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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

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