Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-11-23 to 1985-12-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Yellowish high viscosity liquid
100%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
- Strain: Wistar (Bor: WISW (SPF TNO))
- Source: Winkelmann, Borchen (Germany)
- Weight at study initiation: females 153 g, males 206 g (mean)
- Fastening before administration: 16 hours
Environmental conditions: - Feed: R 10 complete feed for rats (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times per hour
- Illumination: 12 hour light/dark rhythm

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test item was administered undiluted. Rats were fasted for 16 hours and then received a single oral dose by gavage: Volume 9.488 mL/kg bw.
Doses:
- Doses: 10000 mg/kg body weight, volume: 9.488 mL/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Post dose observation period: 14 days
EXAMINATIONS:
- body weight: before and on days 1, 7, 14 after treatment
- clinical signs: up to 6 hours after treatment, then daily
- gross pathology at the end of investigation
Statistics:
not necessarry

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
After 1-2 hours some animals had ruffled fur ans one animal diuresis, after 4 hours ruffled fur was observed in 9 animals and diuresis in 10 animals, and later some of them showed staggering gait, slight ataxia and sedation, diarrhoe and a squatting position.While after 24 hours diuresis was stillobserved in 9 animals, all of them were free from the symptoms of poisoning after 48 hours.
Body weight:
Increase of body weight was unaffected by the treatment.
Gross pathology:
Dissection at the end of the experiment revealed hyperaemia of the gastric mucosa in 5 animals and additionally in one animal partial hyperaemia of the small intestinal mucosa
Other findings:
no further information

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the acute toxicity of the test item in male and female rats is greater than 10000 mg/kg body weight.
Executive summary:

In a determination of the acute oral toxicity in a limit test of test item 5 male and 5 female rats received a single oral dose by gavage of 10000 mg/kg body weight. After 1-2 hours some animals had ruffled fur and one animal diuresis, after 4 hours ruffled fur was observed in 9 animals and diuresis in 10 animals, and later some of them showed staggering gait, slight ataxia and sedation, diarrhoe and a squatting position.While after 24 hours diuresis was still observed in 9 animals, all of them were free from the symptoms of poisoning after 48 hours. The increase of body weight was unaffected by the treatment. Dissection at the end of the experiment revealed hyperaemia of the gastric mucosa in 5 animals and additionally in one animal partial hyperaemia of the small intestinal mucosa

Under the conditions of this study, the acute toxicity of test item in male and female rats is greater than 10000 mg/kg body weight.