Rice oligopeptides

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from similar mixture/product

Adequacy of study:

key study

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

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

Year:

2006

Bibliographic source:

International Journal of Toxicology - CIR database

Report date:

2006

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 Unpublished data submitted by CTFA, June 20, 2002. 16 pages) we assume that it was performed according to OECD 406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

Test material information

Constituent 1

Reference substance name:

Hydrolyzed Rice Protein

IUPAC Name:

Hydrolyzed Rice Protein

Test material form:

liquid

In vivo test system

Test animals

Species:

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):

yes

Remarks:

1% alcohol solution of 1-chloro-2,4-dinitrobenzene

Results and discussion

In vivo (non-LLNA)

Results

Key result

Remarks on result:

no indication of skin sensitisation

Remarks:

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

Conclusions:

The substance is not sensitive for skin according to criteria set out in Regulation (EC) n. 1272/2008 (CLP)