Registration Dossier
Registration Dossier
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EC number: 222-264-8 | CAS number: 3398-33-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21/03/2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This test was already available (it was performed for cosmetic regulation compliance), before REACH regulation requirements.
Test material
- Reference substance name:
- Sodium undec-10-enoate
- EC Number:
- 222-264-8
- EC Name:
- Sodium undec-10-enoate
- Cas Number:
- 3398-33-2
- Molecular formula:
- C11H20O2.Na
- IUPAC Name:
- sodium undec-10-enoate
Constituent 1
- Specific details on test material used for the study:
- sodium undec-10-enoate in a 33.2% aqueous solution
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 ml of test substance at 0.1%
- Day(s)/duration:
- D1/1 day
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, open
- Vehicle:
- physiological saline
- Concentration / amount:
- 50%
- Day(s)/duration:
- D9/1 day
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5 ml of the test substance diluted at 50%
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Thirty guinea-pigs (15 males and 15 females) were allocated to 2 groups : a control group (5 males and 5 females) and a treated group (10 males and 10 females)
- Details on study design:
- The sensitization potential of the test substance was evaluated after a 10 days induction period, during which the animals were treated with the vehicle (control group) or the test substance (treated group).
After a 15 days rest period, a challenge cutaneous application of 0.5ml of the vehicle (left flank) and the test substance diluted at 50% (right flank) was administered to all animals. The substsances were held in contact with the skin for 24h by means of an occlusive dressing. The cutaneous reactions were evaluated at the challenge application site, 24 and 48h after removal of the dressing. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptoms or mortality were observed throughout the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptoms or mortality were observed throughout the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no symptoms or mortality were observed throughout the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no symptoms or mortality were observed throughout the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the maximization method of magnusson and kligman, no cutaneous reactions due to any sensitization process of the substance sodium undec-10-enoate (in a 33.2% aqueous solution) were observed in the guinea-pig.
- Executive summary:
The skin sensitization study was performed according to the OECD 409 guideline.
The substance is considered as non sensitizer in the guinea pig.
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