Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
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:
- Name of test material (as cited in study report): FAT 40'400/A
- Lot/batch No.: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995
- Stability: Stable
- Stability of test article dilution: at least 2 hours

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 9 weeks, females, 11 weeks
- Weight at study initiation: males: 206 - 230 g, females: 175 - 195 g
- Fasting period before study: 12-18 hours
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batches 67/90 and 68/90 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst, available ad libitum
- Water (e.g. ad libitum): Community water from Itingen, available ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw at 2000mg/kg group, 20mL/kg bw at 5000mg/kg bw group
Doses:
2000 or 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: Mortality / Viability: Four times during test day 1, and daily during days 2-15, Body Weights: Test days 1 (pre-administration), 8 and 15, Symptoms: Each animal was examined for changes in appearance and behavior four times during day 1, and daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (general behaviour, respiration, eye, nose, motility, body posture, motor susceptibility, skin), gross pathology
Statistics:
The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0 % at 2000 mg/kg bw
0 % at 5000 mg/kg bw
Clinical signs:
2000 mg/kg: no clinical signs observed
5000 mg/kg: diarrhea (only observed at the first day of observation)
Body weight:
The body weight gain of the animals was not affected by the test article treatment throughout the entire study period.
Gross pathology:
No macroscopical findings were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the test substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 5000 mg/kg bw.
Executive summary:

In a GLP compliant oral toxicity study, performed according to OECD guideline 401, Wistar rats (5/sex/dose) were administered the test substance (2000 or 5000 mg/kg bw) by oral gavage followed by a 14-day observation period. All animals survived. Only diarrhea was observed in the highest dose group during day one of the observation period. No macroscopical changes were observed. Based on the observations, the acute oral toxicity of the test substance in rats of both sexes observed for a period of 14 days was greater than 5000 mg/kg bw.