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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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
Report Date:
1987

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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40'224/C
- Description: powder
- Lot/batch No.: Op. 1/86; Vers. 10/86
- Expiration date of the lot/batch: Oktober 1991
- Stability of test article dilution: stable for at least 2 hours

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: Males: 193 - 218 g; Females: 168 - 178 g
- Fasting period before study: 12 to 18 hours (access to water was not interrupted), food was again presented approximately one hour after dosing.
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, Switzerland). The cages were cleaned twice weekly during the test period.
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch 57/86 rat maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland)
available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: At least 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:
CMC (carboxymethyl cellulose)
Remarks:
4% in distilled water
Details on oral exposure:
Application volume / kg body weight: 20 mL at 5000 mg/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Mortality/viability were checked four times during test day 1, and daily during days 2-15
- Body weights were measured on test days 1 (pre-administration), 8 and 15
- All animals were necropsied.
- Each animal was examined for changes in appearance and behavior four times during day 1, and daily during days 2-15. All abnormalities were recorded. The animals were checked for the following symptoms: General behavior, Respiration, Eye, Nose, Motility, Body posture, Motor susceptibility, Skin, Loss of weight.
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:
No mortality was observed.
Clinical signs:
Sedation, dyspnea, ruffled fur.
All rats had recoverd after 2 observation days.
Body weight:
All animals showed normal body weight gain.
Gross pathology:
The following macroscopic organ changes were observed:
male No. 2: lung: several red foci, diameter 1mm.
male No. 5: lung: partly red foci, diameter 1mm.
males No. 1,3,4: no pathologic changes.
females No. 6-10 no pathologic changes.

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 FAT 40'224/C in rats of both sexes, observed over a period of 14 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) were administered the test substance (5000 mg/kg bw) by oral gavage followed by a 14-day observation period. Mortality was not observed. Symptoms observed were sedation, dyspnea and ruffled fur. All rats had recovered after 2 observation days. At necropsy 1 male showed several red foci in the lung (1 mm) and 1 male showed partly red foci in the lung (1mm). The acute oral toxicity of the test substance in rats of both sexes, observed over a period of 14 days, was estimated to be: greater than 5000 mg/kg bw.