Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (maximisation)
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: Albino Guinea Pig (Dunkin Hartley strain)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
A) 1:1 (w/w) mixture of Freund's Complete Adjuvant with
water for injection.

B) 0.2% test substance in propylene glycol

C) 1:1 (w/w) mixture of the test substance and of Freund's
Complete Adjuvant.

Concentration of test material and vehicle used for each challenge:
50% test substance and propylene glycol, using patch test
plasters.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
A) 1:1 (w/w) mixture of Freund's Complete Adjuvant with
water for injection.

B) 0.2% test substance in propylene glycol

C) 1:1 (w/w) mixture of the test substance and of Freund's
Complete Adjuvant.

Concentration of test material and vehicle used for each challenge:
50% test substance and propylene glycol, using patch test
plasters.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: .2 %

Signs of irritation during induction:
The dermal reactions caused by the intradermal injections
were assessed for irritation. Necrosis was seen at the
injection sites. This was considered to be caused by the
vehicle rather than by the test substance.

No signs of irritation were observed up to the highest
epidermally tested concentration. Therefore, a 10% SDS
solution was applied to provoke a mild inflammatory
reaction.

Evidence of sensitisation of each challenge concentration:
At 50% test substance concentration, 7 out of 10 animals
showed a response indicative of sensitisation. No skin
reactions were evident in the control animals.  These
results indicate a sensitisation rate of 70 per cent.

Other observations:
Yellow staining was observed at the test substance treated
skin sites, 24 and 48 hours after challenge. This staining
did not hamper scoring.

Applicant's summary and conclusion

Interpretation of results:
other: irritant