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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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
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)
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.
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)
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
















































































































































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


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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitising potential of peracetic acid was investigated in a skin sensitisation test according to Magnusson-Kligman. Guinea-pigs were treated with peracetic acid solutions intracutaneously (5% peracetic acid) and epicutaneously (10% peracetic acid) for induction and epicutaneously (2% peracetic acid) for challenge. None of the animals showed any treatment related skin reaction (erythema, swelling, increased skin fold thickness). Based on the results peracetic acid is therefore not considered to be potential skin sensitiser.


 


The same results was also find in three other studies performed according to guidelines and GLP, where peracetic acid was tested at concentrations of 5% or 12& respectively (Kuhn, 1986; Kuhn, 1996; Freeman, 1991). Based on the results, peracetic acid can be regarded as not sensitizing to skin.


 


In a publication two cases of potential sensitisation by inhalation peracetic acid-hydrogen peroxide mixtures were reported and further examined (Cristofari-Marquand, 2007). The results of the examinations led to the conclusion that occupational prolonged exposure to vapours of peracetic acid-hydrogen peroxide mixtures was observed to cause symptoms which were the consequence of a sustained irritation process rather than a real asthmatic reaction caused by sensitization.


 


Overall the data show no evidence of a sensitizing potential of peracetic acid.


 


Justification for selection of skin sensitisation endpoint: Reliable guideline study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data on sensitization of peracetic acid do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification according to EU Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217.