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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	3524-68-3
Chemical Name	Pentaerythritol triacrylate
Substance ID	H30-B-024-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	FY2008
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	- -	-	-	A flash point is 101.5 deg C (closed cup) (GESTIS (Accessed Sept. 2018)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene group) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.
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 oxygen (but not fluorine or chlorine) 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] The data of (1) and (2) are reported as LD50 values for rats, and they are respectively corresponding to Category 4 and "Not classified" (Category 5 in UN GHS classification). By adopting the category with the higher hazard, it was classified in Category 4. [Evidence Data] (1) LD50 value for rats: 1,350 mg/kg (NTP GMM4 (2005)) (2) LD50 value for rats: 2,902 mg/kg (converted from 2.46 mL/kg and density of 1.18 g/mL) (NTP GMM4 (2005))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on the reports of (1) and (2) as LD50 values of rats, it was classified as "Not classified" (corresponding to Category 5 in UN GHS classification or "Not classified"). [Evidence Data] (1) LD50 value for rabbits: >2,000 mg/kg (NTP GMM4 (2005)) (2) LD50 value for rabbits: 4,720 mg/kg (converted from 4 mL/kg and density of 1.18 g/mL) (NTP GMM4 (2005))
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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] It is impossible to use (2) and (3) for classification judgment because the details of these tests are unknown. However, by considering (1) and (4), it seems appropriate to classify this substance as irritating to the skin, therefore it was classified in Category 2. [Evidence Data] (1) There is a report that this substance is irritating (GESTIS (Accessed Sept. 2018)). [Reference Data, etc.] (2) There is a report that, as a result of applying solutions of this substance in acetone to mice and rats, inflammation suggesting skin irritation, ulcers and epidermal degeneration, etc. were observed (GESTIS (Accessed Sept. 2018)). (3) There is a report that as a result of applying the undiluted liquid of this substance to rabbits for 24 hours, mild reddening (2 on a scale of 1 to 10) was observed (GESTIS (Accessed Sept. 2018)). (4) It is classified in Skin Irrit. 2 by EU CLP.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Although the details of the tests in (1) to (4) are unknown, it was considered appropriate to classify this substance as corrosive to the eyes, and it was classified in Category 1. [Evidence Data] (1) There is a report that in an eye irritation test with rabbits, when applying a 1% solution (in water or polyethylene glycol) of this substance, severe corrosivity (10 on a scale of 1 to 10) was observed (GESTIS (Accessed Sept. 2018)). (2) There is a report that in an eye irritation test with rabbits, severe irritation, corrosivity and corneal opacity were observed (NTP GMM4 (2005)). (3) There is a report that in a test with rabbits, severe irritation was observed (NTP GMM4 (2005)). (4) It is described that this substance is corrosive to the eyes (GESTIS (Accessed Sept. 2018)). [Reference Data, etc.] (5) It is classified in Eye Irrit. 2 by EU CLP.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 based on (1) and (2), and because sub-categorization was possible based on (3) and (4), it was classified in Category 1A. Besides, the category was changed from the previous classification by use of new information sources. [Evidence Data] (1) There is a report that when applying a patch of a 10% solution of this substance on the arms of volunteers aged 18-25 years, followed by changing the patch each day to induce sensitization and applying a patch of a 0.1% solution in petrolatum to the back of the subjects 4 weeks later, macular erythema in 1/8 subjects, blisters or edema in 4/8 subjects, severe ulcer in 1/8 subjects were observed (NTP GMM4 (2005)). (2) There are multiple reports which showed positive patch tests in workers handling this substance (NTP GMM4 (2005)). (3) There is a report that in a maximization test with guinea pigs, reactions were observed in 10/15 animals (petrolatum) and 0/15 animals (acetone) at an intradermal dose of 1% (MAK/BAT (1998)). (4) There is a report that in maximization tests with guinea pigs, reactions were observed in 2/5 animals at an intradermal dose of 0.001%, in 8/15 animals at 0.01%, in 13/15 or 4/5 animals at 0.05%, in 8/15 animals at 0.25%, 10/10 animals at 0.5% (MAK/BAT (1998)). [Reference Data, etc.] (5) It is classified in Skin Sens. 1 by EU CLP.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] It is considered that the formation of micronuclei in (2) is one pointer suggesting the in vivo somatic cell mutagenicity of this substance. However, this is a finding in Tg.AC mice for which the oncogene v-Ha-ras was introduced, and they are not animals usually used for classification for this hazard class. In addition, other in-vivo test results are limited to a negative result in (1). Based on the above, it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for in vivo, a micronucleus test with peripheral blood erythrocytes of B6C3F1 mice after 3-month transdermal application of this substance was negative in both males and females (NTP GMM4 (2005)). (2) As for in vivo, in micronucleus tests with peripheral blood erythrocytes after 6 months of transdermal application to transgenic mice (Tg.AC Hemizygous), it was clearly positive in females, and it was not possible to judge positive or negative in males (NTP GMM4 (2005)). (3) Although no signs of myelotoxicity are observed in (1), in (2), an increase in indicators suggesting myelotoxicity and an increase in the immature polychromatic erythrocyte (PCE) ratio in two high dosed groups in both of males and females were observed, implying a stimulation of erythropoiesis in response to myelotoxicity of this substance (NTP GMM4 (2005)). [Reference Data, etc.] (4) As for in vitro, in a bacterial reverse mutation test, a negative result was obtained (NTP GMM4 (2005)). (5) As for in vitro, in a mouse lymphoma test, a positive result was obtained (NTP GMM4 (2005)).
