Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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: The study was conducted comparable to EU Guideline.
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
yes
Remarks:
No positive control animals were used, different vehicles were used for induction and challenge exposure.
GLP compliance:
no
Type of study:
Buehler test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Redfern Animal Breeders, Brenchley, Kent
- Age at study initiation: young
- Weight at study initiation: 300-400 g
Route:
other: epicutaneous
Vehicle:
other: induction: aqueous ethanol, challenge: acetone
Concentration / amount:
concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone
Route:
other: epicutaneous
Vehicle:
other: induction: aqueous ethanol, challenge: acetone
Concentration / amount:
concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone
No. of animals per dose:
20 (10 male and 10 female)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 14 days
- Test groups: 20 animals
- Control group: 10 animals
- Frequency of applications: weekly intervals
- Duration: 6 hours
- Concentrations: 0.1 % (w/v)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction application (on Day 28)
- Exposure period: one application (6 h duration)
- Concentrations: 0.1 % (w/v)
- Evaluation (hr after challenge): 24 and 48

Challenge controls:
no data
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 % (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 % (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A skin sensitization study was conducted on Guinea pigs (Dunkin-Hartley) in a Bühler test. 20 animals were used for testing the substance and 10 further animals were used as control. The test item was applied topically at a concentration of 0.1 % (w/v). For the induction applications, aqueous ethanol and for the challenge applications acetone was used as vehicle. 3 Induction exposures were conducted at weekly intervals and one challenge application was performed. The skin was examined for reactions 24 and 48 hours after patch removal and no reactions were found. Therefore, the test item was considered not to be a skin sensitizer.


Migrated from Short description of key information:
The test substance was found to be not skin sensitising at a non-irritant concentration.

Justification for selection of skin sensitisation endpoint:
only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance was shown to be not skin sensitising at a non-irritant concentration and is therefore not to be classified for skin sensitisation under Regulation (EC) No 1272/2008 (CLP).