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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)

Data source

Reference Type:
study report

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal 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

New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Age at study initiation:
- Weight at study initiation: 2-3 kilograms
- Fasting period before study:
- Housing: individual cages sized in accordance with the Guide for the Care and Use of Laboratory Animals of the Institute of Laboratory Resources, national research Council
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Food analysis: there were no contaminants
- Water (e.g. ad libitum): Fresh tap water, fit for human consumption was available ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Indistries Inc. Waterford, Wisconsin.
- Acclimation period: 5 days

- Temperature (°C): 20°C+/- 3°C
- Humidity (%): 30-70%:
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs night


Administration / exposure

Type of coverage:
other: administred as received
Duration of exposure:
24 hrs
2000 mg/kg (Limit Test)
1600, 2500, 4000 mg/kg
No. of animals per sex per dose:
Total: 10
Male: 5
Female: 5
Details on study design:
The trunk of the animals was shaved in order to have at least 10% (about 240 cm) of the dorsal body surface area available for application of the test material. Immidiately prior dosing, the skin of five males and five females for the 2000 mg/kg limit test and the skin of 2 males and 2 females pr group for the definitive LD50 determination was abraded by making four epidermal incisions with a clean needle to produce bleeding. The test material was applied directly onto the exposed skin of the animals. A layer of gauze was wrapped around the animals to cover the dosed area. The animal was wrapped with rubber dam and an Ace bandage to retard evaporation. The test article was held in contact with the skin of the animals for 24-hrs. After that, the test site was washed to remove any remaining material.

Observation were recorded at 2 and 4 hrs after the 24 hrs period of exposure and twice daily thereafter for 14 days. Body weights were recorded weekly and at the study termination. All rabbits were sacrificed by CO2 inhalation od Day 14 and a gross necropsy was performed.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
2 535 mg/kg bw
Based on:
test mat.
95% CL:
1 769 - 3 634
Remarks on result:
other: One of 8 animals died at 1600 mg/kg level, 5 of 8 died at 2500 mg/kg and 6 of 8 died at 4000 mg/kg.
Six of the 10 animals died at 2000 mg/kg. One of the eight animals died at the 1600 mg/kg level, five of eight died at 2500 mg/kg and six of eight died at 4000 mg/kg.
Clinical signs:
other: Signs observed at 2000 mg/kg/day are: diarrhea, semi-prostation, body drop, prostation, abnormal gait, decreased activity and abnormal stance. Signs observed at the 1600, 2500 and 4000 mg/kg levels included: erythema, body drop, decreased activity, decrea
Other findings:
Necropsy of those animals dying on study revelead discolored adrenals and hemorrhages present in the muscle underlying the application site. Necropsy of animals exposed to 1600 mg/kg level, 2500 mg/kg and 4000 mg/kg revealed hemorrhages on muscle underlying the application site and dark fluid present in the bladder. Dried exudate around the oral and nasal cavities was also observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
Based upon the observation made in the acute dermal toxicity test in rabbits, the estimated acute dermal LD50 for phenylethyl alcohol was considered to be 2535 mg/kg with 95% confidence limits of 1769 to 3634 mg/kg.
Executive summary:

The acute dermal toxicity potential of phenylethyl alcohol was investigated using 3 groups of 8 rabbits (4 males and 4 females). The test item was administrated at dose levels of 1600, 2500 and 4000 mg/kg. At all dosage levels the main signs observed were prostration, decreased activity, which disappeared after 4 -5 days from the treatment. Mortaility occurred for 1 of the 8 animals exposed to 1600 mg/kg, and for 6 of 10 animals exposed to 2000 mg/kg for 5 of 8 animals treated with 2500 mg/kg and for 6 of 8 rabbits treated with 4000 mg/kg. In conclusion, the estimated acute dermal LD50 of phenylethyl alcohol was considered to be 2535 mg/kg with 95% confidence limits of 1769 to 3634 mg/kg, under the condition of the study.