Registration Dossier

Diss Factsheets

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
1985
Report date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): FAT 40181/B
- Batch No.: UO-Vers: 1131/85
- Expiration date: January 1, 1995
- Stability of test article: Stable
- Stability of test article dilution: stable for at least 2 hours

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, / Switzerland
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: Males: 216 - 246g, Females: 185-192g
- Fasting period before study: 12-18 hours
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, Switzerland).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch 22/85 rat maintenance diet ("Kliba", Klingentalmuehle AG, Switzerland) available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: One week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
4% in distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20mL/kg bw
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: 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 position, motor susceptibility, skin), gross pathology
Statistics:
The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without the 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%
Clinical signs:
other: Sedation, dyspnea, curved body position, ruffled fur. All rats recovered within 2 observation days.
Gross pathology:
No macroscopic organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the observations the toxicity of the test substance 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 (5000 mg/kg bw) by oral gavage followed by a 14-day observation period. Mortality did not occur. Sedation, dyspnea, curved body position, ruffled fur was observed, but all rats recovered within 2 observation days. No macroscopic organ changes were observed. Based on these 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.

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