NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	85-44-9
Chemical Name	Phthalic anhydride
Substance ID	m-nite-85-44-9_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Classification not possible	- -	-	-	It is described in ICSC (2003) that it is combustible, but the classification is not possible due to no data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 570 deg C (ICSC (2003)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available. Besides, there is information that stainless steel and aluminum are resistant (Hommel (1991)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	There are 9 reports of LD50 values of 800-1,600 mg/kg (ACGIH (7th, 2014), NTP TR159 (1979)), 800-4,020 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), 1,530 mg/kg (4 cases) (CICAD 75 (2009), DFGOT vol. 25 (2009), SIDS (2006), Environmental Risk Assessment for Chemical Substances Vol.2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)), 2,000 mg/kg (DFGOT vol. 25 (2009)), and 4,020 mg/kg (2 cases) (DFGOT vol. 25 (2009), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998), NTP TR159 (1979)) for rats. It was classified in Category 4 to which the larger number of values corresponded.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of > 10,000 mg/kg (DFGOT vol. 25 (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998)) for rabbits, it was classified as "Not classified."	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there was a report of an LC50 value (one hour) of > 0.21 mg/L (converted 4-hour equivalent value: > 0.0525 mg/L) (DFGOT vol. 25 (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2006), Environmental Risk Assessment for Chemical Substances Vol.2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998)) for rats, the category could not be specified with this data only. Besides, it is described in SIDS (2006) that since these data are old, and the number of animals was small, the reliability was low (Reliability 4). Since the LC50 value was higher than the saturated vapor concentration (0.017 mg/L), the reference value as a dust was applied.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Not classified	- -	-	-	There are two reports from tests according to the test guideline (OECD TG 404), and in the first report, this substance was slightly irritating with average skin irritation index of 1.21 (SIDS (2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and it is reported in the second one that because no irritation reaction was observed, it was not irritating (SIDS (2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, on the basis that it is reported that skin Irritation Index (PII) was 1.5, and it was slightly irritating when 500 mg of this substance moistened with water was applied semi-occlusively to the skin of rabbits for 24 hours (SIDS (2006)), it was classified as "Not classified" (equivalent to Category 3 in UN GHS classification) in JIS classification criteria. Besides, although there was a description of strong irritation to the human skin (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), it is described in SIDS (2006) that effects of occupational exposure in humans were considered to be due to impurities contained in technical grade of this substance (SIDS (2006)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a report that in a test in which 50 mg of undiluted test substance was applied to the conjunctival sac of rabbits, although irritation was observed in the cornea, iris and conjunctiva, all except for the conjunctival redness resolved within a 7-day observation period and it was moderately irritating (SIDS (2006)). In addition, in a test where 100 mg of undiluted test substance was applied to rabbit eyes, the mean score (equivalent to AOI) was 59.2 at 24 hours, and it was judged to be irritating (SIDS (2006)). Based on the above irritation score and a description of moderate irritation, it was classified in Category 2A. Besides, this substance was classified in "Xi:R42" in EU DSD classification, and in "Eye Dam 1 H318" in EU CLP classification.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Category 1A	Danger	H334	P304+P340 P342+P311 P261 P284 P501	This substance was classified as an occupational sensitizer to the airway Group 1 by Japan Society For Occupational Health (JSOH), and as RSEN (Respiratory Sensitizer) in ACGIH (7th, 2013) (Recommendation of Occupational Exposure Limits (2014), ACGIH (7th, 2013)). In addition, there is a description that since the first case of asthma and allergic rhinitis was reported in 1939, it has been known as a respiratory sensitizer (SIDS (2006)). There are multiple reports of asthma in workers handling this substance, there was a report of chronic bronchitis in 13 (11%) and asthma in 21 (18%) in an epidemiological study of 118 workers (SIDS (2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), DFGOT vol. 11 (1998)), and there was a report that asthma in 5 and chronic bronchitis in 6 were observed in a survey of 35 workers engaged at an alkyd resin manufacturing plant (SIDS (2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above results, it was judged to be Category 1A.