Registration Dossier

Administrative data

Description of key information

LD50 value for FAT 46014 upon oral administration was found to be greater than 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation:7-8 weeks
- Weight at study initiation:179-215 g
- Housing:The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22+3
- Humidity (%):55+15
- Air changes (per hr):approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light):12 hours light/day

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceutical Division, Ciba-Geigy Ltd.).
Details on oral exposure:
- Amount of vehicle (if gavage): 20 ml/kg
The animals were allocated to the different dose groups by random selection.
Prior to dosing, the animals were fasted overnight.
Doses:
5000 mg/kg bw.
No. of animals per sex per dose:
5 males/5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No
- Other examinations performed: mortality, symptoms, autopsy, body weight
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)
Preliminary study:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, a transient diarrhea and tremor was observed.
The surviving animals recovered within 10 days.
Body weight:
None
Gross pathology:
No gross lesions were found at necropsy.
Other findings:
None

None

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of FAT 46014/F in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg.
Executive summary:

Upon an acute oral administration and 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for FAT 46014/F.

LD50 in male rats: >5000 mg/kg bw

LD50 in female rats: >5000 mg/kg bw

LD50 in rats of both sexes : >5000 mg/kg bw

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A key study was conducted to determine the acute oral toxicity of FAT 46014/F in Tif. RAI rats. Test material was suspended in 0.5% carboxymethyl cellulose and 0.1% polysorbate 80, and was administered orally at dose of 5000 mg/kg. Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, a transient diarrhea and tremor was observed. Autopsy revealed, no substance related gross organ changes after observation period.

In conclusion, the acute oral LD50 of FAT 46014/F in rats of both sexes observed over a period of 14 days is >5000 mg/kg. The compound therefore is non-toxic to the rat by the oral route of administration.

In several other supporting studies LD 50 values of > 10000, >15000 and > 8000 mg/kg were recorded.

The above values shows that FAT 46014 is non-toxic via oral route of administration.

 

 

 

 


Justification for selection of acute toxicity – oral endpoint
Basic data given, acceptable for assessment

Justification for classification or non-classification

LD50 value for FAT 46014/F upon oral administration was found to be greater than 5000 mg/kg bw.

This value shows that FAT 46014 is non-toxic via oral route of administration.