Registration Dossier
Registration Dossier
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EC number: 222-619-7 | CAS number: 3558-60-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 journals.
Data source
Reference
- Reference Type:
- publication
- Title:
- Monographs of Fragrance Raw Materials
- Author:
- D.L.J Opdyke
- Year:
- 1 982
- Bibliographic source:
- Food and Chemical Toxicology, 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human Maximization test
- Principles of method if other than guideline:
- A human maximization test was carried out to assess the dermal sensitization potential of the test chemical.
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- (2-methoxyethyl)benzene
- EC Number:
- 222-619-7
- EC Name:
- (2-methoxyethyl)benzene
- Cas Number:
- 3558-60-9
- Molecular formula:
- C9-H12-O
- IUPAC Name:
- (2-methoxyethyl)benzene
- Test material form:
- liquid
- Details on test material:
- - Name of test material: Benzene(-2-methoxyethyl)
- Molecular formula: C9H12O
- Molecular weight: 136.193 g/mole
- Smiles : COCCc1ccccc1
- Inchl: InChI=1/C9H12O/c1-10-8-7-9-5-3-2-4-6-9/h2-6H,7-8H2,1H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% in petrolatum
- Day(s)/duration:
- no data available
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 8% in petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 24 hours
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- no signs of dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 24 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin. - Executive summary:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 24 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 24human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin.
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