Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
other: Gelb-Silber

Test system

Vehicle:
other: Sesame oil
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
Single exposure of 0.1 mL of 5 or 10% suspension of C.I. Pigment Orange 5 in sesame oil
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 to 7 hours
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight redness after 3 to 7 hours was observed for three rabbits exposed to the highest concentration of 10% of C.I. Pigment Orange 5 in Sesame oil. The redness was not observed after 24 hours, and the rabbit of 5% dilution showed no reaction.
Other effects:
Very slight redness after 3 to 7 hours was observed for three rabbits exposed to the highest concentration of 10% of C.I. Pigment Orange 5 in Sesame oil. The redness was not observed after 24 hours, and the rabbit of 5% dilution showed no reaction.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA