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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	150-76-5
Chemical Name	p-Methoxyphenol
Substance ID	H30-B-026-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	FY2006
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	- -	-	-	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 421 deg C (ICSC (2004)).
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 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 oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	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.

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] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 1,600 mg/kg (ACGIH (1997), PATTY (6th, 2012)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" (Category 5 in UN GHS classification or equivalent to "Not classified"). [Evidence Data] (1) LD50 for rats: >2,000 mg/kg (OECD TG423) (NICNAS IMAP (2018), REACH registration dossier (Accessed Oct. 2018)) (2) LD50 for rabbits: >2,000 mg/kg (NICNAS IMAP (2018), REACH registration dossier (Accessed Oct. 2018))
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (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)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on data in (1) according to the guidelines and GLP-compliance, as irritation scores and findings (slightly), it was classified as "Not classified" (Category 3 in UN GHS classification). Besides, the test details in (2) and (4) were unknown, and as for (3), in addition to this, the test period was inappropriate, therefore, they were not adopted. The category was changed by adopting new information sources. [Evidence Data] (1) There is a report that it was slightly irritating (erythema score: 1.78, edema score: 1.44) in a skin irritation test (OECD Guideline 404, GLP-compliant, semi-occlusive, 4 hours) with rabbits (n=3) (REACH registration dossier (Accessed Oct. 2018), NICNAS IMAP (Accessed Oct. 2018)). [Reference Data, etc.] (2) There is a report that in a study with rabbits, when a 10% solution of this substance (suntan lotion) was applied to the skin, erythema and scarification occurred (PATTY (6th, 2012)). (3) There is a report that in a study with rabbits, severe burns and necrosis were caused when the undiluted liquid of this substance was applied for more than one day (PATTY (6th, 2012)). (4) There is a description that this substance is irritating to the skin (HSDB (2015)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1), it was classified in Category 2B. Besides, the category was changed by adopting a new information source. [Evidence Data] (1) There is a report that in an eye irritation test with rabbits (n=3/sex), slight to moderate conjunctival irritation (6/6 animals), corneal opacity (1/6 animals), corneal ulceration (5/6 animals), and iridial changes (2/6 animals) occurred but these resolved in 7 days (NICNAS IMAP (Accessed Oct. 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) and (2), it was classified in Category 1. Besides, the category was changed by adopting new information sources. [Evidence Data] (1) There is a report that in a sensitization test (OECD TG 406) with guinea pigs (n=10), when a 6.2% solution (peanut oil) of this substance was administered intradermally, 50% responded (NICNAS IMAP (Accessed Oct. 2018), REACH registration dossier (Accessed Oct. 2018), J. Am. Col. Toxicol., 4, 31-63.(1985)). (2) There is a report that in a sensitization test (Freund's complete adjuvant test) with guinea pigs (n=8), when a 3.9% aqueous solution of this substance was administered intradermally, 50% responded (NICNAS IMAP (Accessed Oct. 2018), REACH registration dossier (Accessed Oct. 2018), J. Am. Col. Toxicol., 4, 31-63.(1985)). [Reference Data, etc.] (3) There are reports that no sensitization was observed in multiple human repeated insult patch tests (HRIPT, n=50-51) by nail products containing this substance, but the content of this substance is unknown (NICNAS IMAP (Accessed Oct. 2018), Cosmetic Ingredient Review (CIR) Expert Panel Report (2015)). (4) It was classified as "Skin Sens. 1" in EU CLP.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Evidence Data] (1) As for in vivo, there is a description that no genotoxicity was observed after 6-month dermal application of up to 40 mg/kg/day to rats, but details are unknown (Cosmetic Ingredient Review (CIR) Expert Panel Report (2015)). (2) As for in vitro, there are reports that it was negative in bacterial reverse mutation tests (J. Am Coll. Toxicol., 4 (1985)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] As for carcinogenicity, there are no available reports on humans. In (1), a high incidence of malignant tumors was observed in the forestomach after oral administration to rats, and preneoplastic lesions were observed even at low doses. It is evidence of carcinogenicity is only one species, and considering the situation in (2), it was classified in Category 2. [Evidence Data] (1) When administering this substance at 20,000 ppm by feeding to rats (n=26 (male), 20 (female)) for 2 years, papillomas (50% of males and 