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:
From 09 November, 1978 to 6 December, 1978
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:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Groups of 5 male and 5 female rats each were administered test dose of 4000, 5000, 6000 and 7000 mg/kg bw respectively. Mortality and clinical signs were observed for each group for a period of 14 days.
GLP compliance:
no
Remarks:
Study predates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch No.: EN 80524/76
Physical appearance: Solid
Test material received: October 17, 1978

Test animals

Species:
rat
Strain:
other: Tif. RAI rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Inbred rats (male and females) : CIBA-GEIGY Limited, Basel, Switzerland.
- Strain : Tif: RAIf (SPF)
- Age at study initiation: 7 to 8 weeks.
- Weight at study initiation: Average weight of 205 gm.
- Housing : Macrolon cages (Type 3)
- Diet : Rats received ad libitum rat food - NAFAG, Gossau SG.
- Water : ad libitum.
- Acclimation period: 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature : 22 +/- 1 °C
- Humidity : 55 +/- 5 %
- Photoperiod : 10 hours light cycle day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
Test material and formulation:
FAT 11127/B was suspended in PEG 400. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. Animals fasted overnight were treated by oral intubation.
Volume fed: 20 ml/kg bw.
Doses:
4000, 5000, 6000 and 7000 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: 1, 2, 4, 6 and 24 hours after dosing on Day 1 and daily thereafter till Day 14
- Weighing: Day 1, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 000 mg/kg bw
Based on:
test mat.
Mortality:
2 female rats of 5000 mg/kg group were found dead within 24 hours of dosing. No mortality was observed with any other groups.
Clinical signs:
Sedation and diarrhoea were observed in all test groups in first 24 hours. Dyspnoea persisted till Day 8 in all test groups. Exophthalmos was seen till Day 6. Ruffled fur was observed in till day 8, while curved body position lasted in all test groups till Day 8.
Body weight:
There was a gradual increase in body weights. No abnormality detected in body weights.
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of FAT 11127/B in rats of both sexes observed over a period of 14 days is greater than 7000 mg/kg bw.
Executive summary:

FAT 11127/B was tested for acute oral toxicity potential (LD50) using methodology similar to OECD Guideline 401. 5 rats per sex per group were tested with doses of 4000, 5000, 6000 and 7000 mg/kg bw. The test substance was administered using oral gavage. Animals were observed for 14 days for mortality, clinical signs and changes in bodyweights. They were submitted at random to a necropsy whenever they died, survivors at the end of the observation period.

2 animals were found dead at the dose of 5000 mg/kg bw within 24 hours of observation. No other mortality was seen at any of the tested doses. Clinical signs observed included sedation, diarrhoea, dyspnoea, exopthalmos, ruffled fur and curved body position. The surviving animals recovered within 8 days. No significant changes in body weights was observed. No gross pathological changes were observed. Hence, based on the above findings, the oral LD50 for FAT 11127/B was determined to be >7000 mg/kg bw.