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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from Publication.

Data source

Reference
Reference Type:
publication
Title:
9 Final Report on the Safety Assessment of Phenoxyethanol
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1990
Bibliographic source:
Journal of the American College of Toxicology, Volume: 9 issue: 2, page(s): 259-277, March 1, 1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as metioned below
Principles of method if other than guideline:
Acute Dermal toxicity study of Phenoxyethanol (122-99-6) in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Phenoxyethanol
InChI: 1S/C8H10O2/c9-6-7-10-8-4-2-1-3-5-8/h1-5,9H,6-7H2
Smiles: c1(ccccc1)OCCO
- Molecular formula (if other than submission substance):C8H10O2
- Molecular weight (if other than submission substance):138.165 g/mol
- Substance type:Organic
Specific details on test material used for the study:
Name: Phenoxyethanol
InChI: 1S/C8H10O2/c9-6-7-10-8-4-2-1-3-5-8/h1-5,9H,6-7H2
Smiles: c1(ccccc1)OCCO
- Molecular formula (if other than submission substance):C8H10O2
- Molecular weight (if other than submission substance):138.165 g/mol
- Substance type:Organic

Test animals

Species:
rat
Strain:
other: CFY rats
Sex:
male/female
Details on test animals and environmental conditions:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsolumbar region
- % coverage: 10% of the total body surface
Duration of exposure:
24 h
Doses:
Doses ranged from 1000-22200 mg/kg
No. of animals per sex per dose:
Total = 10
5 rats of each sex (Male/Female)
Control animals:
not specified
Details on study design:
- Frequency of observations and weighing: Animals were observed for mortality and gross examinations.
- Necropsy of survivors performed: yes
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
13 000 mg/kg bw
Based on:
test mat.
95% CL:
10 300 - 15 400
Remarks on result:
other: 50% mortality was observed
Mortality:
Mortality occurred at 21-48 h after dosing.
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
Hemorrhagic lungs were observed at necropsy.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be 13000 mg/kg with confidential limit of 10300-15400 mg/kg bw, when CFY strain male/female rats were treated with Phenoxyethanol (122-99-6) by dermal application to the dorsolumbar region under an occlusive patch.
Executive summary:

Acute dermal toxicity study of undiluted Phenoxyethanol (122-99-6) was conducted in 10 CFY strain male/female rats at the concentration ranged from 1000-22200 mg/kg bw. The Phenoxyethanol was applied to the dorsolumbar region under an occlusive patch such that 10% of the total body surface was covered. The test material was remained in contact with the skin for 24 h. Animals were observed for mortality and gross examinations. Mortality occurred at 21-48 h after dosing. Hemorrhagic lungs were observed at necropsy. Therefore, LD50 was considered to be 13000 mg/kg with confidential limit of 10300-15400 mg/kg bw, when CFY strain male/female rats were treated with Phenoxyethanol by dermal application to the dorsolumbar region under an occlusive patch.