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Skin sensitisation

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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:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
LLNA was not adopted as a OECD test guideline at the time of study conduct
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
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)
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1st: Induction 500 mg on Day 0 for 6 h
2nd: Induction 500 mg on Day 7 for 6 h
3rd: Induction 500 mg on Day 15 for 6 h
Day(s)/duration:
Day 0, 7 and 14 / 6h treatment each
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1st challange: 500 mg
Day(s)/duration:
Day 30 / 6 h treatment, assessment 30 and 54 h after administration
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 animals for test
10 animals for control
Details on study design:
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)
Positive control results:
Positive control: 10/10 test animals positive
Reading:
1st reading
Hours after challenge:
30
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of systemic toxicity were detected during the observation period.
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
test chemical
Dose level:
500 mg
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of systemic toxicity were detected during the observation period.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
0 mg
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of systemic toxicity were detected during the observation period.
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
0 mg
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of systemic toxicity were detected during the observation period.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
50 % in corn oil
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
50 % in corn oil
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

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:
GHS criteria not met
Conclusions:
Based on the available study according to OECD 406, the Test Item is considered as not skin sensitizing.
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.

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