Peracetic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Harlan CPB Zeist, The Netherlands
- Strain: Hsd/Cpb:WU Wistar
- Age: Not indicated
- Weight: 169-194 g (males), 145-172 g (females)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

- Application volume: 2 mL/kg bw (2000 mg/kg bw)
- Area covered: aliquots of the test material were taken and applied over a strip gauze of about 40 cm^2

Doses:

2000 mg/kg of product (= 17.8 mg/kg of peracetic acid)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of post-exposure period: 14 days
- Removal of test substance: yes, after 24 hours the gauze patches were peeled off
- Examinations: Clinical signs and mortality (0.5, 1, 2, 3, 4 and 6 hours after dosing and then twice daily), local irritation on days 1, 3, 7 and 14, body weights (days 0, 7 and 14), gross necropsy at study termination.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: based on product (0.89% PAA), only dose tested; no mortalities

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 17.8 mg/kg bw

Remarks on result:

other: based on PAA (0.89% in product)

Mortality:

No mortalities.

Clinical signs:

other: Signs of mild irritation in most animals (white and/or red spots on treated skin, complete recovery after 12 days)

Gross pathology:

One female showed a maculate thymus. This was not considered to be a treatment related effect. No other findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 after dermal application of the test material is greater than 2000 mg/kg bw (corresponding to greater than 17.8 mg/kg bw peracetic acid). No classification with respect to acute dermal toxicity is required.

Executive summary:

In a study to assess the acute dermal toxicity of PAA a single dermal dose of 2000 mg/kg bw was applied under an occlusive dressing to the shaved intact skin of groups of five male and five female Wistar rats. The animals were weighed one day before dosing, at the day of dosing and at 2, 7 and 14 days after treatment. Any sign of intoxication occurring during the 14-day observation period was recorded. Gross post-mortem examination was done in all rats at the end of the 14-day observation period.

None of the rats died within the 14-day observation period. White and/or red spots were noted on the treated skin after removal of the bandage. These spots got brown and encrusted during the observation period. The skin symptoms subsided after 12 days. No other clinical signs were observed. Transient weight loss was observed in both sexes in the first few days of the study. Thereafter body weight gain appeared to be normal. This transient weight loss was considered to be partly a consequence of stress induced by the bandaging procedure (the study design) and partly consequence of stress induced by the irritating properties of the test material. At autopsy, no treatment related abnormalities were recorded for any of the animals.