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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	131-11-3
Chemical Name	Dimethyl phthalate
Substance ID	25B0035
Classification year (FY)	FY2013
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 by the Japanese Government (July, 2013)
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 146 deg C (closed cup) (HSDB (Access on September 2013)) above 93 deg C, it was classified as "Not classified."
7	Flammable solid	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 490 deg C (HSDB (Access on September 2013)).
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)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 values for rats of 6.8 g/kg (ACGIH (7th, 2006)), 8,200 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), PATTY (6th, 2012)), and 8,400 mg/kg (NTP TR429 (1995)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 values for rabbits of >= 10,000 mg/kg (NTP TR429 (1995)) and > 10 mL/kg (converted value: 11.9 g/kg) (ACGIH (7th, 2006), PATTY (6th, 2012)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (Category 3 in UN GHS classification) because it is described that no skin irritation was observed in a test in which this substance was repeatedly applied to rabbit skin for 90 days (ACGIH (7th, 2006), PATTY (6th, 2012)), and no skin irritation is reported in humans (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), ACGIH (7th, 2006)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was classified in Category 2B because no corneal injury or iridial inflammation was seen in an eye irritation/corrosion test with three rabbits (according to EEC Directive 79/831/EEC and OECD TG 405), but only slight conjunctival irritation was observed in 3/3 animals, and the animals fully recovered within 2-3 days after application (IUCLID (2000)).
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	In IUCLID (2000), there is a report on five patch tests in humans, all of which gave negative results, but the details are unknown. It is described that sensitization is not reported in humans (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), ACGIH (7th, 2006)), but no animal test data are available to deny sensitization. Based on the above information, it was classified as "Classification not possible" because data are lacking to classify it as "Not classified."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in dominant lethal tests with mice and rats (ACGIH (7th, 2006), IRIS (2012), IUCLID (2000)) and negative in micronucleus tests with bone marrow erythrocytes of rats and mice (NTP DB (Access on September 2013)) and chromosomal aberration tests with rats and mice (IUCLID (2000)). As for in vitro, most of the bacterial reverse mutation tests were negative (ACGIH (7th, 2006), NTP DB (Access on September 2013), NTP TR429 (1995), IUCLID (2000)), and it was positive in a mouse lymphoma test with cultured mammalian cells (ACGIH (7th, 2006), IRIS (1990), IUCLID (2000)) and negative in a chromosomal aberration test with cultured mammalian cells (ACGIH (7th, 2006), NTP DB (Access on September 2013), NTP TR429 (1995), IUCLID (2000)).
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it is classified in D by EPA (IRIS (1990)). The category was changed according to the GHS classification guidance for the Japanese government.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for developmental toxicity, it is described that in a test with rats by diet administration during gestation, no developmental toxicity was observed even at the dose where general toxicity was seen in maternal animals (Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), ACGIH (7th, 2006), NTP TR429 (1995), NTP DB (Access on September 2013)), and in a diet administration test with mice, no fetal abnormalities were found at the doses that produced general toxicity in maternal animals (ACGIH (7th, 2006), NTP TR429 (1995)). However, because of no information on fertility, it was classified as "Classification not possible" due to lack of data. The information source in List 3 was deleted, and the information source in List 1 was added.
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	It was judged to cause narcotic effects from the descriptions in the Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), ACGIH (7th, 2006), and NTP TR429 (1995) that ingestion causes coma in humans, and it was classified in Category 3 (narcotic effects). Furthermore, it was classified in Category 3 (respiratory tract irritation) because it is described that it is irritating to the respiratory tract in humans (ACGIH (7th, 2006)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 33-day dermal exposure test with rabbits, no toxicity effects were observed even after application of the dose (converted guidance value: 1,750 mg/kg/day) above the range for Category 2 (ACGIH (7th, 2006)). Therefore, it falls under "Not classified" in the dermal route. However, because of no toxicity information on the other routes, the classification is not possible due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	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 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 29 mg/L for fish (Cyprinodon variegatus) (Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002); ECETOC TR91, 2003).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 93% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1989)), and 21-day NOEC = 9.6 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002); ECETOC TR91, 2003). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, there are data: 96-hour EC50 = 54 mg/L for algae (Gymnodinium breve) (Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002)). However, it is rapidly degradable (a degradation rate by BOD: 93% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1989)), and low bioaccumulation is estimated (log Kow = 1.60 (HSDB, 2013)). Therefore, it is classified as "Not classified." From the above results, it was classified as "Not classified."
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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