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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
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 material form:
solid: particulate/powder
Details on test material:
Identity FAT 65004/F TE
Batch 15060201 (China)
Purity determined in this study
Appearance
Smell
yellowish powder, solid at 20°C
neutral
pH-Value pH-value of a soln. of 2% (w/w) = 6.90
Expiration date August 25th, 2020
Storage to be stored at room-temperature
Specific details on test material used for the study:
None

Test animals

Species:
rat
Strain:
other: TIf:RAI
Sex:
male/female
Details on test animals and environmental conditions:
The experiments were performed on healthy, young, random-bred rats of the Tif RAI strain. Their mean initial body weight was between 91 and 108 g. The animals had previously been acclimatized in our laboratories for at least 5 days to a constant room temperature of 22±1 °C, a relative humidity of 55±5% and 14 hours light/day. They were housed in groups of 5 in macrolon cages (Size 3). The animals were fed a standard diet of Nafag ad libitum and had free access of drinking water.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
2%
Details on oral exposure:
Tgroups of 5 male and 5 female rats, after having been fasted overnight, were given various single doses of the compound, suspended in water by gavage.
Doses:
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Symptoms and mortality after administration were recorded during an observation period of 8 days.
Statistics:
Not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No symptoms were recorded.
Body weight:
No effect on body weight gain was seen.
Gross pathology:
Not specified

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The athe acute oral median lethal dose (LD50) of compound FAT 65004/B to rats is greater than 15000 mg/kg body weight.
Executive summary:

The acute oral toxicity potential of the test substance was evaluated in a study conducted with Tif:RAI strain rats. Groups of 5 male and 5 female rats, after having been fasted overnight, were given various single doses of the compound, suspended in water by gavage. The doses administered were 1000, 3000, 10000 and 15000 mg/kg bw. No symptoms were recorded and no deaths occurred. Hence, it was concluded that the acute oral median lethal dose (LD50) of compound FAT 65004/B to rats is greater than 15000 mg/kg body weight.