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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)
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1st: Induction 60 % occlusive epicutaneous
2nd: Induction 60 % occlusive epicutaneous
3rd: Induction 60 % occlusive epicutaneous
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1st: Induction 60 % occlusive epicutaneous
2nd: Induction 60 % occlusive epicutaneous
3rd: Induction 60 % occlusive epicutaneous
No. of animals per dose:
20 animals for test
10 animals for control
Details on study design:
TEST ANIMALS:
- Strain: Dunkin-Hartley, Pirbright White, Hsd/Win:DH (SPF)
- Sex: female
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Age: healthy young adults
- Weight at study initiation: 373 g (mean test); 372 g (mean control)
- Controls: 10 animals; treatment: vehicle
ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction:
applied quantity approximately 0.5 g of the homogeneous preparation test
substance / vehicle
- Induction schedule: 3 identical inductions on days 0, 7, and 14:
6 hour occlusive patch (left side), concentration 60 %; then removal of
residual test material
assessment 30 hours after each administration
- Challenge schedule: day 28
two 6 hour occlusive patches (right side), one with test material and one
with vehicle only
subsequent removal of residual test material
assessments 30 and 54 hours after administration
- Concentrations used for challenge: 60 %
- Positive control:
2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4) (not concurrent)
Magnusson-Kligman maximization test with 10 test and 10 control animals
Intracutaneous induction with 2.5 % in corn oil
Occlusive epicutaneous induction with 50 % in corn oil
Occlusive epicutaneous challenge with 50 % in corn oil
EXAMINATIONS
- Grading system: as usual for skin irritation, 0-8 scores possible
- Pilot study: determination of slightly and not skin irritating concentrations
dermal concentrations: 10; 20; 40; 60 % w/w
3 animals each with 4 different concentrations at different sites
6 hour occlusive patch test followed by removal of residual test material
assessment of dermal reactions 30 and 54 hours after administration
- Additional (and identical except for increased body weights) pilot study
during week 4; reason: Increase in body weight might cause differences in
skin sensitivity
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4) (not concurrent)
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
60%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
60%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 20.0.

RESULTS OF PILOT STUDY: None of the applied test substance

concentrations caused primary skin irritation in any of the two pilot studies

30 or 54 hours after administration.

RESULTS OF TEST

- Sensitization reaction: No signs of skin irritation were observed in the

application areas of test and control animals 30 and 54 hours after

administration.

- Clinical signs: No treatment related signs of systemic toxicity were

observed.

1st, 2nd, and 3rd induction: No signs of skin irritation were observed in the

application areas of test and control animals 30 hours after administration.

- Positive control: 10/10 test animals positive, no control animal positive

- Other:

A preparation of 70 % test substance in vehicle could not be mixed

satisfactorily.

The overall mean body weight increase of 176 g (test group) / 171 g

(control group) is normal: no treatment related effect.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No skin sensitising effect shown in the study thus no requirement for classification