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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 Unpublished data submitted by CTFA, June 20, 2002. 16 pages) we assume that it was performed according to OECD 404
GLP compliance:
not specified

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.5 ml of undiluted test material
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h, 72h
Number of animals:
3
Details on study design:
An aqueous solution of Hydrolyzed Rice Protein was tested for dermal irritation in albino rabbits (Cosmepar 1999a). Undi- luted test material (0.5 ml) was applied to the normal shaved skin of the left side of the backs of three male New Zealand albino rabbits (2 to 2.5 kg). The nontreated shaved skin on the left side was the control. Gauze patches were applied over the sites and held in place with adhesive strips (OMNIFIX⃝R ), over which was placed a plastic restrictive jacket. After 4 h, the adhesive strip and gauze were removed and the site rinsed with distilled water. Irritation was determined at 1, 24, 48, and 72 h. No signs of erythema, edema, desquamation, or necrosis were seen at any time in any animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: desquamation and necrosis
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

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