Registration Dossier
Registration Dossier
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EC number: 219-648-2 | CAS number: 2491-06-7
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:
- The skin sensitization study of chemical Adipic acid (CAS no: 124-04-9) was conducted in group of ten guinea pigs to assess its skin sensitization potential.
- GLP compliance:
- not specified
- Type of study:
- not specified
- 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
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Adipic acid
- Molecular formula: C6H10O4
- Molecular weight: 146.141 g/mol
- 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)
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 material Adipic acid (CAS no: 124-04-9) was considered to be not sensitizing to the skin of guinea pigs.
- Executive summary:
The skin sensitization study of chemical Adipic acid (CAS no: 124-04-9) was conducted in group of ten guinea pigs to assess its skin sensitization potential.
For induction, 0.1ml of 1% aqueous solution of adipic cid was given as a sacral intradermal injection, once a week for 4 weeks. After a rest period of 2 weeks, animals were challenged with 0.05ml of 5% of adipic acid in propylene glycol.
None of the treated guinea pig induced skin sensitization reaction. Hence the chemical Adipic acid (CAS no: 124-04-9)was considered to be not sensitizing to the skin of guinea pigs.
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