GHS Classification Result

Chemical Name：Bis(2-ethylhexyl) phthalate
CAS：117-81-7

Result：
ID: 183
Classifier: Inter-ministerial Committee on GHS
Year Classified: FY2006
Reference Manual: GHS Classification Manual （10 Feb, 2006）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - Containing no chemical groups with explosive properties
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Classified as "liquid" according to GHS definition
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Classified as "liquid" according to GHS definition
5 Gases under pressure Not applicable - - - - Classified as "liquid" according to GHS definition
6 Flammable liquids Not classified - - - - The flash point is 215degC (open cup flash test) (ICSC, 2002)
7 Flammable solids Not applicable - - - - Classified as "liquid" according to GHS definition
8 Self-reactive substances and mixtures Not applicable - - - - Containing no chemical groups with explosive or self-reactive properties
9 Pyrophoric liquids Not classified - - - - Not pyrophoric when in contact with air at ordinary temperatures; the auto-ignition temperature is 350degC (ICSC, 2002)
10 Pyrophoric solids Not applicable - - - - Classified as "liquid" according to 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 - - - - Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)
13 Oxidizing liquids Not applicable - - - - Organic compounds containing oxygen (but not fluorine and chlorine), with the oxygen bound to carbon and hydrogen (but not to other elements)
14 Oxidizing solids Not applicable - - - - Classified as "liquid" according to GHS definition
15 Organic peroxides Not applicable - - - - Organic compounds containing no "-O-O-" structure
16 Corrosive to metals Classification not possible - - - - No data available

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Based on the testing data of rat LD50 (oral route) of over 20,000, over 40,000mg/kg (EU-RAR No.42 (2003)); 30,600mg/kg (ATSDR (2002)), 33,800 mg/kg (ACGIH (7th, 2001)).
1 Acute toxicity （Dermal） Not classified - - - - Classified using the data on rabbits, because no data on rats were available. Based on the LD50 value of 24,700mg/kg calculated from the testing data of rat LD50 (dermal route) of 24,500mg/kg (EU-RAR No.42 (2003)), 25,000mg/kg (EHC131 (1992)), and 24,750mg/kg, (ACGIH (7th, 2001).
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Due to the fact that the substance is "liquid" according to the GHS definition and inhalation of its gas is not expected.
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available
1 Acute toxicity （Inhalation: Dusts and mists） Not classified - - - - Based on the rat LC50 (mist) of over 10.62 mg/L (EU-RAR No.42 (2003)).
2 Skin corrosion/irritation Category 3 - Warning H316: Causes mild skin irritation P332+P313: If skin irritation occurs: Get medical advice/attention. Based on the description in ATSDR (2002) and EU-RAR No.42 (2003): Phthalic acid, bis (2-ethylhecyl) causes mild irritation, if any, to the skin; Four-hour application causes mild skin irritation.
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		Based on the description in ACGIH (7th, 2001), ATSDR (2002), EHC 131 (1992) and EU-RAR No.42 (2003): Phthalic acid, bis (2-ethylhecyl) is considered "non-irritating" or "mildly irritating" to the eyes, with the latter adopted for classification.
4 Respiratory sensitization Classification not possible - - - - No data available
4 Skin sensitization Not classified - - - - Based on the description in EU-RAR No.42 (2003) - Phthalic acid, bis (2-ethylhecyl) does not cause skin sensitization, according to the results of guinea pig skin sensitization tests (performed based on the Maximization and Buehler Methods).
5 Germ cell mutagenicity Not classified - - - - Due to the fact that admistration route was not proper in the tests where positive results were observed, and based on the negative data on other dominant lethal tests and micronucleus tests, though positive results were observed in multi-generation mutagenicity tests (dominant lethal tests), described in CERI-NITE Hazard Assessment No.7 (2004), ATSDR (2002).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Due to the fact that the substance is classified as Category R by NTP (2005), Group B2 by EPA (2002), Category A3 by ACGIH (2001) and Category 2B by the Japan Society for Occupational Health, although classified as Group 3 by IARC.
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on the evidence of effects on offspring at dosing levels not toxic to parent animals, described in U.S. NTP-CERHR, CERI-NITE Hazard Assessment No.7 (2004).
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Insufficient data available
9 Specific target organ toxicity - Repeated exposure Category 2 (testis, liver) Warning H373: May cause damage to organs through prolonged or repeated exposure (testis, liver) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		Based on the evidence from animal studies including "vacuolation of Sertoli cells in the testes" (CERI-NITE Hazard Assessment No.7 (2004)), "hepatocyte enlargement, periportal fat deposition, lipid replete lysosome, glycogen depletion, changes in the bile duct structure, induction of peroxisomal enzyme and cytochrome P450 activities" (CERI Hazard Data 96-17 (1997)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 2.
10 Aspiration hazard Classification not possible - - - - No data available

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Not classified - - - - Since acute toxicity is not reported within the aqueous solubility concentrations (0.003mg/L (EU-RAR (2001))), it was classified into Not classified.
11 Hazardous to the aquatic environment （Long-term） Category 4 - - H413: May cause long lasting harmful effects to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Although it is water-insolubility and acute toxicity was not reported within the aqueous solubility concentrations,since the decomposition rate was not high (the half life is 50 days by bio-decomposition in the water (EU-RAR (2001))and there was the bio-accumulation (BCF=840 (EU-RAR (2001)), it was classified into Category 4.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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