Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
- Principles of method if other than guideline:
- The experiment was conducted according to the method of B. Magnusson and M. Kligman [The Journal of Investigative Dermatology, Volume 52, No. 3 and Allergic Contact Dermatitis in the Guinea Pig., Charles C. Thomas Publisher, Springfield, Illinois, 1970, USA].
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1970. At that time the LLNA method was not available yet. According to ECHA guideline on information requirements a deviation from LLNA test is accepted for in vivo skin sensitisation studies that were carried out before 2017.
Test material
- Reference substance name:
- Lauric acid
- EC Number:
- 205-582-1
- EC Name:
- Lauric acid
- Cas Number:
- 143-07-7
- Molecular formula:
- C12H24O2
- IUPAC Name:
- lauric acid
Constituent 1
- Specific details on test material used for the study:
- - Physical state: oily liquid
- Analytical purity: not given
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-white
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 374 g (test group), 389 g (control group)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Ethanol
- Concentration / amount:
- Challenge: 2.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol
- Concentration / amount:
- Challenge: 2.5%
- No. of animals per dose:
- 20
- Details on study design:
- CHALLENGE EXPOSURE
- Exposure period: 24 hours
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 2.5%
- Evaluation (hr after patch removal): 24 and 48 hours - Challenge controls:
- 10 animals
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
Any other information on results incl. tables
All test animals and controls showed no skin effects (0%). Lauric acid is not sensitizing in guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not sensitising
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