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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Short report. Main features of study design given. Also assessed by OECD.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Similar to limit test but higher dose is used.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wistar derived
- Weight at study initiation: 200-300 grams
- Fasting period before study: 24hours
- Housing: mesh bottom cages
- Diet (e.g. ad libitum): Available after dosage
Water (e.g. ad libitum): Available after dosage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% in aqueous solution
Doses:
Single dose of 20,000 mg/kg of the test material.
No. of animals per sex per dose:
5 males, 5 females (10).
Control animals:
no
Details on study design:
Ten young adult albino rats weighing between 200-300 grams equally distributed into five males and five females were housed in mesh-bottom cages and fasted 24 hours prior to administrating a single dose of 20,000 mg/kg of the test material. Food and water were available ad libitum after dosage. The animals were observed daily for 14 days following adminsitration of the test material and deaths were recorded.

Results and discussion

Preliminary study:
No mortality was observed at the dosage level of 20,000 mg/kg of body weight. Gross examination at autopsy revealed sporadic visceral hemorrhage.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Mortality:
None
Clinical signs:
No information on clinical signs.
Body weight:
No information on body weights.
Gross pathology:
Gross examination at autopsy revleaed sporadic visceral hemorrhage.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
The approximate acute oral LD50 for TPP in rats is >20,000 mg/kg of body weight.
Executive summary:

In an acute oral toxicity test in rats, ten young adult albino rats weighing between 200-300 grams equally distributed into five males and five females were housed in mesh-bottom cages and fasted 24 hours prior to administrating a single dose of 20,000 mg/kg of the test material TPP (in 25% aqueous solution). The dose was administered via intragastric intubation. Food and water were available ad libitum after dosage. The animals were observed daily for 14 days following administration of the test material and deaths were recorded. No mortality was observed at the administered dose. Gross examination at autopsy revealed sporadic visceral hemorrhage. The approximate acute oral LD50 obtained for the test material TPP is >20,000 mg/kg of body weight.