Registration Dossier

Administrative data

Description of key information

Skin:
Peracetic acid < 1%: not irritating (human studies, Draize-Test)
1% < peracetic acid < 3%: irritating (OECD 404, rabbit)
3% < peracetic acid > 5%: corrosive (OECD 404, rabbit)
Eyes:
Peracetic acid < 1%: not irritating (OECD 405)
1% < peracetic acid < 3%: irritating
peracetic acid >= 3%: corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin:

The skin irritation potential of peracetic acid has been investigated in the rabbit by testing dilutions of equilibrium solutions of peracetic acid containing about 0.2 to > 35% of peracetic acid.

The results demonstrate that peracetic acid at actual topical concentrations of less than 1% is neither irritating nor corrosive to skin, while peracetic acid at concentrations of 3% and higher causes burns or severe burns of the skin (Duprat, 1974; Mayer, 1988; Zechel, 1988). When tested at concentrations up to 0.34% peracetic acid in the equilibrium mixture are not or only slightly irritating (Duprat et al., 1974). At peracetic acid concentrations between 3% and 5% in the equilibrium mixture, the results of the studies of Duprat et al. (1974) and Janssen et al. (1987) revealed destruction of the skin was noted later than 1 hour after administration. In the study of Mayer (1988), corrosion of the skin was noted 45 minutes after application of an equilibrium mixture containing 5% of while with a concentration of 10% peracetic acid in the equilibrium mixture, skin corrosion was reported 3 minutes after application (Zechel, 1988).

In addition to the animal studies, there are publications on the use of peracetic acid as disinfection agent available where the irritating potential of peracetic acidin solution were evaluated.

In one publication, the cytotoxic and irritating potential of peracetic acid in humans with a view to its local tolerance when used as a disinfectant for hand washing procedures applied by surgeons was investigated (Kramer, 1987). The material tested was a Wofasteril product containing 0.5 % of peracetic acid. In this small but representative collective of surgeons, 3 of 15 surgeons developed immediately erythema and 6 of 15 surgeons developed dermatosis of the hands after 7 days following daily soaping, brushing and disinfection of skin with peracetic acid at a concentration of 0.5 %. The investigations performed demonstrated that peracetic acid applied as Wofasteril caused dermal irritation reactions in a third of health care workers.

In another publication a Patch test (48 h, occlusive) was carried out with peracetic acid in a product, which was tested in dilutions of 1:33 (1500 mg/L peracetic acid), 1:20 (2500 mg/L peracetic acid) and 1:15 (correct value should be 3300 mg/L). Based on the results it was concluded that up to 2500 mg/L peracetic acid (corresponding to an about 0.25 % solution) is non irritating. At 3300 mg/L peracetic acid (corresponding to an about 0.33 % solution) is a mild irritant (French, 1993).

Kretschmer et al. (1971) described the effects of diluted peracetic acid solutions used as an aerosol (0.8 % peracetic acid), as a disinfectant for human skin (0.08 or 0.2 % peracetic acid) and for the treatment of a recurrent, pruritic epidermitis (0.1 % peracetic acid).

As a consequence of the overall data on skin irritation and corrosion, the concentration-dependent skin irritation/corrosion potential identified in various studies is reflected in the specific concentrations limits defined in the legal classification & labelling of peracetic acid.

Eye:

The results of studies on the potential eye irritation/corrosion demonstrated that at higher peracetic acid concentrations, all formulations caused severe and irreversible damage to the rabbit eye leading to a classification and labelling as a severe eye irritant. Highly diluted formulations exerted only mildly irritating effects which were demonstrated to be completely reversible.

In a study performed according to GLP and OECD guideline 405 peracetic acid at 0.15 % use dilution was instilled into the test eyes of six rabbits at a dose of 0.1 mL (Freeman, 1991). Each eye was held closed for approximately one second after administration. The eyes were then assessed for irritation at 1, 24, 48 and 72 hours as well as day 4, respectively. Mild to moderate chemosis and severe discharge were noted in all eyes 1 hours post dosing. At the 24-hour scoring, slight corneal opacities, slight to moderate redness and chemosis and mild to severe discharge were noted in all eyes. The slight irritation gradually resolved and was completely resolved by study day 4.

However, at concentrations of ≥3%, peracetic acid has been demonstrated to be corrosive to the skin which in parallel qualifies for a classification into category 1 for eye damage according the GHS classification system. This is supported by the results of the eye irritation study where application of a 17% peracetic acid led to corrosive effects (Cascieri, 1983).

As a consequence, the concentration-dependent skin irritation/corrosion potential identified in various studies is reflected in the specific concentrations limits defined in the legal classification & labelling of peracetic acid.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

The available data on skin and eye irritation/corrosion of peracetic acid meet the criteria for classification according to Regulation (EC) 1272/2008 resulting in classification with respective concentrations limits as follows:

Route Concentration Classification
Skin C < 1% No classification
1 <= C < 3% Skin Irrit. 2, H315
3 <=C < 5% Skin Corr. 1C, H314
5 <= C < 10% Skin Corr. 1B, H314
C =>10% Skin Corr. 1A, H314
Eye C < 1% No classification
1 <= C < 3% Eye Irrit. 2, H319
C => 3% Eye Dam. 1, H318