Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, no GLP; short report, females only

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 %
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: no data
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
balance disorder and prone position.
feces showed a yellow discoloration
Body weight:
no effects
Gross pathology:
no effects
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose (LD50) after single oral administration to female rats is greater than 5000 mg/kg body weight.
Executive summary:

The test substance, a yellow powder, was administered by oral gavage formulated as a 25% suspension in sesame oil at a single dose of 5.000 mg/kg body weight to 10 female SPF-Wistar-rats (strain: Hoe:WISKf (SPF 71) weighing 190-210g (average weight 201g).

The test system with female rats was chosen, because no differences in sensitivity between sexes were found in preliminary studies. Food was withheld from 16 h before to 2 h after dosing.

The observation period following treatment lasted for 14 days. During this time the animals were weighed weekly, and fed with laboratory diet ALTROMIN 1324 (Altromin GmbH, Lage/Lippe) and tap water ad libitum. Animals were kept in plastic cages on woodshaves.

At the end of the observation period the animals were sacrificed after narcotisation, dissected and examined for macroscopically visible changes.

The study was performed between 1 September 1977 and 16 September 1977.

Results:

None of the 10 rats died after dosing 5000 mg/kg body weight. After administration the animals showed balance disorder and prone position. The weight gains during the observation period were normal in all the rats. After administration the excreted feces showed a yellow discoloration. The animals killed at the end of the observation period showed no macroscopically visible changes.

Due to the experimental design an exact determination of the LD 50 was not possible. However the median lethal dose (LD50) after single oral administration to female rats is definitely greater than 5000 mg/kg body weight.