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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

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 test was done before LLNA as first-choice method for in vivo testing was set into force.

Test material

Constituent 1
Chemical structure
Reference substance name:
Lauric acid
EC Number:
205-582-1
EC Name:
Lauric acid
Cas Number:
143-07-7
Molecular formula:
C12H24O2
IUPAC Name:
dodecanoic acid

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
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
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
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
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
Group:
positive control
Remarks on result:
not measured/tested
Group:
negative control
Remarks on result:
not measured/tested

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:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified