Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-266-8 | CAS number: 105-06-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance monograph for the test chemical
- Author:
- D.L.J. Opdyke
- Year:
- 1 974
- Bibliographic source:
- Food and Cosmetics Toxicology. Vol. 12, Pg. 393, 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Human Maximization test was performed to determine the dermal sensitization potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- 4-methylanisole
- EC Number:
- 203-253-7
- EC Name:
- 4-methylanisole
- Cas Number:
- 104-93-8
- Molecular formula:
- C8H10O
- IUPAC Name:
- 1-methoxy-4-methylbenzene
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): para-Cresyl methyl ether- Molecular formula: C8H10O- Molecular weight: 122.166 g/mol- Substance type: organic - Physical state: Solid- InChI: 1S/C8H10O/c1-7-3-5-8(9-2)6-4-7/h3-6H,1-2H3-- Smiles: COc1ccc(C)cc1
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25 volunteers
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No skin sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- No skin sensitization reaction were observed in treated volunteers .Hence the test chemical was considered to be not sensitizing to humans.
- Executive summary:
Human Maximization test was performed to determine the dermal sensitization potential of the test chemical
The test chemical 2% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of sensitization(duration of exposure, observation period not mentioned).
No skin sensitization reaction were observed in treated volunteers .Hence the test chemical was considered to be not sensitizing to humans.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
