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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
mouse local lymphnode assay (LLNA)

Test material

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

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 2.5, 5, 10%
No. of animals per dose:
5 per dose
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
6.09
Test group / Remarks:
2.5%
Parameter:
SI
Value:
10.31
Test group / Remarks:
5%
Parameter:
SI
Value:
9.11
Test group / Remarks:
10%
Parameter:
EC3
Remarks on result:
not determinable

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
A dermal sensitization test was conducted with mice to determine the potential for IR9804 to produce sensitization after repeated topical application.
Based on the results of this study, the test substance is considered positive for dermal sensitization potential in the LLNA.
Since all dose levels induces a SI > 3.0, the EC3 could not be calculated.