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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-860-4 | CAS number: 100-52-7
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:
- other: Study run to a method comparable with current guidelines, no GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Acceptable guinea pig maximisation test equivalent or simialr to OECD Guideline 406.
Test material
- Reference substance name:
- Benzaldehyde
- EC Number:
- 202-860-4
- EC Name:
- Benzaldehyde
- Cas Number:
- 100-52-7
- Molecular formula:
- C7H6O
- IUPAC Name:
- benzaldehyde
- Details on test material:
- Batch No.: not specified
Purity: not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- None stated
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Paraffin oil (Intradermal Induction) and petrolatum (Topical Induction and Challenge)
- Concentration / amount:
- Intradermal Induction: 3.0%
Topical Induction: 15.0%
Challenge: 7.0%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Paraffin oil (Intradermal Induction) and petrolatum (Topical Induction and Challenge)
- Concentration / amount:
- Intradermal Induction: 3.0%
Topical Induction: 15.0%
Challenge: 7.0%
- No. of animals per dose:
- 10 animals per dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 for Intradermal Induction and 10 for Topical Induction
- Exposure period: Intradermal Induction: 1 day; Topica1 Induction: 48 h, occluded
- Test groups: 10 animals per group for two groups
- Control group: yes
- Frequency of applications: once daily
- Concentrations: 3.0% (in paraffin oil) and 15.0% (in petrolatum)
B. CHALLENGE EXPOSURE
- No. of exposures: 20
- Exposure period: 24 h, occluded
- Test groups: 10 animals per group for two groups
- Control group: yes
- Concentrations: 7.0 (in petrolatum)
No additional data - Challenge controls:
- None stated
- Positive control substance(s):
- yes
- Remarks:
- isoeugenol
Results and discussion
- Positive control results:
- The isoeugenol gave a 100% response to Guinea Pig.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Challenge I
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 7.0% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challange I. . Hours after challenge: 48.0. Group: test group. Dose level: 7.0% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- other: Challenge II
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 7.0% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- One animal appeared equivocal result.
- Remarks on result:
- other: Reading: other: Challenge II. . Hours after challenge: 48.0. Group: test group. Dose level: 7.0% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: One animal appeared equivocal result..
- Group:
- negative control
- Remarks on result:
- other: No results provided for the negative control
- Key result
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The isoeugenol gave a 100% response to Guinea Pig.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance appeared to be not sensitizing in Guinea pig maximization Test.
- Executive summary:
This Guinea pig maximization test was conducted according to a method which similar to OECD Guideline 406.
The test substance appeared to be not sensitizing in Guinea pig maximization Test.
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.
