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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test carried out by GLP compliant laboratory to recognised validated methods by trained personnel

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
From 5% to 25% by weight of the test substance in propylene glycol
25 microlitres of the suspension were applied daily for three consecutive days
No. of animals per dose:
Four mice per concentration
A control group of 4 mice were treated with propylene glycol alone
Positive control substance(s):
other: phenylacetaldehyde CAS122-78-1

Results and discussion

Positive control results:
At a concentration of 2.5% in propylene glycol, the positive test substance, phenylacetaldehyde, which had been applied to five mice, showed a stimulation index of 18.43 and is known to be a skin sensitiser.

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: At 5%w/w in propylene glycol = 0.77 (negative result) At 10%w/w in propylene glycol = 0.56 (negative result) At 25%w/w in propylene glycol = 0.61 (negative result)

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test material was considered to be a non-sensitiser under the conditions of the test