Peracetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Comparable to guideline study with acceptable restrictions (Only 2 dose levels; no LD50 determined; purpose: determination of approximative oral toxicity.)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Only 2 dose levels were tested. No LD50 was determined

Principles of method if other than guideline:

Preliminary study to determine the approximate oral toxicity of the test material. Only 2 dose levels were tested. No LD50 was determined

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Strain: Tac:N[SD]fBR
- Source: Taconic Farms, Germantown, NY, USA
- Age: Young adult
- Weight at study initiation: 340-360 g (males), 233-262 g (females)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Doses per time period: Single dose
- Application volume: Not stated, calculated to 0.0442 and 0.442 mL/kg bw based on the specific gravity of the test material (1.13 g/mL)

Doses:

50 and 500 mg/kg of the product

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Post-exposure period: 14 days
- Examinations: mortality, clinical signs, body weights, necropsy
- The animals were observed for mortality and clinical signs at approximately 3 hours after administration on the day of dosing and daily thereafter for 14 days. Body weights were taken on the day of dosing and again on day 7 and 14.

Statistics:

LD50 was not determined.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

50 - 500 mg/kg bw

Remarks on result:

other: based on product (35% PAA) (mortality: 10/10 at 500 mg/kg bw; 1/10 at 50 mg/kg bw)

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

17.5 - 175 mg/kg bw

Remarks on result:

other: based on PAA

Mortality:

All rats receiving 500 mg/kg died withing 3 days of dosing. One male rat receiving 50.0 mg/kg died on day 13.

Clinical signs:

other: Dyspnea, oral discharge, chromorhinorrhea, decreased locomotion

Gross pathology:

Surviving animals had no gross lesions. Gross lesions among decedents included blood filled stomachs and intestines, consolidated lung (1 rat), white livers, spleens, kidneys and stomachs.

Other findings:

No sex-specific differences were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this study, the test material is temporarily approximated to be moderately toxic when orally administered undiluted to Sprague-Dawley rats.
Based on the information provided in this study and taking into account the results reported, the test material containing 35% peracetic acid has to be considered as harmful if swallowed (Xn, R22).

Executive summary:

To determine the approximate and temporary oral toxicity of the test material groups of 5 male and 5 female rats per group were orally dosed with 35 % peracetic acid undiluted at dosage levels of 50 and 500 mg/kg bw. Observations for toxicity were conducted at approximately 3 hours after dosing and daily thereafter for 14 days. Body weights were recorded on days 0, 7 and 14 of the study. A gross necropsy was performed on all animals.

All rats of the high dose group died within 3 days. One male rat of the low dose died on day 13. The predominant clinical signs observed were dyspnea, oral discharge, chromorhinorrhea, decreased locomotion. All survivors gained weight during the study. Internal gross necropsy findings among decedents included blood filled stomachs and intestines, livers, spleens, kidneys and stomachs which appeared white on the surface, and a consolidated lung in one rat. Animals which were sacrificed on day 14 appeared normal at necropsy.

No LD50 value was determined. Based on the mortality rates, the LD50 is between 50 - 500 mg/kg bw corresponding to 17.5 - 175 mg peracetic acid/kg bw.