Registration Dossier
Registration Dossier
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EC number: 266-097-9 | CAS number: 66063-15-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according EU/OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 4-chloro-N-cyclopentylbenzylamine
- EC Number:
- 266-097-9
- EC Name:
- 4-chloro-N-cyclopentylbenzylamine
- Cas Number:
- 66063-15-8
- Molecular formula:
- C12H16ClN
- IUPAC Name:
- N-[(4-chlorophenyl)methyl]cyclopentanamine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal: 1% N-(4-Chlorbenzyl)-N-cyclopentylamin formulated in corn oil
epicuntaneous: 25% N-(4-Chlorbenzyl)-N-cyclopentylamin formulated in corn oil
challenge: 1% N-(4-Chlorbenzyl)-N-cyclopentylamin formulated in corn oil
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal: 1% N-(4-Chlorbenzyl)-N-cyclopentylamin formulated in corn oil
epicuntaneous: 25% N-(4-Chlorbenzyl)-N-cyclopentylamin formulated in corn oil
challenge: 1% N-(4-Chlorbenzyl)-N-cyclopentylamin formulated in corn oil
- No. of animals per dose:
- test group: 10 anmimals
control group: 5 animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight localized redness
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Slight localized redness.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight localized redness
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Slight localized redness.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The challenge using a 1% test substance formulation led to slight skin effects (grade 1) in 1/10 animals in the treatment group and in 1/5 animals in the control group. As the effect in the test substance group was comparable with the effect in the control group, this skin effects were interpreted to be irritation reactions.
- Executive summary:
Under the conditions of the maximization test and with respect to the evaluation criteria the test substance therefore thus exhibits no skin-sensitization potential.
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