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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from similar mixture/product
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference Type:
review article or handbook
Amended Final Report on the Safety Assessment of Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Germ Oil, Rice Bran Acid, Oryza Sativa (Rice) Bran Wax, Hydrogenated Rice Bran Wax, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sat
Bibliographic source:
International Journal of Toxicology - CIR database
Report date:

Materials and methods

Principles of method if other than guideline:
Data are extracted from the 2006 review of the International Journal of Toxicology about the assessment of rice derivates. Since the study reported is dated back to 1999 (Cosmepar. 1999a. Primary cutaneous irritation test on the albino rabbit. Unpublished data submitted by CTFA, June 20, 2002. 16 pages) we assume that it was performed according to OECD 406
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time of the study, it didn't use to perform LLNA method

Test material

Constituent 1
Reference substance name:
Hydrolyzed Rice Protein
Hydrolyzed Rice Protein
Test material form:

In vivo test system

Test animals

guinea pig

Study design: in vivo (non-LLNA)

No. of animals per dose:
15 (5 controls + 10 treated)
Details on study design:
No reactions were observed in a preliminary test, so the maximum non-irritant concentration was “undiluted” test material.
A maximization approach was used to examine sensitization. Five control animals received intradermal injections (0.1 ml) of Freund’s complete adjuvant (50% in saline) at two sites and 0.9% saline at two sites. Ten test animals received intradermal injections (0.1 ml) of Freund’s complete adjuvant (50% in saline) at two sites, 50% Hydrolyzed Rice Protein in saline at two sites, and a 50:50 mixture of the Freund’s and the test material at two sites. At day 7 the treated areas were painted with a 10% solution of sodium lauryl sulfate. At day 8, control animals received a topical application of 0.5 ml saline and the treatment group received 0.5 ml undiluted Hydrolyzed Rice Protein under occlusive dressing for 48 h.
An untreated area of the back was shaved and 0.25 ml of undiluted Hydrolyzed Rice Protein was applied over a 4-cm2 area under a semiocclusive dressing for 24 h
Positive control substance(s):
1% alcohol solution of 1-chloro-2,4-dinitrobenzene

Results and discussion

In vivo (non-LLNA)

Key result
Remarks on result:
no indication of skin sensitisation
No dermal reactions of any kind were observed in control or treated animals

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The substance is not sensitive for skin according to criteria set out in Regulation (EC) n. 1272/2008 (CLP)