Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted in 2000.

Test material

Constituent 1
Chemical structure
Reference substance name:
Peracetic acid
EC Number:
201-186-8
EC Name:
Peracetic acid
Cas Number:
79-21-0
Molecular formula:
C2H4O3
IUPAC Name:
Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions

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
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
Not specified
Total no. in group:
0
Clinical observations:
Not specified
Remarks on result:
positive indication of skin sensitisation
Remarks:
Positive response regularly checked with benzocain.
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
positive control
Dose level:
Not specified
Total no. in group:
0
Clinical observations:
Not specified
Remarks on result:
positive indication of skin sensitisation
Remarks:
Positive response regularly checked with benzocain.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0%
Total no. in group:
5
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Remarks:
Negative control results not specified
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0%
Total no. in group:
5
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Remarks:
Negative control results not specified
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
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:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
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:
positive indication of skin sensitisation

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:
GHS criteria not met
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.