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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: based on product (0.15% PAA)
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.