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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	8050-09-7
Chemical Name	Rosin
Substance ID	R03-B-005-MHLW
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2009 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 (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)	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 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. Besides, there is information that it is combustible (ICSC (2004)).
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] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 2,800 mg/kg (REACH registration dossier (Accessed Oct. 2021), AICIS IMAP (2013)) (2) LD50 for rats: 8,400 mg/kg (IPCS (1996), US EPA (2005))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 402, GLP) (AICIS IMAP (2013), REACH registration dossier (Accessed Oct. 2021))
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] Classification not possible due to lack of data. Besides, since the references used for the previous classification was not included in the information source list of the current guidance, it was not adopted. Accordingly, the classification result was changed.
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in an acute dermal irritation/corrosion test (OECD TG 404, GLP, semiocclusive, 4-hour application, observation for 72 hours) with rabbits (n=3), no erythema or edema was observed at the 24, 48 or 72-hour observation (AICIS IMAP (2013), REACH registration dossier (Accessed Oct. 2021)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test (OECD TG 405, GLP, observation for 21 days) with rabbits (n=3), slight eye irritation was observed (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 1.3/0.7/0.7, chemosis score: 1.3/0.3/0.3) (AICIS IMAP (2013), REACH registration dossier (Accessed Oct. 2021)). [Reference Data, etc.] (2) The ACGIH set the threshold limit value (TLV-TWA) in a work environment at 0.001 mg/m3 to protect non-sensitized workers from respiratory and eye irritation (ACGIH (8th, 2020)).
4	Respiratory sensitization	Category 1A	Danger	H334	P304+P340 P342+P311 P261 P284 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) The Japan Society For Occupational Health (JSOH) classified Colophonium (Rosin) in occupational sensitizers to the respiratory tract Group 1. (2) There are many epidemiological study reports and case reports on the symptoms, such as asthma, wheezing, and shortness of breath, related to the administration of this substance (ACGIH (8th, 2020)).
4	Skin sensitization	Category 1A	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 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) The Japan Society For Occupational Health (JSOH) classified Colophonium (Rosin) in occupational sensitizers to the skin Group 1. (2) There are multiple case reports on the allergic dermatitis caused by this substance (ACGIH (8th, 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] There was no in vivo test data available, but all the standard combined in vitro test results were negative in (1). Therefore, it was classified as "Not classified." [Evidence Data] (1) As for in vitro tests, a bacterial reverse mutation test (OECD TG 471, GLP), a vitro mammalian chromosomal aberration test using the human lymphocytes (OECD TG 473, GLP), and an in vitro mammalian cell gene mutation test using the L5178Y mouse lymphoma cell line (OECD TG 476, GLP) were conducted and all the results were negative (REACH registration dossier (Accessed Sep. 2021), AICIS IMAP (2013)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was reported that, in a 2-year chronic toxicity/carcinogenicity study using wood rosin (CAS RN -) as a test substance with rats dosed by feeding, no increase in the incidence of tumors was observed at up to 1% (10,000 ppm: corresponding to 434 mg/kg/day) (JECFA FAS 35 (1996), EPA (2005), Canada CMP Screening Assessment (2019)), but the study did not meet the requirements for carcinogenicity test, such as the small number of cases (25 to 30 animals/sex/group).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 since reproduction/developmental effects were observed at doses at which general toxicity effects were observed in parental animals. It was classified based on the new information source. [Evidence Data] (1) In two combined repeated dose toxicity studies with the reproduction/developmental toxicity screening test (OECD TG422, GLP) with rats dosed by feeding, at the highest concentration level (10,000 ppm) at which apparent general toxicity effects (lower body weight and food consumption, etc.) were observed in male and female parental animals, decreases in the number of corpora lutea and the number of implantations in female parental animals, and reduced litter