Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Purity unknown, limited description of the method, test period unknown

Data source

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

Materials and methods

Test guideline
Guideline:
other: Barail test with intracutaneous injection
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
other: Gelb-Silber

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: Sesame oil
Duration of treatment / exposure:
Daily exposures over five days of 0.5mL of 5 or 10% C.I. Pigment Orange 5 in sesame oil to clipped rapid skin.
Observation period:
5 days
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 5 days
Score:
ca. 0
Remarks on result:
other: Daily exposures over five days with 0.5mL of 5 or 10% of C.I. Pigment Orange 5 in sesame oil to clipped rabbit skin didn’t show any skin reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Daily exposures over five days with 0.5mL of 5 or 10% of C.I. Pigment Orange 5 in sesame oil to clipped rabbit skin didn’t show any skin reactions.