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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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See Chapter 13 for detailed read across justification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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 36002/G TE
Lot: DX201409-01
Appearance: Dark blue powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Test substance: FAT 40284/A
Batch No.: EN 47342.52
Contents of active ingredients : 29.3 %
Physical properties: powder; dispersible in water; pH: 9.0 (lg/1 water)
Storage conditions: room temperature
Validity: November 1991
Safety precautions: gloves and face masks
Test material received: December 12, 1986

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF) hybrids of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
Experimental Animals
Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial Body Weight Range: 180 to 231 g
Initial Age: 7-8 weeks
Individual Identification: by colour code using picric acid

Husbandry:
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).
The animal room was air conditioned: temperature 22+_3° C, relative humidity 55+_15%, 12 hours light/day, approximately 15 air changes/h.

Diet:
Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum

Acclimatisation:
at least 5 days before administration

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
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: clinicals signs-daily, mortality check- daily twice, body weights weekly
- Necropsy of survivors performed: yes
Statistics:
From the body weights, the group means and their standard deviations were calculated.

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 was observed throughout the observation period.
Clinical signs:
Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration.
The animals recovered within 12 days.
Body weight:
No adverse effects on body weight changes was observed.
Gross pathology:
No gross abnormalities were found.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
FAT 40284/A was determined to have a LD50 of >5000 mg/kg bw.
Executive summary:

The acute oral toxicity of the read across substance was evaluated in a study conducted according to OECD Guideline 401. A single group consisting 5 males and 5 females was administered a dose of 5000 mg/kg bw once and observed over a period of 14 days for clinical signs, mortality an body weight changes. The surviving animals were sacrificed and necropsies were conducted at the end of the observation period. Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. Additionally, diarrhea was found three and five hours after the administration. The animals recovered within 12 days. No mortality and no adverse effect on body weights were seen. No gross abnormalities were found during the necropsy. Hence, LD50 for FAT 40284/A was determined to be > 5000 mg/kg bw.