Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class 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:
Source : Buckshire Corp. Perkasie, PA 18944, USA.
Age/weight at study initiation : 200-293 g
Number of animals per group : Five rats per test group
Control animals : No

The animals were housed and maintained in accordance with standards set forth in the Guide for the care and use of laboratory animals. The rats were acclimated to the laboratory for at least 7 days prior to dosing. Animals were individually identified by ear punch. Each cage was identified with a cage card displaying the project number, sex, date dosed, and responsible technician's initials.

Husbandry Conditions
Temperature: 19 -25°C.
Relative Humidity: 40 -70%.
Light: 12hour light/dark cycle.
Diet: ad libitum. Based on our current knowledge, no contaminants are known to be in this diet or water which might be expected to interfere with the objectives of the study.
Caging: Stainless steel elevated wire mesh flooring, 1 rat/cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2.01, 3.01, 3.70, 5.00, 7.50 and 11.25 g/kg bw
No. of animals per sex per dose:
50
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 630 mg/kg bw
Clinical signs:
Clinical signs of intoxication were yellow anogenital staining, ruffled fur, lethargy and sometimes dark nasal (and ocular) staining and ruffled skin.
Gross pathology:
Gross pathological examination of animals which died showed a dark liquid in the lower gastrointestinal tract. Mainly at the higher dosage groups additional changes like clear or dark muzzle staining, haemorrhagic lungs, yellow genital staining, pale liver and/or kidney and gas in the lower gastrointestinal tract were observed in one or the other case.

Any other information on results incl. tables

NOEL for clinical signs is 2.01 g/kg b.w.

Acute oral LD50:

male rats as                         4.57 g/kg (3.65 – 5.73 g/kg)

female rats as                     7.22 g/kg (4.94 – 10.55 g/kg)

rats (both sexes) as            5.63 g/kg ( 4.40 – 7.2 g/kg)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article, when administered as supplied to male albino rats, has an acute oral LD50 of 4.57g/Kg of active ingredent with 95% confidence limits from 3.65 to 5.73 g/Kg of active ingredient.
The test article, when administered as supplied to female albino rats, has an acute oral LD50 of 7.22 g/Kg of active ingredent with 95% confidence limits from 4.94 to 0.55 g/Kg of active ingredient.
The test article, when administered as supplied to male and female albin rats combined, has an acute oral LD50 of 5.63 g/Kg of active ingredent with 95% confidence limits from 4.40 to 7.20 g/Kg of activee ingredient.
The no effect level for clinical signs is 2.01 g/Kg.
Piperonyl ^Butoxide is of low acute oral toxicity.