size, an increase in postnatal death, and lower body weight in pups were observed. It was reported that the NOAELs for maternal toxicity and developmental toxicity were concluded to be 2,500 ppm and 5,000 ppm, respectively (REACH registration dossier (Accessed Sep. 2021)). (2) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG422, GLP) with other rats dosed by feeding, at the highest concentration level (10,000 ppm) at which apparent general toxicity effects (lower body weight and food consumption, etc.) were observed in male and female parental animals, a slight decrease in the number of corpora lutea in female parental animals and lower body weight in pups were observed. It was reported that the NOAELs for maternal toxicity and developmental toxicity were concluded to be 5,000 ppm and 10,000 ppm, respectively (REACH registration dossier (Accessed Sep. 2021)). (3) In a reproduction/developmental toxicity screening test (OECD TG421, GLP) with rats dosed by feeding, at 10,000 ppm at which reduced body weight gain and decreased food consumption were observed in male and female parental animals, a decrease in the number of implantations in female parental animals and a slight reduction in litter size in pups were observed. It was reported that the NOAELs for maternal toxicity and developmental toxicity were concluded to be 3,000 ppm, respectively (REACH registration dossier (Accessed Sep. 2021), AICIS IMAP (2013)). (4) In a prenatal developmental toxicity study (OECD TG414, GLP, days 3 to 19 of gestation) with female rats dosed by feeding, at the highest dose (7,500 ppm) at which reduced body weight gain and decreased food consumption were observed in parental animals, a decrease in placental weight and lower fetal weight were observed. It was reported that the NOAELs for maternal toxicity and developmental toxicity were concluded to be 2,500 ppm and 5,000 ppm, respectively (REACH registration dossier (Accessed Oct. 2021), Canada CMP Screening Assessment (2019)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3 (respiratory tract irritation) since it was reported to be irritating to the respiratory organs. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) A study on workers' exposures in a factory manufacturing flux-cored solder containing rosin was conducted. As a result of pulmonary function measurements, there was a 21% prevalence of occupational asthma in the workers exposed to rosin at median values of 0.02 mg/m3 (6 workers) and 1.92 mg/m3 (14 workers). But there was only a 4% prevalence of occupational asthma in the workers exposed to less than 0.01 mg/m3, and it was reported to be irritating to the respiratory organs (ACGIH (2020)). [Reference Data, etc.] (2) It was reported that, in an acute dermal toxicity test (OECD TG 402, GLP, 24 hours) with rats, slight to moderate skin dryness was observed at 2,000 mg/kg (within the range for Category 2) (AICIS IMAP (2013), REACH registration dossier (Accessed Oct. 2021)). (3) It was reported that, in an acute oral toxicity test with rats, no effects were observed. Also, the LD50 was reported to be 2,800 mg/kg (REACH registration dossier (Accessed Oct. 2021)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data in the other routes. Besides, the adrenal gland was not adopted as a target organ since the effects in (1) were not observed in the tests at higher doses in (2) and (3). [Evidence Data] (1) It was reported that, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG422, GLP, for 50 days from day 14 of pre-pairing (males), minimum 5 weeks from day 14 of pre-pairing until day 4 of lactation (females)) with rats dosed by feeding, a slightly lower body weight gain, an increase in creatinine, and hypertrophy/vacuolation of the zona glomerulosa in the adrenal glands (males) were observed at 2,500 ppm (converted guidance value: 69.4 mg/kg/day, within the range for Category 2) (REACH registration dossier (Accessed Oct. 2021)). (2) It was reported that, in a reproduction/developmental toxicity screening test (OECD TG421, GLP, for 30 days from day 14 of pre-mating (males), for up to 45 days from day 14 of pre-mating (females)) with rats dosed by feeding, a decrease in body weight gain (males) was observed at 3,000 ppm (converted guidance value: 50 mg/kg/day, within the range for Category 2) (REACH registration dossier (Accessed Oct. 2021)). (3) It was reported that, in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, a decrease in body weight gain, lower food consumption, and increased liver weight (females) were observed at 10,000 ppm (440 mg/kg/day, in the range corresponding to "Not classified") (JECFA FAS 35 (1996), EPA (2005), Canada CMP (2019)).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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