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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Justification for type of information:
For the read-across justification see section 13.
Reason / purpose for cross-reference:
read-across source
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.
Specific details on test material used for the study:
- Physical state: oily liquid
- Analytical purity: not given
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)
Route:
intradermal
Vehicle:
other: Ethanol
Concentration / amount:
Challenge: 2.5%
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
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

All test animals and controls showed no skin effects (0%). Lauric acid is not sensitizing in guinea pigs.

Interpretation of results:
GHS criteria not met
Conclusions:
not sensitising
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification