Registration Dossier
Registration Dossier
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EC number: 449-430-4 | CAS number: 99189-60-3 1,1-CYCLOHEXANE DIACETIC ACID MONOAMIDE (CAM); 1,1-CYCLOHEXANEDIACETIC ACID MONOAMIDE
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1,1-cyclohexanediacetic acid monoamide
- EC Number:
- 449-430-4
- EC Name:
- 1,1-cyclohexanediacetic acid monoamide
- Cas Number:
- 99189-60-3
- Molecular formula:
- C10H17NO3
- IUPAC Name:
- 2-[1-(carbamoylmethyl)cyclohexyl]acetic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Intradermal injections: 5, 2.5, 1, 0.5, 0.25 and 0.1 w/v in suspension in paraffin oil
Sensitisation Phase (topical application): 25% in paraffin oil
Challenge (topical application): 25% in paraffin oil
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- paraffin oil
- Concentration / amount:
- Intradermal injections: 5, 2.5, 1, 0.5, 0.25 and 0.1 w/v in suspension in paraffin oil
Sensitisation Phase (topical application): 25% in paraffin oil
Challenge (topical application): 25% in paraffin oil
- No. of animals per dose:
- Preliminary study: 6 males.
Main study: treated group of 10 males and a negative control group of 5 males.
Positive control group: 5 males.
Results and discussion
Any other information on results incl. tables
No irritation reaction was noted at times 24 and 458 hours in animals of the negative control group, and in animals treated during the challenge phase with the test substance at the maximum non irritant concentration.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance is free of any sensitising capacity in the male Guinea pig.
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