Peracetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

equivalent or similar to

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

equivalent or similar to

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals and environmental conditions:

- Strain: Tac:N[SD]fBR
- Source: Taconic Farms, Germantown, NY, USA
- Age: young adult
- Weight at study initiation: 233-262 g (males), 209-239 g (females)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Application volume: 1.2-1.3 ml (males); 1.0-1.2 ml (females)
- Doses per time period: single dose
- Volume administered or concentration: The test material, as a 0.15 % use dilution in deionized water, was introduced directly into the stomach of each animal by means of a ball-tipped intubation needle.

Doses:

5000 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: The animals were observed for mortality and clinical signs at 0.5, 1, 2, 3, 4 and 6 hours on the day of dosing and twice daily thereafter for 13 day; on day 14 were observed once. Body weights were taken on the day of dosing and again on days 7 and 14. After the study the animals were submitted to gross necropsy.

Statistics:

Not applicable, only one dose (limit test)

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: based on product (0.15% PAA)

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7.5 mg/kg bw

Remarks on result:

other: based on PAA

Mortality:

There were no deaths.

Clinical signs:

All rats remained healthy during the study and all rats gained weight by day 14 of the study.

Gross pathology:

There were no gross internal lesions observed in any animal at necropsy.

Applicant's summary and conclusion

Conclusions:

The test material was considered to be practically non-toxic; LD50 greater than 5000 mg/kg bw corresponding to greater than 7.5 mg peracetic acid/kg bw (no lethal effect at maximal dose)

Executive summary:

In an acute oral toxicity study 10 rats (5 males and 5 females) were dosed with a peracetic acid solution (0.15 %) at a dose level of 5000 mg/kg bw. Observations for clinical signs and toxicity were made after 0.5, 1, 2, 3, 4 and 6 hours and twice daily until sacrifice on day 14. Body weights were recorded on days 0, 7 and 14. A gross necropsy was performed on all animals. There were no mortalities or clinical signs. All rats remained healthy and gained weight during the study. At necropsy, no gross lesions were observed. Hence, the LD50 is greater than 5000 mg/kg bw corresponding to greater than 7.5 mg peracetic acid/kg bw.