Phenethyl phenylacetate

Endpoint summary

Description of key information

Acute oral toxicity: The acute oral toxicity was determined in a weight of evidence approach. The LD50 was determined to be >2000 mg/kg bw. 

Acute dermal toxicity: A study was performed to assess the acute dermal toxicity of the test material in the Sprague-DawleyCD strain rat. The acute dermal median lethal dose (LD50) of the test material in the Sprague-DawleyCD strain rat was found to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

3 190 mg/kg bw

Quality of whole database:

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

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:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline study

Additional information

Acute oral toxicity

A weight of evidence approach with 4 studies with different species was done to cover this endpoint.

Jenner (1964)

The potential of the test substance was tested in a study equivalent to OECD guideline 401. The test material was administered to 5 male and 5 female Osborne-Mendel rats per dose. Animals were subjected to an 18 hour predose fasting. All doses were given by intubation. The animals were observed over a 2 week period for mortality and/or systemic effects. LD50 results were calculated per Litchfield-Wilcoxon (1949). No further details were provided. The LD50 was determined to be 15390 mg/kg bw. Mortality occured between 4 h and 5 days. Depression soon after treatment and scrawny appearance for several days were observed during the study.

Zaitsev (1974) - rats

Groups of 6 white rats (of the same sex) were administered the test material in the form of a 20 - 45% solution in sunflower oil (2.0 - 5.0 mg/kg body weight). The animals were observed for 15 days, and the LD50 was calculated per Kerber's method. No further details were provided. The LD50 value was determined to be 3190 mg/kg bw.

Zaitsev (1974) - mice

Groups of 6 white mice (of the same sex) were administered the test material in the form of a 20 - 45% solution in sunflower oil (2.0 - 5.0 mg/kg body weight). The animals were observed for 15 days, and the LD50 was calculated per Kerber's method. No further details were provided. The LD50 value was determined to be 3190 mg/kg bw.

Zaitsev (1974) - guinea pigs

Groups of 6 guinea pigs (of the same sex) were administered the test material in the form of a 20 - 45% solution in sunflower oil (2.0 - 5.0 mg/kg body weight). The animals were observed for 15 days, and the LD50 was calculated per Kerber's method. No further details were provided. The LD50 value was determined to be 3190 mg/kg bw.

Conclusion: The potential of the acute oral toxicity of the test item was tested on rats, mice and guinea pigs. In a study equivalent to OECD guideline 401 the LD50 was determined to be 15390 mg/kg bw. This result is in line with 3 further studies performed on rats, mice and guinea pigs. The determined LD50 value was 3190 mg/kg bw. In conclusion it can be stated that the test substance is not acute oral toxic.

Acute dermal toxicity

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat according to OECD guideline 402. A group of ten animals (five males and five females) was given a single, 24 -hour, semioccluded dermal application of undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Mortality: There were no deaths. Clinical Observatians: There were no signs of systemic toxicity. Skin Irritation: There were no signs of dermal irritation. Bodyweight: All animals showed expected gains in bodyweight over the study period. Necropsy: No abnormalities were noted at necropsy. Conclusion. The acute dermal median lethal dose (LD50) of the test material in the Sprague- Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.

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 dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.