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Toxicological information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed acccording to GLP and in full compliance with OECD 406.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
source: Charles River Wiga GmbH, Sulzfeld, Germany
Age: about 20 days
Weight: 384 +/- 12.7 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: For intracutaneous application: dilution in aqua pro injection or dilution in aqua pro injection/Freund’s Complete Adjuvans For epicutaneous application: dilution in purified water.
Concentration / amount:
a) intracutaneous injection: 5 % (v/v)
b) 48 h occlusive bandage for topical induction: 10 % (v/v)
c) topical challenge: 2% (v/v)
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: For intracutaneous application: dilution in aqua pro injection or dilution in aqua pro injection/Freund’s Complete Adjuvans For epicutaneous application: dilution in purified water.
Concentration / amount:
a) intracutaneous injection: 5 % (v/v)
b) 48 h occlusive bandage for topical induction: 10 % (v/v)
c) topical challenge: 2% (v/v)
No. of animals per dose:
5 in control group
10 in treatment group
Details on study design:
In a skin sensitisation test according to Magnusson-Kligman, 10 guinea-pigs were treated with PAA solutions intracutaneously (day 0) and epicutaneously (day 7) for induction and epicutaneously (day 21) for challenge.
Challenge controls:
Day 21: epicutaneous application
Positive control substance(s):
yes
Remarks:
Positive response regularly checked with benzocain.

Results and discussion

Positive control results:
Results of the pre-test are summarised in table 6.1.5/01-1 (below).
After 48h no skin reactions were observed. Skin fold thickness was not different from control group.
After 72h no skin reactions were observed. Skin fold thickness was not different from control group.
Body weight was not influenced by the treatment.

Results of test (except LLNA)

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
10% test vehicle
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
9 animals with grade 1, 1 animals with grade 2
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10% test vehicle. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 9 animals with grade 1, 1 animals with grade 2.
Reading:
rechallenge
Hours after challenge:
72
Group:
test group
Dose level:
10% test vehicle
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
3 animals with grade 1, 1 animals with grade 2
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 10% test vehicle. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 3 animals with grade 1, 1 animals with grade 2.

Any other information on results incl. tables

Results of the Pre-Test

Application method

Con­centra­tion
% (v/v)

Skin reaction after intracutaneous or epicutaneous application

Animal no. 1

Animal no. 2

24h

48h

72h

24h

48h

72h

left

right

left

right

left

right

left

right

left

right

left

right

intracutaneous

5

E2 S

E2 S

E1 S

E1 S

E1 S

E1 S

E3 S

E3 S

E1 S

E1 S

E1 S

E1 S

2

E1 S

E2 S

S

E1 S

0

E1 S

E1 S

E2 S

E1 S

E1 S

E1

E1 S

1

E1 S

E1 S

E1 S

S

E1

S

E1 S

E1 S

E1 S

S

E1

0

0.5

S

S

S

0

0

0

E1

E1

0

0

0

0

epicutaneous

Animal no. 3

Animal no. 4

10

E2

E1

0

E2

E1

0

5

E2

E1

0

E2

0

0

2

E1

0

0

E1

0

0

1

0

0

0

0

0

0

E = erythema grade (1 = discrete or patchy, 2 = moderate and confluent, 3 = intense)

S = swelling

0 = no skin reaction

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions described in the study PAA has no skin sensitising effect.
Executive summary:

In a skin sensitisation test according to Magnusson-Kligman, 10 guinea-pigs were treated with PAA solutions intracutaneously (day 0) and epicutaneously (day 7) for induction and epicutaneously (day 21) for challenge.

None of the animals showed any treatment related skin reaction (erythema, swelling, increased skin fold thickness). Body weights were within the normal range and did not differ from the control group.