Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1974
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:
1974
Report Date:
1974

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:
Toxicity of FAT 40062/A in rat of both sexes observed over a period of 14 days by treating with 3 dose concentrations.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals

Species:
rat
Strain:
other: 30 Tif. RAI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Huntsman/ CIBA- Geigy Limited
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g
- Fasting period before study: 1 night before starting the treatment
- Housing: housed in Macrolon cages (Type 3)
- Diet: NAFAG, Gossau SG, rat food ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): approximately 50

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 %

Doses:
4640, 6000, 7750 mg/kg (No higher doses were possible)

No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 h, 24 h, 48 h, 7 days and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No substance related gross organ changes were seen.

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 750 mg/kg bw
Based on:
test mat.
Mortality:
One female rat died after 24 h at 7750 mg/Kg concentration.
Clinical signs:
Within 2 h after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 8 days.
Body weight:
Not provided
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 median lethal dose (LD50) of FAT 40062/A in rats of both sexes was greater than 7750 mg/kg.
Executive summary:

This study was conducted prior to GLP and test guidelines and very limited information is available for interpretation of results. Toxicity of FAT 40062/A in rat of both sexes observed over a period of 14 days by treating with 3 dose concentrations as 4640, 6000, 7750 mg/kg. The compound was tested on 30 Tif. RAI rats (15 males/ 15 females), bred under SPF conditions by in-house breeding unit. At the initiation of the treatment the rats were 6 to 7 weeks old and weighed 160 to 130 g. The rats were starved during one night before starting the treatment. The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22 +/- 1 °C and a relative humidity of approximately 50 %. They received water and food (NAFAG, Gossau SG, rat food) ad libitum. FAT 40062/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 30 % with polyethylene glycol (PEG 400) and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra- Turrax and during treatment it was kept stable with a magnetic stirrer. Within 2 h after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. One female rat died after 24 h at 7750 mg/Kg concentration. The surviving animals had recovered within 8 days. They were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. The acute oral LD50 of FAT 40062/A in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg.