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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In a combined repeated dose oral gavage toxicity study with the reproduction/developmental toxicity screening with the structural analogue Ethyl phenylacetate the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity was considered to be 200 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
GLP and Guideline study

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test item, Ethyl phenylacetate, was administered by oral gavage to Sprague-Dawley rats (12 animals per sex per group) at dose levels of 0, 50, 200 and 800 mg/kg with a dose volume of 2 mL/kg in corn oil as vehicle. Males and females were dosed for two weeks prior to mating and continued through the day before sacrifice in males (at least 50 days), and continued through the lactation day (LD) 13 in females. Additional animals in recovery group at 0 and 800 mg/kg (6 animals per sex per group) were also administered but not mated, and then assigned to 2 weeks of recovery period after the completion of administration. No deaths or moribund animals occurred in any group throughout the study. Three females were subjected to unscheduled sacrifice on GD 27 because of non-parturition. There were no test item-related changes in the macroscopic and microscopic of unscheduled sacrificed animals. No test item-related change was observed in food consumption, functional behavior examination, motor activity examination, macroscopic and microscopic findings. A significant decrease in body weight gain (76% and 69% of control, respectively) was observed in males and females at 800 mg/kg during the treatment days 1 to 50. Changes in hematology, clinical chemistry and organ weights were not considered adverse since they were not correlated with microscopic findings and reversed after recovery period.

Therefore, the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity was considered to be 200 mg/kg/day.

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 (EC) No 1272/2008. Based on available data on repeated dose toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.