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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Methodology comparable to internationally accepted guidelines
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: FAT 20063/D TE
Lot: BS-BOP 01-15
Appearance: Dark blue powder
Specific details on test material used for the study:
None

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF) strain
Sex:
male/female
Details on test animals and environmental conditions:
Healthy random bred rats of the Tif: RAIf (SPF) strain (7-8 weeks old) raised on the premises were used for this experiment. They were kept at a room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days. Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3 ), individually marked with picric acid.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
carboxymethyl-ce11ulose 2 % (w/v) in distilled water
Details on oral exposure:
FAT-20'063/B was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Volume (ml/kg body-weight): 20

Animals fasted overnight were treated by single oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.
Doses:
5000 mg/kg bw
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: Observations of mortality and clinical signs at 1, 2, 3, 5 and 24 hrs, and daily thereafter for 14 days; Weighing on days 1, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
Sedation, dyspnoea, ruffled furs, diarrhoea, and curved body position were observed. The animals recovered within 8 days.
Body weight:
No effect on body weight gains was seen.
Gross pathology:
No substance related gross organ changes were seen.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was determined to have a LD50 of >5000 mg/kg bw.
Executive summary:

The acute toxicity of the test substance was evaluated in a limit test conducted according to the methodology equivalent to OECD Guideline 401. 5 male and 5 female rats received the test item at the single dose of 5000 mg/kg bw by oral intubation. Observations of mortality and clinical signs were carried out after 1, 2, 3, 5 and 24 hrs of dosing, and daily thereafter for 14 days; while weighing was done on days 1, 7 and 14. The surviving rats were subjected to necropsy at the end of observation period. No mortality was observed through the duration of the study. Clinical signs like sedation, dyspnoea, ruffled furs, diarrhoea, and curved body position were observed. The animals recovered within 8 days. No effect on body weight gains was seen. No substance related gross organ changes were seen during the gross pathological examination. Hence, based on the above findings, the test substance was determined to have a LD50 of >5000 mg/kg bw.