GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 85-44-9
Chemical Name Phthalic anhydride
Substance ID 24B6521
Classification year (FY) FY2012
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) Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th 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
-
-
- - There is the information it is combustible (ICSC (J) (2003)), but there are no data in the prescribed test method.
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 (J) (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 the information that stainless steel and aluminum are durable, and carbon steel is durable only when moisture is shut off (Hommel (1996)).

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
There are reports on the latest LD50 values for rats of 1,530 mg/kg (SIDS (2005)), 4,020 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2011)), 800-1,600 mg/kg (NTP TR159 (1979)), two correspond to Category 4, and one corresponds to "Not classified" in the Classification JIS (Category 5 in UN GHS classification). Category 4 was adopted, to which most corresponded.
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classifieed as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification or "Not classified") based on LD50 values of > 10,000 mg/kg and > 3,160 mg/kg for rabbits (SIDS (2005)).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - An LC50 value of > 0.21 mg/L by 1-hour exposure of rats (converted 4-hour equivalent value: > 0.0525 mg/L) is reported (SIDS (2006)), but because the category cannot be determined, the classification is not possible. Besides, because the test concentration (0.21 mg/L) is above the saturated vapour pressure concentration (0.004 mg/L), it was regarded as a test with the dust.
2 Skin corrosion/irritation Not classified
-
-
- - It is reported that in a test by 4-hour semi-occlusive application of 550 mg of the test substance to the rabbit skin (OECD TG404), the average skin irritation index was 1.21, and it was slightly irritating (SIDS (2005)), and in another test by 24-hour semi-occlusive application of 500 mg (moistened with water) to the rabbit skin, the primary dermal irritation index (PDII) was 1.5, and it was slightly irritating (SIDS (2005)). Therefore, it was classified as "Not classified" in the Classification JIS (corresponding to Category 3 in UN GHS classification). Besides, there is a report on skin irritation after occupational exposure of humans, but it is described that impurities present in the technical grade seem to contribute to the symptoms (SIDS (2005)).
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
In a test in which 50 mg of the undiluted test substance was applied to the conjunctival sac of rabbits, irritation was seen in the cornea, iris, and conjunctiva, but all except conjunctival redness was reversible during the 7-day observation period, and it was assessed as moderately irritating (SIDS (2005)), in another test, after application of 100 mg of the undiluted test substance to the conjunctival sac of rabbits, mean scores at 24-72 hours (equivalent to AOI) were 71-81, it was judged as irritating (SIDS (2005)), and in a test by application of 100 mg of the undiluted test substance to the rabbit eye, the mean score (equivalent to AOI) was 59.2 after 24 hours, and it was assessed to be irritating (SIDS (2005)). Based on assessment results in the above tests, including irritation scores, it was classified in Category 2A. Besides, it was classified in Xi:R41 in EU classification (EC-JRC (ESIS) (Access on Apr. 2012)), corresponding to Category 1.
4 Respiratory sensitization Category 1A


