Registration Dossier
Registration Dossier
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EC number: 202-940-9 | CAS number: 101-41-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The NOAEL for daily oral gavage of the structural analogue Ethyl phenylacetate in male and female rats was found to be 200 mg/kg bw/d, as well as the NOAEL for reproduction/development.
Effect on fertility: via oral route
- 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
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a combined repeated dose oral gavage toxicity study with the reproduction/developmental toxicity screening the test item Ethyl phenylacetate was administered by oral gavage to Sprague-Dawley rats (at least12 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 the 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. One dead fetus was observed in the uterus o one female. It was considered to have toxicological relevance since test item-related systemic (decreased body weight gain) and reproduction/developmental (increased perinatal death and decreased live litter size) adverse effects were observed at 800 mg/kg bwduring the study.
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 was observed in males and females at 800 mg/kg bw. Changes were noted in hematology, clinical chemistry and organ weights, but these were not considered adverse since they were not correlated with microscopic findings and reversed after recovery period.
In reproductive/developmental observations, at 800 mg/kg bw, a significant increase in gestation period and perinatal death and decrease in live litter size and viability index were observed. A significant decrease in body weight of male and female pups was observed on PND 0 (down to 83% of control) and 13 (90% of control).
In conclusion, systemic adverse effects including decreased body weight gain were observed at 800 mg/kg bw. Regarding reproduction/developmental effects, decreases in regularity of estrus cycle, live litter size, viability index and body weights in F1 pups were observed at 800 mg/kg. Increases in gestation period and perinatal death were also observed at 800 mg/kg bw. Therefore, the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity and reproduction/developmental toxicity was considered to be 200 mg/kg bw /day, respectively.
Effects on developmental toxicity
Description of key information
Systemic adverse effects including decreased body weight gain were observed at 800 mg/kg bw. Regarding reproduction/developmental effects, decreases in regularity of estrus cycle, live litter size, viability index and body weights in F1 pups were observed at 800 mg/kg. Increases in gestation period and perinatal death were also observed at 800 mg/kg bw. Therefore, the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity and reproduction/developmental toxicity was considered to be 200 mg/kg bw /day, respectively.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
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. Available
data on toxicity to reproduction and developmental toxicity indicate
impairment of reproduction only together with general toxicity, thus not
fullfilling requirements for classification under Regulation (EC) No
1272/2008 (CLP). Therefore,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.
Additional information
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