Registration Dossier
Registration Dossier
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EC number: 204-582-9 | CAS number: 122-91-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 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 (2012) S502–S506
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- An ocular irritation study was performed in four female SPF albino rabbits for test chemical p-anisyl acetate (CAS No: 104-21-2) in order to determine its irritancy potency.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-methoxybenzyl acetate
- EC Number:
- 203-185-8
- EC Name:
- p-methoxybenzyl acetate
- Cas Number:
- 104-21-2
- IUPAC Name:
- 4-methoxybenzyl acetate
- Test material form:
- other: clear colorless to very pale yellow liquid
- Details on test material:
- - Name of test material (as cited in study report): p- Anisyl acetate
- Molecular formula (if other than submission substance): C10-H12-O3
- Molecular weight (if other than submission substance): 180.202
- Substance type: Organic
- Physical state: Liquid
- Purity: No data available
- Impurities (identity and concentrations): No data available
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
- Smiles: c1(ccc(OC)cc1)COC(C)=O
- InChI: 1S/C10H12O3/c1-8(11)13-7-9-3-5-10(12-2)6-4-9/h3-6H,7H2,1-2H3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF Albino
- Details on test animals or tissues and environmental conditions:
- Sex: Female
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Amount- 0.1mL aliquot
concentration applied: 100% - Duration of treatment / exposure:
- 72 hrs.
- Observation period (in vivo):
- 1, 24, 48 and 72 hrs.
- Number of animals or in vitro replicates:
- 4 (female)
- Details on study design:
- - Area of exposure: left eye
- % coverage: No data available
- Type of wrap if used: No data available
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: 1, 24, 48 and 72 hrs.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Conjuctive irritation
- Basis:
- mean
- Time point:
- other: 1 hr
- Reversibility:
- not specified
- Remarks on result:
- other: Slight to moderate conjunctive irritation (4/4) was observed 1 h after application.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All effects were reversible within 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The test material p-anisyl acetate (CAS No: 104-21-2) was considered to be not irritating in four female SPF albino rabbits.
- Executive summary:
An ocular irritation study was performed in four female SPF albino rabbits for test chemical p-anisyl acetate (CAS No: 104-21-2) in order to determine its irritancy potency.
A 0.1 ml aliquot of undiluted p-anisyl acetate was instilled into the left eye then gently closed for 1 s. The untreated right eye of each animal served as a control. Observations were made at 1, 24, 48 and 72 h. Slight to moderate conjunctive irritation (4/4) was observed 1 hour after application. All effects were reversible within 48 h.
As all the observed effects were not persisted after 48 hours, the chemical p-anisyl acetate (CAS No: 104-21-2) was considered to be not irritating infour female SPF albino rabbits.
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