Registration Dossier
Registration Dossier
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EC number: 204-578-7 | CAS number: 122-84-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance material review on p-anisyl acetate
- Author:
- D. McGinty, C.S. Letizia, A.M. Api
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology 50,S502-S506
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- p-Anisyl acetate was applied topically for 24 h at a dose of 5 g/kg to 6 New Zealand albino rabbits followed by a 14 day observation period.
- GLP compliance:
- not specified
- Test type:
- other: no data available
- Limit test:
- no
Test material
- Reference substance name:
- p-methoxybenzyl acetate
- EC Number:
- 203-185-8
- EC Name:
- p-methoxybenzyl acetate
- Cas Number:
- 104-21-2
- Molecular formula:
- C10H12O3
- IUPAC Name:
- 4-methoxybenzyl acetate
- Test material form:
- other: clear colorless to very pale yellow liquid
- Details on test material:
- - Name of test material :p- Anisyl acetate
- Molecular formula :C10-H12-O3
- Molecular weight :180.202
- Substance type:Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):p- Anisyl acetate
- Molecular formula :C10-H12-O3
- Molecular weight :180.202
- Substance type:Organic
- Physical state: Liquid
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino rabbits
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The application sites of three of the rabbits were intact prior to application while the other three rabbits had slightly abraded sites. The test material was covered with a rubber sleeve and Webril padding.
- Duration of exposure:
- 24 hrs
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 6 animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality and histopathology observations - Statistics:
- no data available
Results and discussion
- Preliminary study:
- no data available
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- no mortality was observed at dose 5000 mg/kg bw
- Clinical signs:
- other: No clinical signs of toxicity were observed in any of the animals.
- Gross pathology:
- Necropsy showed one animal with dark red specks on the lungs
- Other findings:
- Well-defined to moderate erythema was seen in all rabbits and edema ranged from slight to severe in five rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The median lethal dose (LD50) value for p-anisyl acetate by dermal administration was considered to be >5000 mg/kg in New Zealand albino rabbits.
- Executive summary:
p-Anisyl acetate was applied topically for 24 h at a dose of 5000mg/ kg to 6 New Zealand albino rabbits followed by a 14 day observation period.
Well-defined to moderate erythema was seen in all rabbits and edema ranged from slight to severe in five rabbits. There was no morality or clinical signs of toxicity in any of the animals. Necropsy showed one animal with dark red specks on the lungs
The acute dermal LD50 of p-anisyl acetate is considered to be >5000mg/Kg. This value indicates that the substance shall not be classified for Acute Dermal toxicity as per the CLP criteria.
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