/kg (male, female) (REACH registration dossier (Accessed Dec. 2018))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 1,900 mg/kg (DFGOT vol. 10 (1998))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Liquid (GHS definition)
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)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1), it was classified in Category 4. The category was changed by the use of a new information source. Besides, because the test concentration of 1.48 mg/L (158 ppm) in (1) is higher than the saturated vapor pressure concentration (39.6 ppm), the reference value of a mist was applied. [Evidence Data] (1) LC50 for rats by 4 hours inhalation: 1.48 mg/L (REACH registration dossier (Accessed Dec. 2018)). [Reference Data, etc.] (2) LC50 for rats by inhalation: 0.125 mg/L (exposure time unknown) (DFGOT vol. 10 (1998)).
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] (2) corresponds to "Not classified" (Category 3 in UN GHS classification). As for (1), though the information on 72 hours after patch removal is unknown, it is judged that it is severely irritating. So, Category 2 is considered appropriate. Because both (1) and (2) are highly reliable data, Category 2 with the higher hazard was adopted. [Evidence Data] (1) It was reported that in 4-hour semi-occlusive application in a skin irritation test (OECD TG 404, GLP-compliant, n=3) with rabbits, the erythema score was 1.0 and the edema score was 0.43 at 14-day after patch removal, but scores up to 72 hours after patch removal were not reported. In the test report, it was judged to be severely irritating (REACH registration dossier (Accessed Dec. 2018)). (2) It is reported that in 4-hour occlusive application of a skin irritation test (OECD TG 404, GLP-compliant, n=3) with rabbits, the erythema and edema scores were around 1 at 24, 48 and 72 hours after patch removal but that the erythema score was 1 and the edema score was 0 even after 15 days (REACH registration dossier (Accessed Dec. 2018)). [Reference Data, etc.] (3) It is classified in Skin Irrit. 2 in EU CLP.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1) in which irritation did not disappear within the observation period of 7 days, and based on (2), it was classified in Category 2A. Besides, although there are data of (3), it did not include irritation data up to 72 hours after application, therefore they were not adopted for classification. [Evidence Data] (1) There is a report that in an eye irritation test with rabbits (16 CFR 1500.4 (equivalent to OECD TG405), n=6), after application of this substance of 0.1mL, the calculated average scores at 24, 48 and 72 hours were 1 for corneal opacity, 0 for iritis, 2 for conjunctival redness, and 2 for conjunctival edema, and that conjunctival edema was seen in 4/6 animals even after 8 days (REACH registration dossier (Accessed Dec. 2018), DFGOT vol. 10 (1989)). (2) There is a report that in an eye irritation test with rabbits, this substance is mildly irritating to the conjunctiva (DFGOT vol. 10 (1989)). [Reference Data, etc.] (3) There is a report that in an eye irritation test with rabbits (OECD TG 405, GLP-compliant, n=3), no irritation was observed in all animals after 7 days, however, the score up to 72 hours after application was not shown (REACH registration dossier (Accessed Dec. 2018)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[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. As pointed out by DFGOT, because the test details were unknown, (2) was not adopted for classification. The category was changed by the use of new information sources. [Evidence Data] (1) There is a report that, as a result of applying a 1-10% solution of this substance (4:1 acetone/olive oil) in an LLNA test with mice (OECD TG429, GLP-compliant, n=5/group), the IS value was 7.2, 15.9 and 19.5 for each of the 1, 5 and 10% solutions. This exceeded 3, but the EC3 values could not be calculated (REACH registration dossier (Accessed Dec. 2018)). [Reference Data, etc.] (2) There is a report that a 1% solution of this substance was applied to the skin of experimental animals (animal species unknown) 10 times, and as a result of the challenge by application of a 1% solution after induction, a moderate positive reaction was observed in 60%, the examiner concluded it to be sensitizing to the skin (DFGOT vol. 10 (1989)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There are no in vivo data, therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, positive results are obtained in two bacterial reverse mutation tests (DFGOT vol. 10 (1989), Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law (Accessed Dec. 2018)). (2) In an in vitro mammalian cell gene mutation test (hprt), a positive result was obtained (DFGOT vol. 10 (1989)). (3) In two in vitro mammalian cell chromosome aberration tests, positive results were obtained (DFGOT vol. 10 (1989), Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law (Accessed Dec. 2018)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There are no available reports on human carcinogenicity. Based on (1) and (2), though only one species, malignant tumors were observed in multiple organs through two routes, the oral and dermal, additionally, tumors were generated by shorter period administration than the usual 2 years (104 weeks). Therefore, it was classified in Category 1B. [Evidence Data] (1) Female mice were given 0.05-2 microL of this substance by gavage for 17.5 weeks 2 times/week, and generation of tumors was surveyed after 14 months. As a result, increases in forestomach tumors (squamous cell carcinomas, intraepithelial carcinoma, multiple papillomas) and pulmonary tumors (adenocarcinoma, adenoma) were observed in all dose groups at or above 0.05 microL, increases in malignant lymphoma and thymoma at or above 0.8 microL, and increases in skin cancers (squamous cell carcinoma, sarcoma, adenocarcinoma), breast cancer and salivary gland cancer at 2 microL were observed. Additionally, a dose dependence was observed in the incidence of tumor-bearing animals (DFGOT vol. 10 (1998), REACH registration dossier (Accessed Dec. 2018)). (2) Five microL of this substance dissolved in benzene were dermally applied to female mice for 30 weeks 2 times/week, and tumor generation was surveyed 9 months after the test start. As a result, tumors were observed in 82% (18/22 animals) of the dosed group, of which 16 cases were malignant tumors, 2 cases were benign tumors with malignant tumors accounting for the larger share. As for the site, tumors were observed in the skin, lungs, esophagus, stomach, etc. including metastatic skin tumors (DFGOT vol. 10 (1998)). [Reference Data, etc.] (3) It is classified in Carc. 1B in EU CLP. There are no other classification results by domestic and international organizations.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] (1) shows adverse effects on the testis and sperm, however, there is no data on fertility. In addition, in a developmental toxicity test by inhalation exposure in (2), though developmental effects on the fetus occurred at the dose with apparent maternal toxicity, all of them were mild effects (fetal weight loss, skeletal variations, delayed ossification). Therefore, according to the GHS Classification Guidance for the Japanese Government evidence of classification, it was not adopted as a rationale for the classification. From the above, based on existing findings, no distinct evidence to assign to a category was obtained, so it was classified as "Classification not possible." Besides, as in (3), it is classified in Repr. 2 by the EU, however, the rationale for the classification is not clear. [Evidence Data] (1) In a 90-day oral administration test with rats and a 30-day inhalation exposure test with rats, effects on the testis and sperm (testicular atrophy, downsized testis, aspermatogenesis) were observed (DFGOT vol. 10 (1989)). (2) Pregnant rats were exposed by inhalation at a maximum of 25 mg/m3 on gestation days 6-19. As a result, decreased body weight gain and decreased food consumption were observed in maternal animals at a dose of 25 mg/m3, however, only decreased body weight of fetuses, cervical ribs, and incompletely ossified breastbones were observed in fetuses (DFGOT vol. 10 (1989)). [Reference Data, etc.] (3) It is classified in Repr. 2 in EU CLP.
