GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 131-17-9
Chemical Name Diallyl phthalate
Substance ID 25B0006
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 FY2008  
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
-
-
- - A flash point is 166 deg C (Closed cup) (HSDB (Access on June 2013)).
7 Flammable solid Not applicable
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is an allyl group, which is an unsaturated bond in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 358 deg C (ICSC (2006)).
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
It was classified in Category 4 from LD50 data of 656 mg/kg (females), 891 mg/kg (males), 896 mg/kg (SIDS (2005)), and 970 mg/kg (DFGOT vol. 9 (1998)) in tests with rats.
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification) from LD50 of 3,300 mg/kg (SIDS (2005)) and 3,800-3,900 mg/kg (DFGOT vol. 9 (1998)) for rabbits.
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) Category 4


Warning
H332 P304+P340
P261
P271
P312
It was classified in Category 4 based on LC50 values for rats of 4.47 mg/L (SIDS (2005)) and 8.3 mg/L (1 hour, converted value: 2.1 mg/L/4 hours) (SIDS (2005)) (because these were higher than the saturated vapour pressure concentration of 0.002 mg/L (ICSC (2006)), a reference value in the unit of mg/L was applied as dust/mist). In the previous classification, Category 4 was thought to be mistaken for Category 3 from the rationale. The inhalation test by 4-hour exposure to dust/mist was added in this classification.
2 Skin corrosion/irritation Not classified
-
-
- - The results of three tests are reported in SIDS (2005). In a skin irritation test with rabbits of reliability 1 (according to GLP and 16 CFR 1500.41), after a 24-hour occlusive application of 0.5 mL of this substance to the back, the primary skin irritation index was 0.5, and it was slightly irritating. And in a skin irritation test with rabbits of reliability 2 (according to DOT 49 CFR 173.1200), after a 4-hour occlusive application of 0.5 mL of this substance, the primary skin irritation index was 0, and it was not irritating. Furthermore, it is also described in PATTY (6th, 2012) that there was no irritation after a 4-hour occlusive application of this substance, although the test details are unknown. It was classified as "Not classified" based on the above information.
3 Serious eye damage/eye irritation Not classified
-
-
- - In SIDS (2005), there is a report on the results of three tests, and the reliability was 2 for one and 4 for two. In an eye irritation/corrosion test with rabbits (according to GLP and FSHA 16 CFR 1500), no irritation was observed in any of all six animals (SIDS (2005)). Based on this test result, it is concluded in SIDS (2005) that this substance is considered non-irritant to the eyes. It is also described in PATTY (6th, 2012) that the substance is not irritating to rabbit eyes, although the test details are unknown because it is an unpublished report. It was classified as "Not classified" based on the above information.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
In a local lymph node test with mice (LLNA method: according to GLP and OECD guideline 429), SI values were 3.23 for a 5% solution of this substance and 10.74 for a 50% solution (SIDS (2005)). Based on the data of reliability 1, it is concluded in SIDS (2005) that this substance is considered to be a skin sensitizer. It was classified in Category 1 based on the above information.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. As for a positive result in a chromosomal aberration test with mouse bone marrow, because reproducibility within the test and dose-response relationship are unclear, and a micronucleus test with mouse bone marrow was negative, the substance was judged to be not clastogenic in vivo (SIDS (2005), Patty (6th, 2012)). Besides, in in-vitro tests, it was reported to be weakly positive in a bacterial reverse mutation test and positive in a chromosomal aberration test, a micronucleus test, and a mouse lymphoma test (SIDS (2005), Patty (6th, 2012), DFGOT vol. 9 (1998)). A weakly positive result in a reverse mutation test indicates the reactivity of this substance to DNA, and it is thought that further knowledge is needed to classify germ cell mutagenicity of this substance.
6 Carcinogenicity Classification not possible
-
-
- - In an oral dose carcinogenicity test with mice, an increased incidence of lymphoma was observed in males, but it was not considered to be clear effects caused by the administration of test substance. Probably the maximum tolerance dose had not been achieved in the mouse test, but it is concluded that no carcinogenicity was observed (NTP TR242 (1983)). In an oral dose carcinogenicity test with rats, an increased incidence of mononuclear cell leukemia was found in females of the 100 mg/kg dose group. However, it is described that because of the variability in the incidence of this tumor in aged animals and the difficulty in definitively diagnosing it, there was equivocal evidence of carcinogenicity in female rats. And there was no evidence of carcinogenicity in male rats (NTP TR284 (1985)). As described in the above, because of insufficient information on carcinogenicity, it was classified as "Classification not possible."
7 Reproductive toxicity Classification not possible
-
-
- - In a reproductive/developmental toxicity screening test with rats, dystocia was observed in 3/10 females in the high dose group (SIDS (2005)), but it was dystocia which was all observed before death, and it was thought to be secondary effects caused by marked maternal toxicity, not toxicity on fertility. On the other hand, in a developmental toxicity test with rats, only developmental toxicity (lower values of body weights, delayed ossification) was seen in fetuses at the doses where maternal animals showed severe general toxicity such as death (2/10 animals) and reduced weight gain (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009)). From the above, although toxicity on fertility was not found in females, there is no fertility information in males, and lower values of body weights and delayed ossification in fetuses are insufficient to assign reproductive toxicity. Therefore, it was classified as "Classification not possible" according to the GHS classification guidance for the Japanese government.
8 Specific target organ toxicity - Single exposure Category 2 (liver)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
In an inhalation test with rats, lesions were observed in the respiratory organs, but they were necropsy findings in dead animals (SIDS (2005)). In oral administration, elevated activities of serum enzymes (AST, ALT, alkaline phosphatase (dogs), ALT (rats)) indicating liver disorder were found at 800 mg/kg for dogs (SIDS (2005), DFGOT vol. 9 (1998)) and at 400 mg/kg for rats (DFGOT vol. 9 (1998)), and it is reported in NTP TR 284 (1985) that histopathological changes in the liver (periportal hepatocellular necrosis, doses unknown) were observed in rats. From the above, this substance was judged to cause liver disorder in experimental animals by single exposure at the doses within the guidance value range for Category 2, therefore it was classified in Category 2 (liver).

9 Specific target organ toxicity - Repeated exposure Category 2 (liver)


Warning
H373 P260
P314
P501
Histopathological changes occurred in the liver in males at or below 50 mg/kg in an NTP's 13-week oral administration test with rats, but no changes were found in mice even after dosing at 400 mg/kg (SIDS (2005)). However, also in a reproductive/developmental toxicity screening test with rats, histopathological changes in the liver were observed in both males and females in the high dose group (SIDS (2005)), and it is thought that there is a difference between species. It was classified in Category 2 (liver) based on the above information.
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 1


Warning
H400 P273
P391
P501
From 96-hour LC50 = 0.23 mg/L for fish (Oncorhynchus mykiss) (SIDS, 2005), it was classified in Category 1.
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: 92, 79, 76% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and 72-hour NOEC = 2.38 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, there are data: 96-hour LC50 = 0.23 mg/L for fish (Oncorhynchus mykiss) (SIDS, 2005). However, it is rapidly degradable (a degradation rate by BOD: 92, 79, 76% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and low bioaccumulation is estimated (log Kow = 3.23 (ICSC, 2004)). 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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