Registration Dossier
Registration Dossier
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EC number: 205-778-7 | CAS number: 150-90-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report of the Cosmetic Ingredient Review Expert Panel on the safety assessment of dicarboxylic acids, salts, and esters.
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 012
- Bibliographic source:
- International Journal of Toxicology; 2012 Jul-Aug;31(4 Suppl):5S-76S.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Guinea pig maximisation test was performed to assess the dermal sensitization potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Adipic acid
- EC Number:
- 204-673-3
- EC Name:
- Adipic acid
- Cas Number:
- 124-04-9
- Molecular formula:
- C6H10O4
- IUPAC Name:
- 1, 4-butanedicarboxylic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):adipic acid
- Molecular formula :C6H10O4
- Molecular weight ):146.141g/mole
- Substance type:organic
- Physical state:solid
-Smiles: C(CCCCC(O)=O)(O)=O
-InChI: 1S/C6H10O4/c7-5(8)3-1-2-4-6(9)10/h1-4H2,(H,7,8)(H,9,10)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1% (0.1mL)
- Day(s)/duration:
- 4 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50% (0.05 mL)
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 guinea pigs/group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures: 4
- Exposure period:4 week
- Test groups: 10
- Control group:
- Site: sacral
- Frequency of applications: once a week
- Duration: 4 weeks
- Concentrations: 1% (0.1mL)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: After 2 weeks
- Exposure period: no data available
- Test groups: 10
- Control group: no data
- Site: no data
- Concentrations: 50% (0.05 mL)
- Evaluation (hr after challenge): no data
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 50% (0.05 mL)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitization was observed in treated guinea pigs.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No skin sensitization was observed in treated guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical failed to induce sensitization reactions in the treated guinea pigs. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs.
- Executive summary:
Guinea pig maximisation test was performed to assess the dermal sensitization potential of the test chemical. Group of ten guinea pigs were used for the study..
For induction, 0.1ml of 1% aqueous solution of the test chemical was given as a sacral intradermal injection, once a week for 4 weeks to group of ten guinea pigs . After a rest period of 2 weeks, animals were challenged with 0.05ml of 5% of the test chemical in propylene glycol.
The test chemical failed to induce sensitization reactions in the treated guinea pigs. Hence the test chemical was considered to be not sensitizing to the skin of guinea pigs.
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