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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF strain)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Toxicology/Pathology, PH 2.635, CIBA-GEIGY Limited, Basle, Switzerland
- Weight at study initiation: 160 to 180 g
- Fasting period before study: overnight
- Housing: macrolon cages
- Diet: a standard diet of Nafag, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 10 h dark/14 h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: carboxymethyl-cellulose 2 %
Details on oral exposure:
DOSAGE PREPARATION:
FAT 36080/A was suspended with carboxymethyl-cellulose 2 %. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Fasting details:
Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period.
Doses:
6000, 7750, 9000 and 10000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, mortality check and autopsies
Statistics:
Not specified

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was recorded in animals treated at 6000 and 7750 mg/kg bw. However, 1 female at the dose of 9000 mg/kg bw as well as 2 males and 1 female at the dose of 10000 mg/kg bw were found dead at the 24 hour observation after dosing.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Sedation and ruffled fur became more accentuated as the dose was increased. The surviving animals recovered within 8 to 9 days.
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of FAT 36080/A in rats was determined to be >10000 mg/kg bw.
Executive summary:

The acute oral LD50 of FAT 36080/A was determined in a study conducted according to the methodology that is equivalent to the OECD Guideline 401. Groups of 5 males and 5 females each, were administered the test item at the doses of 6000, 7750, 9000 and 10000 mg/kg bw. Clinical signs and mortality check were recorded during an observation period of 14 days. Autopsies were performed at the end of the observation period. No mortality was recorded in animals treated at 6000 and 7750 mg/kg bw. However, 1 female at the dose of 9000 mg/kg bw as well as 2 males and 1 female at the dose of 10000 mg/kg bw were found dead at the 24 hour observation after dosing. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Sedation and ruffled fur became more accentuated as the dose was increased. The surviving animals recovered within 8 to 9 days. No substance related gross organ changes were seen. Hence, based on the above findings, the acute oral LD50 in rats was determined to be >10000 mg/kg bw.