Registration Dossier
Registration Dossier
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EC number: 203-113-5 | CAS number: 103-45-7
Endpoint summary
Administrative data
Description of key information
Oral repeated dose toxicity studies are available using rats and mice as the test species. The studies were conducted for a period of 14 days or 13 weeks. There is no indication that the studies conformed to guidelines or were GLP compliant. The NOAEL derived for subchronic exposure to rats was 250 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
- 250 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- A number of high-quality studies performed by the US NTP on the read-across substance benzyl acetate are avaialble.
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
A number of high quality repeated dose toxicity studies are available for the read-across substance benzyl acetate (US NTP).
A 14-day range-finding gavage study per in the rat reports a NOAEL of 500 mg/kg bw/d; a 14-day study per in the mouse reports a NOAEL of 1000 mg/kg bw/d. A 13-week gavage study performed in the rat reports a NOAEL of 500 mg/kg bw/d for males and 250 mg/kg bw/d for females; the 13-week gavage study in the mouse reports a NOAEL of 1000 mg/kg bw/d. A 13-week dietary study performed in the rat reports higher NOAEL values of 900 and 480 mg/kg bw/d in males and females respectively; a 13-week dietary study in the mouse reports a LOAEL of 425-650 mg/kg bw/d.
A 4-month drinking water study is available for phenylethyl acetate but is not considered to be sufficiently reliable due to methodological limitations.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
A series of studies were available to provide endpoints based on read across to benzyl acetate. The subchronic gavage study in rats provides the lowest NOAEL from which to derive a starting dose descriptor for derivation of appropriate DNELs. Data from mice or from differing study durations or from investigations of gavage or dietary administration routes provided useful support for the key study.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach
Justification for classification or non-classification
Findings in the repeated dose toxicity studies do not indicate any concerns at relevant dose level: no classification for repeated dose toxicity is therefore proposed.
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