Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1956
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
other: LD50
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Age at study initiation: 5 to 6 weeks

- Weight at study initiation: 90-120 grams

- Fasting period before study: not fasted

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
T52-003: 10% dilution in corn oil
Details on oral exposure:
VEHICLE

- Concentration in vehicle: as a 10% dilution


MAXIMUM DOSE VOLUME APPLIED: ca. 5 for 7.95 g/kg dose and ca. 8ml for 3.98 g/kg dose


Doses:
7950 and 3980 mg/kg
No. of animals per sex per dose:
3.98 g/kg: 5 rats
7.95 g/kg: 4 rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: no data available

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data available
Statistics:
Thompson's method of calculating the median-effective dose (LD50) was applied to the 14-day mortality data.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
5 600 mg/kg bw
Based on:
other: median-effect dose, calculated from the 14-day mortality data
Remarks on result:
other: No range is given because there was 100%  mortality at 7.95 g/kg and 100% survival at 3.98 g/kg.
Mortality:
All animals administered the higher dose died. No mortalities were seen at the lower dose.
Clinical signs:
3.98 g/kg: no data available
At 7.95 g/kg: Violent convulsions followed the administration of the doses and death ensued in a few hours.
Body weight:
For the surviving animals, weight change was as follows; +37 to +68g
Gross pathology:
3.98 g/kg: no data available
At 7.95 g/kg: Lungs were hemorrhaged, livers and kidneys mottled and adrenals slightly congested at autopsy.
Other findings:
No data available.

Any other information on results incl. tables

Table 1: Number of animals dead and time range within which mortality occurred

 Dose
(mg/kg
bw)

Mortality (# dead/total)

Time range of deaths (day)

Male

Female

Combined

3.98

 0/5

 -

 0/5

 -

7.95

 4/4

 4/4

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with male Wistar rats, the LD50 was determined to be 5600 mg/kg. The study was similar to OECD 401 but pre-dates GLP.