Registration Dossier
Registration Dossier
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EC number: 200-068-3 | CAS number: 50-85-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety Assessment of Alkyl Benzoates as Used in Cosmetics
- Author:
- Becker LC, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler D, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Andersen FA.
- Year:
- 2 012
- Bibliographic source:
- International Journal of Toxicology, November/December 2012 vol. 31 no. 6 suppl 342S-372S
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Skin irritation study was conducted on the clipped dorsum and external surface of the outer ear of male new Zealand albino rabbits to assess the skin irritation potential of test chemical Methylbenzoate (CAS No: 93-58-3)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methyl benzoate
- EC Number:
- 202-259-7
- EC Name:
- Methyl benzoate
- Cas Number:
- 93-58-3
- Molecular formula:
- C8H8O2
- IUPAC Name:
- Methylbenzoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Methylbenzoate
- Molecular formula: C8H8O2
- Molecular weight: 136.149 g/mol
- Substance type: Organic
- Physical state: Liquid
-Smiles : COC(=O)c1ccccc1
- InChI: 1S/C8H8O2/c1-10-8(9)7-5-3-2-4-6-7/h2-6H,1H3
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Methylbenzoate
- Molecular formula: C8H8O2
- Molecular weight: 136.149 g/mol
- Substance type: Organic
- Physical state: Liquid
-Smiles : COC(=O)c1ccccc1
- InChI: 1S/C8H8O2/c1-10-8(9)7-5-3-2-4-6-7/h2-6H,1H3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No data available
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Amount :0.5ml on clipped dorsum and 0.2ml on external surface of the outer ear
concentration applied: 100% - Duration of treatment / exposure:
- 6 days
- Observation period:
- 6 days
- Number of animals:
- 14
- Details on study design:
- - Area of exposure: dorsum and external surface of the outer ear
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 6 d
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- rated as Grade 1
- Irritant / corrosive response data:
- On the dorsum there were marked cellular reactions and dermal edema beginning on day 2 followed by dermal hemorrhage, desquamated crust, and thickening of the malpighian stratum beginning on day 5. On the inner ear, there was slight hyperkeratosis on day 6.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Methylbenzoate (CAS No: 93-58-3) was considered to be irritating to the clipped dorsum and external surface of the outer ear of male new Zealand albino rabbits as it was rated grade 1.
- Executive summary:
Skin irritation study of test chemical Methylbenzoate (CAS No: 93-58-3)was carried out in 14male New Zealand albino rabbitsto observe its irritation potential.
Undiluted methyl benzoate was applied to the clipped dorsum (0.5mL) and external surface of the outer ear (0.2mL)of 14 male New Zealand albino rabbits The rabbits were observed for 6 days for signs of irritation.On the dorsum there were marked cellular reactions and dermal edema beginning on day 2 followed by dermal hemorrhage, desquamated crust, and thickening of the malpighian stratum beginning on day 5 were observed and on the inner ear, there was slight hyperkeratosis on day 6.
Since the test chemical was rated as grade 1,Methylbenzoate (CAS No: 93-58-3) was considered to be irritating to the clipped dorsum and external surface of the outer ear of male new Zealand albino rabbits.
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