Registration Dossier
Registration Dossier
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EC number: 214-371-3 | CAS number: 1123-25-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 2 000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- 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:
- 1-methylcyclohexane-1-carboxylic acid
- EC Number:
- 214-371-3
- EC Name:
- 1-methylcyclohexane-1-carboxylic acid
- Cas Number:
- 1123-25-7
- Molecular formula:
- C8H14O2
- IUPAC Name:
- 1-methylcyclohexane-1-carboxylic acid
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
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 50% (= 250 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
Challengeopen allclose all
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5% (= 20 mg test item/animal)
Topical induction: 50% (= 250 mg test item/animal)
Challenge: 25% (= 125 mg test item/animal)
- No. of animals per dose:
- test item group: 10
control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
In a Guinea Pig Maximization Test the test substance was examined in female guinea pigs for its skin sensitizing properties. The intradermal induction was performed using a 5% test item concentration, and the topical induction was performed with a 50% test item concentration. The test item was formulated in polyethylene glycol 400 to yield a solution. After the intradermal induction the animals in the control group and in the test item group showed strong effects up to encrustation at the injection sites of the first induction. The challenge using a 25% test item formulation led to no skin effects in the treatment group and the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In summary, by comparing the results in the treatment group and in the control group under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits no skin-sensitization potential.
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