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 this substance in humans. As for experimental animal data, based on (1) and (2), it was proved that tumors developed by stimulating continually on a site of application through the dermal route. In a test with transgenic mice in (1), the development of tumors was limited to the application site. However, in a test with usual mice in (2), there is a report of spleen lymphoma. Based on the above, it is considered that tumorigenic effects due to dermal exposure to this substance may occur systemically. There is no knowledge of carcinogenicity in humans and no information of experimental animals in other routes. However, based on the limited evidence of carcinogenicity in animal tests, Category 2 was judged to be appropriate for this hazard class. Besides, although the same data were used as in the previous classification, the category was changed by revaluation. [Evidence Data] (1) In a carcinogenicity test in which this substance was dermally applied to TG.AC mice at 0.75-12 mg/kg/day for 27 weeks (6 months), an increased incidence of squamous papilloma was observed on the application site of the skin in males and females at or above 3 mg/kg/day, and also squamous cell carcinomas were observed in 2 males at 3 mg/kg/day, in 3 males and 1 female at 12 mg/kg/day. NTP concluded that this substance increased the incidence of squamous papilloma of the skin at the application site of Tg.AC mice and also caused squamous cell carcinoma in males (NTP GMM4(2005), GESTIS (Accessed Sept. 2018)). (2) There are three reports of dermal application tests in which C3H/HeJ male mice were given an application of this substance or mixture containing this substance (all of which were only 1 dose), and in two of these tests, no development of skin tumors was observed. However, there was a report that in a test in which 50 mg of a 5% solution of this substance in white mineral oil was applied dermally for 80 weeks, skin squamous cell carcinoma was observed in 1 of 50 animals, and the development of lymphoma was observed in 6 animals (NTP GMM4 (2005)). (3) There are no classification results by domestic and international organizations.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] The details of conditions and results in (1) data are unknown, and the findings are considered to be inconsistent. On the other hand, because of no information available about effects on fertility and so on, classification was not possible due to lack of data. Besides, RTECS used in the previous classification as evidence of the classification is excluded from the information sources used for the classification because it is impossible to track back to the primary information. Developmental toxicity data listed in RTECS could not be confirmed in the sources listed in List 1-3 in the survey coverage. [Evidence Data] (1) There is a report that in a developmental toxicity test in which 100 mg/kg/day was dermally applied to pregnant rats during the organogenesis period (gestational Day 6-15), mild effects (unknown) were observed in maternal animals, and that uncommon malformations occurred in a small number of fetuses. On the other hand, there is a report that no teratogenicity was observed at the dose where minimal toxicity appeared in maternal animals (NTP GMM4 (2005), GESTIS (Accessed Sept. 2018)).
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] As for the data in (1) and (2), the effects on the hematopoietic tissue or peripheral blood are considered to be secondary effects of skin injury. Based on both test data sets by dermal application, it was impossible to identify the target organs other than the skin irritation effect only at the application site. However, because of no toxicity information on the other routes, classification was not possible due to lack of data. [Evidence Data] (1) In a 6-month dermal application test with Tg, AC hemizygous mice, inflammatory changes (hyperkeratosis, chronic active inflammation, epidermal hyperplasia) as nonneoplastic lesions were observed on the skin of the application site in the dosed group. Also, as systemic effects, hematopoietic cell proliferation in the spleen (male and female) was observed at or above 6 mg/kg/day within the range of Category 1, similarly, hematopoietic cell proliferation in (female) and hematopoietic cell disorder (myelodysplasia) (male) in the liver were observed at 12 mg/kg/day within the range of Category 1 (NTP GMM4 (2005)). (2) In a 14-week dermal application test with F344/N rats and B6C3F1 mice, severe inflammatory changes (epidermal hyperplasia, degeneration, necrosis, chronic active inflammation of the skin, sebaceous gland hyperplasia, hyperkeratosis) were observed at the application site at or above 1.5 mg/kg/day, an increased neutrophil count in rats at or above 1.5 mg/kg/day, an increased neutrophil count and decreased erythrocyte count, hemoglobin, and hematocrit in mice at or above 6 mg/kg/day were observed. These were considered to be secondary effects associated with dermatitis (NTP GMM4 (2005)).
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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