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Acute Toxicity: oral

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acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near guideline, GLP animal experimental study, available as published report, fully adequate for assessment

Data source

Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Phenylethyl alcohol
Phenylethyl alcohol

Test animals

Details on test animals or test system and environmental conditions:
TEST ANIMALS-Source: Blue Spruce Farm, Altamont, New York- Sex: Male and female- Weight at study initiation: 180-280 g- after fasting- Acclimation period: Five days - Housing: Rats housed individually in stainless steel -wire mesh cages. - Diet Wayne Lab Blox, ad libitum, checked daily and added or replaced as needed- Water availability- fresh tap water, fit for human consumption ad libitum: ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3 °C Humidity (%): 30-70- Photoperiod (hrs dark / hrs light): 12/12.

Administration / exposure

Route of administration:
oral: gavage
other: other: 0.25% methylcellulose
Details on oral exposure:
Volume administration: 5 ml/kg
Frequency and duration of administration: Once
Rational for route of administration: Potential route for human exposure
0, 1000, 1600, 2000, 2500 and 3200 mg/kg
Rational for dose selection: Based upon the results of the dose-range finding study
No. of animals per sex per dose:
Control animals:
Details on study design:
Five groups of 10 rats, 5 female and 5 male, were fasted for 18 hr. The test material was administrated once orally, by gavage at 1000, 1600, 2000, 2500 and 3200 mg/kg. Dose levels were based on a preliminary dose-range finding study.
Duration of observation period following administration: 14 days- Frequency of observations: animals were observed at one, four, twenty-four hours after dosing and twice daily for fourteen days. - Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight.
The LD50 and 95% CI limits were calculated according to the method of Litchfield and Wilcoxon.

Results and discussion

Effect levelsopen allclose all
Dose descriptor:
Effect level:
1 603.3 mg/kg bw
Based on:
test mat.
95% CL:
1 399.6 - 1 850.4
Dose descriptor:
Effect level:
1 692.6 mg/kg bw
Based on:
test mat.
95% CL:
1 433.3 - 1 998.9
Remarks on result:
other: The data generated did not lend itself to the method of Litchfield and Wilcoxon
None of the animals died at 1000 mg/kg dose level. Five of 10 died at 1600 mg/kg dose level. Nine of 10 died at 2000 mg/kg dose level.
Clinical signs:
other: Signs observed included diarrhea, decreased activity, poor grooming, piloerection, exophtalmus, ataxia, chromodacryorrhea, hypersensitivity, hyperactivity, decreased body tone, tremors, dyspena, wheezing, prostration, abnormal stance, ptosis, abnormal gai
Gross pathology:
Necrospy: Necropsy of animasl revelead distended stomachs with hemorrhages of the glandular mucosa, red foci on the thymus, discolored adrenals and fluid- filled fladders. Terminal necrospy revelead no visible lesions in the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Migrated information Criteria used for interpretation of results: EU
The acute oral LD50 was determined to be 1609.3 mg/kg (male and female, combined).
Executive summary:

The acute oral toxicity of Phenyl ethyl alcohol was studied in a GLP-compliant, not following a specific guideline. The animals were exposed once to 0, 1000, 2000, 2500 and 3600 mg/kg bw/day by oral gavage and observed for 14 days. There were no toxicologically significant effects at doses <1000 mg/kg. The rats were observed immediately and at 1, 4, 24 hours after dosing and twice daily for 14 days in order to evaluate clinical signs and mortality.The calculated LD50 for male and female animals was determinated to be 1609.3 mg/kg with 95% confidence limits of 1399.6 to 1850.4 mg/kg according to the method Litchfield and Milcoxon. Necroscopy of the animals dying on the study revealed distended stomachs with hemorrhages present on the mucosa. Distended bladders, red foci on the thymus and discoloured adrenals were also observed. Terminal nescropy revealed no visible lesions in any the surviving animals.