Peracetic acid

Endpoint summary

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 the seventeenth time in Regulation (EU) 2021/849.