Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1971
Reference Type:
secondary source
Title:
Final Report on the Safety Assessment of Squalane and Squalene
Author:
CIR Expert panel
Year:
1982
Bibliographic source:
International Journal of Toxicology 1982 1: 37

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Draize test
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml (undiluited)
Duration of treatment / exposure:
24 hours
Observation period:
no data
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h
Score:
ca. 0.29
Max. score:
8
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the procedure of Draize, undiluted Squalene (0.5 ml) was applied to the clipped skin of three rabbits for 24 hours. The test material was practically nonirritating.
Executive summary:

According to the procedure of Draize, undiluted Squalene (0.5 ml) was applied to the clipped skin of three rabbits for 24 hours. The test material was practically nonirritating.