23% of females) or squamous cell carcinomas (77% of males and 20% of females) were observed in the forestomach. Also, when the dose was reduced to 4,000 ppm, and administered by feeding for 2 years, papillary or nodular hyperplasia was observed in the forestomach, but no increase in an incidence of tumors was observed (NICNAS IMAP (Accessed Oct. 2018), Cosmetic Ingredient Review (CIR) Expert Panel Report (2015)). (2) There are no classification results by domestic and international organizations. [Reference Data, etc.] (3) As for the medium-term carcinogenicity study, there is a report that an increased incidence of papillomas in the forestomach was observed when dietary administration of this substance at 4,000 ppm for 24-26 weeks after initiator (N-nitrosodiethylamine, etc.) treatment to rats (CIR Expert Panel (2014)). (4) There is a report that compared with the group treated with an initiator alone (MNNG: N-methyl-N'-nitro-N-nitrosoguanidine), no increase in an incidence of forestomach tumors was observed in the combined administration group in which this substance was administered to rats by feeding at max 20,000 ppm for 51 weeks after the treatment with the initiator (CIR Expert Panel (2014)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on reproductive toxicity data on the product of this substance in (1), difficulty in delivery in maternal animals, and increased mortality after birth and growth inhibition, etc. in pups were observed at doses where skin symptoms were observed in maternal animals. In maternal animals, there is no description of systemic toxicity other than skin symptoms and vocalization. Therefore, since delivery impairment and adverse effects on survival rate and growth of offspring were observed in maternal animals in the situation where general toxic effects in maternal animals were not clear, it was classified in Category 2. [Evidence Data] (1) In a study in which a product containing 2% of this substance was administered dermally at 12-120 mg/kg/day as doses of a converted value equivalent to this substance throughout the gestation period of rats, skin irritation symptoms (reddening, thickening and scabbing of the skin) in all F0 treated groups, vocalization at or above 40 mg/kg/day, non-delivery up to post-mating day 25 in 6 females each in the 40 and 120 mg/kg/day groups, and decreased body weight gain and total litter loss up to day 5 of lactation in 4 females at 120 mg/kg/day were observed. In the F1 generation, increased mortality, decreased body weight and symptoms (hypoactivity, paleness, cold sense on contact) were observed in the offspring group born from maternal animals in the 120 mg/kg/day group, which were findings at doses where significant toxicity was manifested in the maternal animals (CIR Expert Panel (2014)). [Reference Data, etc.] (2) There are reports that in developmental toxicity tests in which a product containing 2% of this substance was administered dermally to pregnant rats or rabbits, no malformation was observed at up to 80 mg/kg/day in rats, and up to 40 mg/kg/day in rabbits (CIR Expert Panel (2014)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on data in (1) and (2), through oral exposure, there were no effects corresponding to category from oral administration studies of experimental animals, and from data in (3), through dermal exposure, only local effects and no systemic effects were observed, therefore, classification was not possible from available information. [Evidence Data] (1) In a 5-7-week test with rats dosed by feeding (200-50,000 ppm), decreased body weight gain was observed in males at 1,000 ppm or higher and females at 5,000 ppm or higher, but this is considered to be an effect of decreased palatability by this substance in the diet, and no tissue changes were observed in the organs in the groups treated with up to 50,000 ppm (J. Am. Col. Toxicol., 4, 31-63. (1985)). (2) In a 5-9-week test with rabbits dosed by feeding (up to 100,000 ppm), decreased body weight was observed but no tissue changes were observed in the organs at the highest dose (J. Am. Col. Toxicol., 4, 31-63. (1985)). (3) It is reported in dermal application tests that the black skin of guinea pigs was depigmented, and that necrosis occurred in the skin of rabbits (PATTY (6th, 2012), ACGIH (7th, 2001)). [Reference Data, etc.] (4) There is a report that white skin due to excessive skin depigmentation was observed in 2 of 8 workers occupationally exposed to this substance (ACGIH (7th, 2001), PATTY (6th, 2012)).
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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 (immobile) = 2.2 mg/L for crustacea (Daphnia magna) (NLM HSDB: 2018, EPA/OPPT).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	Chronic toxicity data were not obtained. It was classified as "Not classified" due to rapid degradability (readily biodegradable, an average degradation rate by BOD: 86% (J-CHECK, 1990)), and no bioaccumulation (LogKow: 1.58 (PHYSPROP Database: 2018)).
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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