Registration Dossier
Registration Dossier
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EC number: 210-296-5 | CAS number: 612-16-8
Acute Toxicity: dermal
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:
- 1 990
- 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
- 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 substance name:
- 2-phenoxyethanol
- EC Number:
- 204-589-7
- EC Name:
- 2-phenoxyethanol
- Cas Number:
- 122-99-6
- Molecular formula:
- C8H10O2
- IUPAC Name:
- 1-hydroxy-2-phenoxyethane
- 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
Constituent 1
- 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 or test system 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:
- other: 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.
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