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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	97-23-4
Chemical Name	2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane; Dichlorophen
Substance ID	24A6075
Classification year (FY)	FY2012
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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
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 applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 700 deg C (GESTIS (Access on Aug. 2012)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not 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	It was classified in Category 4 based on LD50 values for rats of 1,506 mg/kg (males) and 1,683 mg/kg (females) (HSDB (2006)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Not classified	- -	-	-	In a test in which 0.5 mL was applied to the rabbit skin for 24 hours, scores were 1-0 for erythema/eschar and 0 for edema at observation after 24 hours and 72 hours, the primary irritation index (PII) was 0.5, and this substance was judged to be not a primary skin irritant (HSDB (2006)). Therefore, it was classified as "Not classified."
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is described that extreme corneal opacity, severe conjunctival erythema, moderate to extreme edema, blisters under the eyelids, vascularization, mild to severe discharge, bloody discharge, and hair loss around the eye were observed in a test in which 0.1 g was applied to the conjunctival sac of rabbits, and iritis was not scored because of extreme corneal opacity (HSDB (2006)). And also in another eye irritation test in which 0.1mL was applied to the conjunctival sac of rabbits, corneal opacity, iris congestion, and severe conjunctival irritation were found during the observation period of 24 hours to 3 days (HSDB (2006)). From the above results, because severe effects on the eye, especially severe damage in the cornea, occurred, it was classified in Category 1. Besides, it was classified in Xi; R36 in EU classification (EC-JRC (ESIS) (Access on Aug. 2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	This substance is listed as one of contact allergens, and in a patch test in patients with skin lesions such as dermatitis, eruptions, and ulcers, four out of 15 subjects showed positive reactions (HSDB (2006)). There is a case report of a 56-year-old woman with a 10-year history of stasis ulcers who showed severe redness, edema, and vesiculation in a patch test, and there is a case report of a 67-year-old woman with stasis dermatitis and traumatic ulceration that was unhealed for four years had erythema, edema, and blisters in a patch test, which was positive (HSDB (2006)). The above was List 2 information, but because there were multiple case reports in humans, it was classified in Category 1. And skin sensitization tests with guinea pigs gave both positive and negative results (HSDB (2006)). Besides, this substance is listed in the photoallegen series for photo patch testing, and it is reported that 13 people had a positive reaction to this substance in a patch test in 352 subjects with a history suggestive of photosensitivity (HSDB (2006)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, a positive result was obtained in an Ames test (NTP DB (1988)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Data are lacking. Besides, an appreciable proportion of patients treated with this substance developed colic, diarrhea, and nausea, lasting for 4-6 hours, vomiting occurred occasionally, and lassitude was another common symptom (HSDB (2006)). And it is reported that this substance was used to treat 57 patients of infestations with Taenia saginata, Hymenolepis nana, and Ascaris lumbricoides, laxation was observed as a side effect, and 15% of them developed nausea, anorexia, and abdominal colic (HSDB (2006)). However, because it is described that the signs did not require interruption of dosing (HSDB (2006)), these were estimated to be very mild and were not adopted for classification.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 90-day diet administration test with rats, focal interstitial nephritis with tubular nephrosis and dilatation, and eosinophilic casts were observed in the 0.5% group (250 mg/kg bw/day) as changes related to administration of this substance, but these were not seen in the 0.2% group (100 mg/kg bw/day) (HSDB (2006)). The dose with the changes in the kidney exceeded the guidance value range, and because they were not observed at 100 mg/kg/day corresponding to the upper limit of the guidance value range, it corresponds to "Not classified" in oral administration. However, due to no data in the other routes, it was classified as "Classification not possible" for specific target organ toxicity (repeated exposure).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.05 mg/L for crustacea (Spicodiaptomus chilospinus) (HSDB, 2006).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (not readily degradable, BOD 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1983)), and 33-day NOEC = 0.154 mg/L for fish (Pimephales promelas) (AQUIRE, 2012). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (not readily degradable, BOD 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1983)), and 48-hour EC50 = 0.05 mg/L for crustacea (Spicodiaptomus chilospinus) (HSDB, 2006). By drawing a comparison between the above results, it was classified in Category 1.
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.

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