Methyl 12-hydroxyoctadecanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Remarks:

summary of experiment work

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Judged to be scientifically reliable and appropriate for risk assessment by the Expert Panel of dermatologists and scientists at the Cosmetics Ingredient Review, Washington, DC., U.S.A.

Data source

Reference

Reference Type:

publication

Title:

Amended Final Report on the Safety Assessment of Hydroxystearic Acid

Author:

Johnson W

Year:

1999

Bibliographic source:

Int. J Toxicol.18(Supp1): 1-10

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

12-hydroxystearic acid

EC Number:

203-366-1

EC Name:

12-hydroxystearic acid

Cas Number:

106-14-9

Molecular formula:

C18H36O3

IUPAC Name:

12-hydroxyoctadecanoic acid

impurity 1

Reference substance name:

Palmitic acid

EC Number:

200-312-9

EC Name:

Palmitic acid

Cas Number:

57-10-3

Molecular formula:

C16H32O2

IUPAC Name:

palmitic acid

impurity 2

Reference substance name:

Stearic acid

EC Number:

200-313-4

EC Name:

Stearic acid

Cas Number:

57-11-4

Molecular formula:

C18H36O2

IUPAC Name:

stearic acid

impurity 3

Reference substance name:

Castor oil

EC Number:

232-293-8

EC Name:

Castor oil

Cas Number:

8001-79-4

Molecular formula:

UVCB

IUPAC Name:

castor oil

Test material form:

solid

Remarks:

soft waxy solid or gel

Details on test material:

Melting point of 82 deg C; also reported as 75-77 deg C. Crystallizes from alcohol (ethanol). UV absorption maximum at 295 nm. Additional impurity reports: polyvinyl stearate, up to 2.0% (CASRN not reported, but may be 9003-95-6).

Specific details on test material used for the study:

Purity 86%

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

10, 25, 50%

No. of animals per dose:

5

Details on study design:

Test material in DMSO was applied to the dorsal surface of each ear of the mice, daily for 3 days. On day 5, tritiated thymidine (3HTdR) was administered via the tail vein.

Positive control substance(s):

not specified

Results and discussion

In vivo (LLNA)

Results

Key result

Parameter:

EC3

Value:

16

Remarks on result:

other: positive

Remarks:

Sensitiser at 16%

Any other information on results incl. tables

None of the animals died, and there were no signs of toxicity. The EC3 value was calculated to be 16% Hydroxystearic acid was considered a sensitiser.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

The test substance (12-HSA) was tested in an LLNA using tritiated thymidine in female CBA mice. The results were positive, and 12-hydroxystearic acid was considered a sensitiser. The EC3 value was calculated to be 16%. This summary data reflects the opinion of the CIR Expert Panel that the data are valid and informative, adding to a weight of evidence approach for the sensitisation potential of the test substance.