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EC number: 201-186-8
CAS number: 79-21-0
Results of the Pre-Test
Skin reaction after intracutaneous or epicutaneous application
Animal no. 1
Animal no. 2
Animal no. 3
Animal no. 4
E = erythema grade (1 = discrete or patchy, 2 = moderate and confluent, 3 = intense)
S = swelling
0 = no skin reaction
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.
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
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.
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