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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1st December 1997 - July 3, 1998
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
in vivo data was already available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
none

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
INDUCTION EXPOSURE:
Day 0: Induction by intradermal injection: Two pairs of intradermal injections of 0.1 ml each were administered to each animal.
Control group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: Aqua pro injectione
Injection 3: the third injection was not necessary because the chosen vehicle was Aqua pro injectione
Dose group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: 10% solution (w/v) of the test article in Aqua pro injectione
Injection 3: 10% emulsion (w/v) of the test article in 50:50 mixture (v/v) Aqua pro injectione and FCA

Day 7: Induction by dermal application
Control group: Filter papers (2x4 cm) were soaked in 0.1 g of white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
Dose group:
Filter papers (2x4 cm) were soaked in 0.1 g of the 75:25 mixture (w/w) of test article and white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.

CHALLENGE EXPOSURE:
Day 21: Challenge by dermal application: each animal: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
INDUCTION EXPOSURE:
Day 0: Induction by intradermal injection: Two pairs of intradermal injections of 0.1 ml each were administered to each animal.
Control group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: Aqua pro injectione
Injection 3: the third injection was not necessary because the chosen vehicle was Aqua pro injectione
Dose group:
Injection 1: 50:50 mixture (v/v) of FCA and Aqua pro injectione
Injection 2: 10% solution (w/v) of the test article in Aqua pro injectione
Injection 3: 10% emulsion (w/v) of the test article in 50:50 mixture (v/v) Aqua pro injectione and FCA

Day 7: Induction by dermal application
Control group: Filter papers (2x4 cm) were soaked in 0.1 g of white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.
Dose group:
Filter papers (2x4 cm) were soaked in 0.1 g of the 75:25 mixture (w/w) of test article and white vaseline. One paper each was then placed on the skin on both sides of the body and covered with an occlusive dressing for 48 hours.

CHALLENGE EXPOSURE:
Day 21: Challenge by dermal application: each animal: 1.0 g sample of either vehicle or the 75:25 mixture (w/w) of test article and white vaseline
No. of animals per dose:
10 males (test group)
5 males (control group)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75:25 mixture (w/w) of test article and white vaseline
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10% benzocaine in liquid paraffine
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
skin reactoin
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
According to the classification system for skin reactions of the EEC Directive 93/21 the test item has no skin sensitisation effect.
Executive summary:

Guidance on information requirements and chemical safety assessment, Chapter R.7a, p.279: Endpoint specific

guidance, Guidance for the implementation of REACH,May 2008, ECHA: Read-across from structurally related substances can be used to classify the substance as not sensitising to the skin (Integrated testing strategy (ITS) for skin sensitisation).

Important considerations for the read-across approach is:

 ·        BLANCOLEN HP has similar physico-chemical properties likeBRUGGOLITE FF6

 ·        BLANCOLEN HP is a constituent of BRUGGOLITE FF6

 ·        The structural similarities between the two chemicals.

The weight of evidence analysis (taking into account the evaluation of skin sensitisation of BRUGGOLITE FF6 which is not a skin sensitisizer), following ITS, indicates that the test item is devoid of any skin irritation.