Methyl phenylacetate

Endpoint summary

Description of key information

Acute oral toxicity: Two acute oral toxicities studies (one read-across study) are available. Both studies are showing a LD50 value of >2000 mg/kg/bw. 

Acute dermal toxicity: Two acute dermal toxicities studies (one read-across study) are available. Both studies are showing a LD50 value of > 2000 mg/kg/bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 550 mg/kg bw

Quality of whole database:

Basic data given, no GLP study, acceptable, well documented publication, similar to guideline

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 400 mg/kg bw

Quality of whole database:

Basic data given, acceptable, well documented publication, no GLP study, similar to guideline

Additional information

A weight of evidence approach was done with one acute oral toxicity study with the test item and one read across study. The read across approach was applied using data of Ethyl Phenylacetate (CAS 101 -97 -3) as this substance was considered to show similar toxicological properties as compared to the test item. For further justification please refer to IUCLID section 13.

Acute oral toxicity

The acute oral toxicity of the test item was determined in a study equivalent to OECD guideline 401. The study was conducted with 10 rats per group. The test item was administered in doses of 670, 1310, 2560 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2560 mg/kg bw onwards. The LD50 was determined to be 2550 mg/kg bw. Slight lethargy was observed in animals of all doses.

In a read-across study of Moreno, 1973, the acute oral toxicity of Ethyl Phenylacetate (CAS 101 -97 -3) was determined in a study equivalent to OECD guideline 401. The study was conducted with 10 rats per group. The test item was administered in doses of 1480, 2220, 3330 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2200 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw. Lethargy was observed in animals of the highest dose group.

Conclusion: Both studies are performed equivalent to OECD guideline 401. The results of both studies lay in the same range. Mortality was observed in doses from 2560 mg/kg bw onwards in the study performed with the test item. The LD50 value was determined to be 2550 mg/kg bw. Similar results were observed in the read across study. The mortality was observed in doses from 2200 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw. In conclusion it can be stated that the test substance has not to be classified for acute oral toxicity.

Acute dermal toxicity

A weight of evidence approach was done with one acute dermal toxicity study with the test item and one read across study. The read across approach was applied using data of Ethyl Phenylacetate (CAS 101 -97 -3) as this substance was considered to show similar toxicological properties as compared to the test item. For further justification please refer to IUCLID section 13.

The acute dermal toxicity of the test item was determined in a study similar to OECD guideline 402. The study was conducted with 4 rabbits. They received a dermal application of 1250, 2500 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed from the lowest concentration level onwards. The calculated LD50 was determined to be 2400 mg/kg bw. Signs of lethargy were observed.

In a read-across study of Moreno, 1973, the acute dermal toxicity of Ethyl Phenylacetate (CAS 101 -97 -3) was determined in a study similar to OECD guideline 402. The study was conducted with 10 rabbits per group. The test item was administered in doses of 1480, 2220, 3330 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in one of 10 animals. The LD50 was determined to be >5000 mg/kg bw. In 5/10 animals anorexia was observed on days 1, 2. In 1/10 animals extreme weakness prior to death was observed.

Conclusion: Both studies are performed equivalent to OECD guideline 402. The results of both studies lay in the same range. Mortality was observed in doses from the lowest concentration level onwards in the study performed with the test item. The LD50 value was determined to be 2400 mg/kg bw. Similar results were observed in the read across study. Mortality was observed in one of 10 animals. The LD50 was determined to be > 5000 mg/kg bw. In conclusion it can be stated that the test substance has not to be classified for acute dermal toxicity.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for acute oral and acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.