Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test parameters documented do not totally comply with a testing guideline but they are sufficient to accept the data, even if pathology was not performed. The complete justification for the Read Across approach is reported in the Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
In order to determine the dose/response relationship of the test substance, groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif RAI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100 g
- Housing: housed in groups of 5 in macrolon cages (Size3)
- Fasting period before study: animals having been fasted overnight
- Diet and water: animals were fed a standard diet of Nafag ad libitum and had free access of drinking water.
- Acclimation period: acclimatized in laboratories for at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 12-hour light period

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Concentration in vehicle: 10 % or 50 %

Doses:
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
Groups of 5 male and 5 female rats
Control animals:
no
Details on study design:
Symptoms and mortality after administration were recorded during an observation period of 8 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed up to the dose of 15000 mg/kg bw
Clinical signs:
No symptoms at doses of 1000 to 3000 mg/kg . Reduction of spontaneous motility was observed after 3 hours after dose administration of 10000 mg/kg . No symptoms have not been recorded after 24 hours. At the dose of 15000 mg/kg, reduction of spontaneous motility, hypoventilation and slight ataxia were observed.
Body weight:
No weight loss was observed for all tested doses

Any other information on results incl. tables

Route of admin. Dose mg/kg Vehicle Concentration (%) Mortality Bodyweight (g) Symptoms
male female % Day of test pre-test day 8 of test
p.o. 1000 dist. water 10 0/5 0/5 0 - 100 170 none
p.o. 3000 dist. water 10 0/5 0/5 0 - 100 171 none
p.o. 10000 dist. water 50 0/5 0/5 0 - 100 168 reduction in spontaneous motility > 3 hours After 24 hours, no symptoms
p.o. 15000 dist. water 50 0/5 0/5 0 - 100 157 ditto, hypoventilation, slight ataxia

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the test substance was practically devoid of toxicity at each dose level.
The acute oral LD50 in rats was established to be > 15000 mg/kg bw.
Executive summary:

The oral acute toxicity study was performed according to an internal method: groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.

The acute oral LD50 in rats was established to be > 15000 mg/kg bw.