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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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. 1999b. Ocular irritation test. Unpublished data submitted by CTFA, June 20, 2002) we assume that it was performed according to OECD 405


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 / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
96h
Observation period (in vivo):
1h, 24h, 48h, 72h, 96h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Results
Irritation parameter:
other: all irritant reactions
Remarks on result:
no indication of irritation
Remarks:
Eye examinations were conducted at 1, 24, 48, 72, and 96 h. No reactions of any sort were found in either eye of each animal

Applicant's summary and conclusion

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