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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:
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:
2012
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

Constituent 1
Chemical structure
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
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:
No clinical signs of toxicity were observed in any of the animals.
Body weight:
no data available
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.