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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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
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: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 189.2 - 209.6 g; females: 173.6 - 185.2 g
- Housing:Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum):Pelleted standard Kliba 343, Batch no. 65/95 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to application). Results of analyses for contaminants are included in the report.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period: One week under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21-23
- Humidity (%):42-79
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bi-distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:10 ml/kg
Doses:
2000 mg/kg
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: yes
- Other examinations performed: clinical signs, body weight, mortality
Statistics:
The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths as a result of treatment with the test article.
Clinical signs:
Diarrhoea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period.
Body weight:
The body weight of the animals was within the normal range for rats of this strain and age.
Gross pathology:
No organ abnormalities were observed at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
LD50 in rats of both sexes is found to be greater than 2000 mg/kg body weight
Executive summary:

The test article FAT 20035/D was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight.

There were no deaths as a result of treatment with the test article.

Diarrhea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period.

The body weight of the animals was within the normal range for rats of this strain and age.

No organ abnormalities were observed at necropsy.

The mean lethal dose of FAT 20035/D after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, Hence, the LD50 is greater than 2000 mg/kg.