Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
reported as "other guideline: Annex V (Maximisation test)"
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed in 1986 before the Local Lymph Node Assay (LLNA; TG 429) was adopted (2002).

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: intradermal: sesame oil and adjuvant mixture, epidermal & challenge exposure: vaseline
Concentration / amount:
- Concentration of test material and vehicle used at induction:
1% in sesame oil and in adjuvant mixture (intradermal).
20% in vaseline (epidermal).

- Concentration of test material and vehicle used for each challenge:
10% in vaseline.
Challengeopen allclose all
Route:
other: no data
Vehicle:
other: intradermal: sesame oil and adjuvant mixture, epidermal & challenge exposure: vaseline
Concentration / amount:
- Concentration of test material and vehicle used at induction:
1% in sesame oil and in adjuvant mixture (intradermal).
20% in vaseline (epidermal).

- Concentration of test material and vehicle used for each challenge:
10% in vaseline.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
The test incorporated pretreatment with 10% sodium lauryl sulfate prior to epidermal induction.

Results and discussion

In vivo (non-LLNA)

Results
Remarks on result:
other: quantitative result not determined; no signs of irritation during induction; no evidence of sensitisation of each challenge concentration

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
On the basis of these results and under the experimental conditions the test substance did not appear to possess sensitising capacity.
Executive summary:

The test substance was tested to be non sensitising to the skin of guinea pigs in a GLP study according to EU Method B.6.