Registration Dossier
Registration Dossier
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: 202-347-5 | CAS number: 94-60-0
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: summary data
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Kodak footpad method
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- Study was conducted before the LLNA requirement was in place.
Test material
- Reference substance name:
- Cyclohexane-1,4-dicarboxylic acid
- EC Number:
- 214-068-6
- EC Name:
- Cyclohexane-1,4-dicarboxylic acid
- Cas Number:
- 1076-97-7
- Molecular formula:
- C8H12O4
- IUPAC Name:
- cyclohexane-1,4-dicarboxylic acid
- Details on test material:
- 0.05 mL of a 1.0% solution in Freund's Complete Adjuvant
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Challenge
- Route:
- intradermal
- No. of animals per dose:
- 10
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Group:
- other: Freund's only
- Dose level:
- 0.1 % in acetone/dioxane/guinea pig fat (7:2:1)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- all animals appeared normal
- Remarks on result:
- other: Reading: rechallenge. Group: other: Freund's only. Dose level: 0.1 % in acetone/dioxane/guinea pig fat (7:2:1). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: all animals appeared normal.
- Reading:
- rechallenge
- Group:
- other: 1% cpd. in Freund's
- Dose level:
- 0.1% in acetone/dioxane/guinea pig fat (7:2:1)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- all animals appeared normal
- Remarks on result:
- other: Reading: rechallenge. Group: other: 1% cpd. in Freund's. Dose level: 0.1% in acetone/dioxane/guinea pig fat (7:2:1). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: all animals appeared normal.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test compound has a low potential for causing human sensitizaiton. No reaction was noted in either the induced or control groups when challenged
- Executive summary:
The test compound has a low potential for causing human sensitizaiton. No reaction was noted in either the induced or control groups when challenged
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.
