NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	85-44-9
Chemical Name	Phthalic anhydride
Substance ID	H26-B-131, -
Classification year (FY)	FY2014
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	FY2012 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)
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	- -	-	-	It is described in ICSC (2003) that it is combustible, but the classification is not possible due to no data.
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 570 deg C (ICSC (2003)).
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
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)).

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 P362+P364 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.
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."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
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.
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)).
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.
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.
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.
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)).
6	Carcinogenicity	Classification not possible	- -	-	-	Since it was classified in A4 by ACGIH (ACGIH (7th, 2014)), it was classified as "Classification not possible."
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)).
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).
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).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
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.

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