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs), Category 3 (narcotic effects)	Warning	H371 H336	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] It is possible to classify in Category 2 (respiratory organs) based on (1), and it is possible to classify in Category 3 (narcotic effects) based on (2). Therefore, it was classified in Category 2 (respiratory organs), Category 3 (narcotic effects). The category was changed by the use of a new information source. [Evidence Data] (1) There is a report that in a 4-hour single inhalation exposure test with rats, significant damage to the lungs and upper respiratory tract was observed in addition to eye and skin irritation at 0.99-2.32 mg/L (corresponding within the range of Category 2) (REACH registration dossier (Accessed Dec. 2018)). (2) There is a report in a single dose study by administration orally to rats (OECD TG 401), sedation, hypoactivity, piloerection, hunched posture, hypothermia and salivation were observed at 365-1,230 mg/kg (within the range of Category 2) (REACH registration dossier (Accessed Dec. 2018)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs, genetic organs (men)), Category 2 (haemal system, liver)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] It is possible to classify in Category 1 (respiratory organs, genetic organs (men)) based on (1), and it is possible to classify in Category 2 (hemal system, liver, genetic organs (men)) based on (2). Therefore, it was classified in Category 1 (respiratory organs, genetic organs (men)) and Category 2 (hemal system, liver). As a result of reviewing the data, some target organs were added and the classification was changed. Besides, although there is a report in (3) that symptoms suggesting central nervous system depression were observed, these were not observed in (2) which is a 90-day test. Therefore, the central nervous system was not adopted as a target organ. [Evidence Data] (1) There is a report that in a test in which rats were exposed by inhalation to 3.98-94.5 mg/m3 (estimated as a vapor) for 30 days (6 hours/day, 5 days/week), the respiratory tissue changes (atrophy of the olfactory epithelium, and ulceration, squamous metaplasia and hyperplasia of the respiratory tract epithelium) were observed at 3.98 mg/m3 (converted guidance value: 0.00095 mg/L, within the range of Category 1), testicular atrophy was observed at 94.5 mg/m3 (converted guidance value: 0.032 mg/L, within the range of Category 1) (DFGOT vol.10 (1989)). Besides, the test concentration range of 3.98-94.5 mg/m3 (0.4-10.1 ppm) is less than 90% of the saturated vapor concentration (39.6 ppm) of this substance. Since the test air is considered to be a vapor without a mist, the reference value for a vapor was applied for classification. (2) There is a report that in a test in which rats were dosed by gavage with 12.5-25 mg/kg/day for 90 days (7 days/week), the effect on the blood (decreased leukocyte and lymphocyte counts (male and female), decreased erythrocyte count and hematocrit value (male)), the effect on the male genetic organs (smaller testes, atrophy of the seminal duct, aspermatogenesis) and the effect on the liver (foci of hepatocellular changes (male)) were observed at 12.5 and 25 mg/kg/day (within the range of Category 2) (DFGOT vol. 10 (1989)). [Reference Data, etc.] (3) There is a report that in a test in which rats were dosed by gavage for 2 weeks for dose finding for (2), symptoms suggesting central nervous system depression (tremors, ataxia) in addition to decreased body weight gain, digestive disorders, breathing difficulties, etc. were observed at 25 mg/kg/day (converted guidance value: 3.89 mg/kg/day, within the range of Category 1) (DFGOT vol. 10 (1989)). (4) There is a report that in a test in which rats were exposed by inhalation to this substance at 0.1-9.67 mg/m3 for 4 months, symptoms of pulmonary irritation were observed from 0.1 mg/m3, occurrence of death cases and damage to the lungs, liver and brain were observed at 9.67 mg/m3. However, the description is insufficient, and no control group was designed, so it is considered that the effects are suspicious (DFGOT vol. 10 (1989)). (5) As for a report by the same author as above, in a 4-month inhalation exposure test with guinea pigs, proteinuria, transient decreases in hemoglobin level and leukocyte count were observed at 1.72 mg/m3 (DFGOT vol. 10 (1998)).
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 (Acute)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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