Danger
H334 P304+P340
P342+P311
P261
P284
P501
In a plant handling phthalic anhydride (PA), there is a report on 28 workers (24%) with rhinitis, 13 (11%) with chronic bronchitis, and 21 (18%) with asthma among 118 workers exposed to the dust during work, and asthma occurred 0.1-16 years after exposure (OEL Documentations Vol. 40 (Japan Society For Occupational Health (JSOH), 1998)). On the other hand, in a survey of workers who produced polyester resins, 46% of the workers in the high exposure group (1500-1740 microg/m3) had conjunctivitis, 40% had rhinitis, and 14% had asthma (CICAD 75 (2009)). This substance has been known as a respiratory sensitizer since 1939 when the first case of asthma and allergic rhinitis was reported (SIDS (2006)). Because the Japan Society for Occupational Health (JSOH) classified this substance as occupational sensitizers to the airway Group 1 (Recommendation of Occupational Exposure Limits Vol. 53 (Japan Society For Occupational Health (JSOH), 2011)), it was classified in Category 1A.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
A maximization test (positive rate 90%) and a Buehler test with guinea pigs, and a local lymph node test with mice gave positive results, and it was judged as sensitizing in all (SIDS (2006)). As for humans, it is reported that 191 workers at a factory processing epoxy resins, including this substance, were patch tested, and an allergic response to this substance was observed in 14% of the workers (SIDS (2006)), and seven (7%) out of 99 patients with hypersensitivity to epoxy resins who were treated in a dermatology clinic reacted to this substance in a patch test (DFGMAK-Doc.25 (2009)). Furthermore, this substance is classified as a contact allergen in Contact Dermatitis (Frosch) (Contact Dermatitis (Frosch) (5th, 2011)). Therefore, it was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, it is reported that an Ames test was negative (SIDS (2005), NTP DB (Access on Apr. 2012)), and chromosomal aberration tests with CHO cells were mostly negative (Initial Risk Assessment Report Ver.1.0 No.120 (NITE, CERI, NEDO, 2008), NTP DB (Access on Apr. 2012)), although there are some positive results (SIDS (2005)), and a gene mutation test with mouse lymphoma cells was positive (NTP DB (Access on Apr. 2012)).
6 Carcinogenicity Classification not possible
-
-
- - It was classified as "Classification not possible" because ACGIH classified it in A4 for carcinogenicity (ACGIH (2001)). Besides, in 2-year diet administration tests with rats and mice, there were no effects on survivals in either animal species, no tumors occurred in the incidences that could be related to the treatment, and it was concluded that this substance was not carcinogenic under the conditions of the tests (NTP TR159 (1979)).
7 Reproductive toxicity Classification not possible
-
-
- - It is reported that in a developmental toxicity test by diet administration to pregnant rats during the organogenesis period (gestational days 7-16), there were no changes in postimplantation loss, and numbers and sex ratio of live fetuses at the doses where reduced weight gain was observed as general toxicity in maternal animals, and morphological examination of fetuses revealed no evidence of developmental toxicity (SIDS (2005)). However, because effects on sexual function and fertility are unknown due to no data, it was classified as "Classification not possible." Besides, it is described that effects on spermatogenesis, the testis, and epididymis were seen after inhalation exposure of male rats for 45 days before mating (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), but the details are unknown.
8 Specific target organ toxicity - Single exposure Category 2 (systemic toxicity), Category 3 (respiratory tract irritation)



Warning
H371
H335
P308+P311
P260
P264
P270
P405
P501
P304+P340
P403+P233
P261
P271
P312
From the report that oral administration of 500 mg/kg or above to rats caused death, and signs observed were sedation, imbalance, and bloody eyes (SIDS (2005)), and because the target organ could not be specified at doses corresponding to the guidance values for Category 2, it was classified in Category 2 (systemic toxicity). On the other hand, as acute effects in humans, it is described that this substance in the vapour, fumes, or dust is an irritant to the mucous membrane and upper respiratory tract, and initial exposure produced coughing, sneezing, and burning sensations in the nose and throat (SIDS (2005)), and as a case report, it is reported that a female tanker truck driver spilled this substance during transporting it and were exposed to a gaseous substance at a high concentration by inhalation, and had a burning sensation in the upper respiratory tract and coughing immediately after exposure (Initial Risk Assessment Report Ver.1.0 No.120 (NITE, CERI, NEDO, 2008)). Therefore, it was classified in Category 3 (respiratory tract irritation). Besides, it was classified in Xn; R22 and Xi: R37 in EU classification (EC-JRC (ESIS (Access on Apr. 2012))).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs)


Danger
H372 P260
P264
P270
P314
P501
It is described that in humans, this substance in the vapour, fumes, or dust is an irritant to the mucous membrane and upper respiratory tract, and repeated or continued exposure may result in inflammation of the respiratory tract, nasal ulceration and bleeding, atrophy of the mucous membranes, loss of smell, hoarseness, bronchitis, and so on (SIDS (2005)), and as a case report, it is reported that in a survey of workers who handled this substance at a factory manufacturing alkyd resins, etc., incidences of respiratory disorders such as rhinitis, inflammation of the upper respiratory tract, and chronic bronchitis increased with the increasing air concentrations of this substance during handling (Initial Risk Assessment Report Ver.1.0 No.120 (NITE, CERI, NEDO, 2008)). Therefore, it was classified in Category 1 (respiratory system). Besides, in 7-week or 2-year diet administration tests with rats and mice, there were no effects on survivals or no other treatment-related adverse effects except for reduced weight gain observed in the high dose group or low and high dose groups (NTP TR159 (1979)), which means "Not classified" in the oral route. And it is described that effects on spermatogenesis, the testis, and epididymis were seen after inhalation exposure of male rats to a 1 mg/m3 concentration for 45 days before mating (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003)), but exposure time and test details are unknown.
10 Aspiration hazard Classification not possible
-
-
- - No data available.

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) 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)).
11 Hazardous to the aquatic environment (Long-term) 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)).
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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