Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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: Non-GLP, non-guideline study, some restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five male and five female animals were used for each of 5 oral dosage levels and held for a 14-day observation period
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Sample number: 41105731

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Madison WI
- Age at study initiation: 7 weeks
- Weight at study initiation: 202-300 g
- Fasting period before study: overnight
- Housing: 5/cage
- Diet: ad libitum, Purina Rodent Chow
- Water: ad libitum
- Acclimation period: 7 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10.0 ml/kg bw
Doses:
Males: 2.55, 2.75, 3.00, 3.57, 5.00 g/kg
Females: 1.30, 1.82, 2.55, 3.57, 5.00 g/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality: 1, 2.5 and 4 hrs after administration and daily thereafter. Weighing: before administration and on day 7 and 14
- Gross necropsy of animals which died: yes
- Gross necropsy of survivors performed: no
Statistics:
Thakur, A.K., and Fezio, W.L., 1891. A computer program for estimating LD50 and its confidence limits using a modified Behrens-Reed-Muench cumulant method. Drug and Chemical Toxicology, 297-305.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2.72 other: g/kg bw
95% CL:
2.52 - 2.93
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2.15 other: g/kg bw
95% CL:
1.61 - 2.89
Mortality:
Males: 2.55 g/kg: 0/5 (0 of 5 animals); 2.75 g/kg: 3/5; 3.57-5.00 g/kg: 5/5
Females: 1.30 g/kg: 0/5; 1.82 g/kg: 2/5; 2.55 g/kg: 3/5; 3.57-5.00 g/kg: 5/5
Clinical signs:
not reported
Body weight:
no differences in body weight observed between dosage levels
Gross pathology:
In the animals which died histopathological lesions were observed mainly in the gastro-intestinal tract, primarily in the stomach.

Applicant's summary and conclusion