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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:
27/11/2003 to 15/1/2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
24 April 2002
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
The substance is the Source of the read-across.

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
Nulliparous and non-pregnant mice, weight range of 15 to 23 g, and 8 to 12 weeks old. Free access to food and mains tap water.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10 or 25%
No. of animals per dose:
5
Details on study design:
Preliminary screening suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest concentration. The mice were treated by daily application of 25 microlitres of the test material to the dorsal surface of each ear for three consecutive days.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.72
Test group / Remarks:
5 animals; 5% w/w in acetone/olive oil, 4:1
Key result
Parameter:
SI
Value:
2.42
Test group / Remarks:
5 animals; 10% w/w in acetone/olive oil, 4:1
Key result
Parameter:
SI
Value:
2
Test group / Remarks:
5 animals; 25% w/w in acetone/olive oil, 4:1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Considered to be a non-sensitiser.