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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 500 mg occlusive epicutaneous
2nd: Induction 500 mg occlusive epicutaneous
3rd: Induction 500 mg occlusive epicutaneous
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1st: Induction 500 mg occlusive epicutaneous
2nd: Induction 500 mg occlusive epicutaneous
3rd: Induction 500 mg 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, D-33176 Borchen
- Age: healthy young adults
- Weight at study initiation: 383 g (mean test); 364 g (mean control)
- Controls: 10 animals
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 50 %; 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: 50 %
- Positive control:
2-mercaptobenzothiazol (2-MCBT, CAS No. 149-30-4) (not concurrent)
Magnusson-Kligman maximization test with 10 test and 2 x 5 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: 5; 10; 30; 50 % 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:
500mg
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: 500mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
500mg
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: 500mg. 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. Higher concentrations were not

homogeneously miscible with vehicle.

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 signs of systemic toxicity were detected during the

observation period.

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

The overall mean body weight increase of 194 g (test group) / 188 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 classification as no effects were observed.