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	There is a report that in a maximization test (OECD TG 406) with guinea pigs, the positive rate was 90% (SIDS (2006)). In addition, since positive results were obtained in many tests such as a Buehler test with guinea pigs and a local lymph node test (LLNA test) with mice, this substance was judged to be sensitizing (SIDS (2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Also, in humans, there is a report that in a patch test conducted on 191 workers handling this substance, allergic reactions were observed in 14% workers (SIDS (2006)). In addition, this substance was classified as SEN in DFGOT vol. 25 (2009) and as DSEN in ACGIH (7th, 2013) (DFGOT vol. 25 (2009), ACGIH (7th, 2013)). From the above results, it was judged to be Category 1.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is no in vivo data. As for in vitro, it was negative in bacterial reverse mutation tests, a chromosome aberration test and a sister chromatid exchange test with cultured mammalian cells, and positive in a mouse lymphoma test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2014), SIDS (2006), NTP DB (Access on October 2014), CICAD 75 (2009), DFGOT vol. 25 (2009)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	Since it was classified in A4 by ACGIH (ACGIH (7th, 2014)), it was classified as "Classification not possible."	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. In the previous classification, it is described that "From the description of Environmental Risk Assessment for Chemical Substances Vol.2 (Ministry of the Environment, 2003), although there was no description of general toxicity in maternal animals, effects on sperm production, and the testes and epididymis were observed. Therefore, it was classified in Category 2." Although evidence data is from a 45-day inhalation exposure study with male rats, it is described in SIDS (2006) that its poor reporting limits the evaluation of the results. In addition, since only male genetic organs were examined, it was not used for classification. Besides, it is not this substance, but slight effects on the fetuses (delayed ossification of the caudal vertebrae) were reported at an extremely high dose (3,000 mg/kg/day) where maternal toxicity (decreased body weight gain) was observed in a teratogenicity test in which phthalic acid was administered by feeding to pregnant rats (SIDS (2006)).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 3 (respiratory tract irritation, narcotic effects)	Warning	H335 H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	This substance was irritating to the respiratory tract (Environmental Risk Assessment for Chemical Substances Vol.2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003), ACGIH (7th, 2014), CICAD 75 (2009), DFGOT vol. 25 (2009), SIDS (2006)). In humans, airway dysfunction by inhalation exposure to high concentrations of the gaseous substances was reported (OEL Documentations (Japan Society For Occupational Health (JSOH), 1998)). Also, headache, dizziness, nausea, epigastric burning and a feeling of suffocation on inhalation exposure to the dust, etc. were reported (SIDS (2006)). In experimental animals, there was a report of sedation and imbalance at the oral dose of 500 mg/kg (SIDS (2006)). From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	There are descriptions that among 118 workers repeatedly exposed by inhalation to this substance at plants producing alkyd or polyester resins, rhinitis and inflammation of the upper respiratory tract in 28 workers, chronic bronchitis in 13 workers, and asthma in 21 workers were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 75 (2009), ACGIH (7th, 2014)), and that among 35 workers repeatedly exposed by inhalation to this substance at an alkyd resin manufacturing plant, conjunctivitis in 16 workers, rhinitis in 14 workers, asthma in 5 workers, and chronic bronchitis in 6 workers were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), CICAD 75 (2009)). In experimental animals, in studies in which rats or mice were administered by feeding for 7 weeks or 2 years, no clear target organ toxicity was observed even at doses exceeding 1,000 mg/kg/day (SIDS (2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2014)). On the other hand, as for the inhalation route, although reliability was limited, in a study in which guinea pigs were exposed by inhalation repeatedly (8.5 mg/m3: 3 hours/day, exposure for 8 months in a cycle of 4-consecutive-day exposures followed by 10 days without exposure), effects on the eyes (conjunctivitis) and respiratory organs (hyperemia of the respiratory tract mucosa and inflammation of the lungs) were observed (ACGIH (7th, 2014), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, it was classified in Category 1 (respiratory organs).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 96-hour LC50 > 99 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	It was classified as "Not classified" due to being rapidly degradable (readily biodegradable (a 2-week degradation rate by BOD: 85.2%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), 60-day NOEC = 10 mg/L for fish (Oncorhynchus mykiss) (SIDS, 2005), 21-day NOEC = 16 mg/L for crustacea (Daphnia magna), and 72-hour NOEC = 32 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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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