Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from N0V. 14 to DEC.19, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance test with GLP compliance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: Directive 92/69/EEC, B.l. "Acute Toxicity-Oral", July 31, 1992.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Code number: FAT45'176/A
Batch No.: WP2/96
Purity: ca. 60 %
Appearance: orange-brown solid powder
Storage: room temperature
Expiration date: 11/2004

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Test System: Rat, HanIbm:WIST (SPF)
Number of animals per group: 5 males and 5 females
Age when treated: males: 8 weeks, females: 10 weeks
Body weight range when treated: males: 197.1 - 218.5 g, females: 174.8 - 186.3 g
Acclimatization: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Conditions:
Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with target ranges for temperature of 22 ± 3 degrees centigrade, and for relative humidity between 40-70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bi-distilled water
Details on oral exposure:
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 17 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
Doses:
2000 mg/kg body weight (10 mL/kg body weight)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The test item was administration to a group of 5 male and 5 female rats by oral gavage, at the single dose of 2000 mg/kg body weight. The application volume was 10 mL/kg body weight. The animals were examined and mortality, viability and clinical signs were recorded. All surviving animals were necropsied and examined macroscopically after the end of the observation period.
Statistics:
The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the range of physiological variability known for rats of this strain and age, except one female animal (no. 8) showed a slight loss of body weight during the second observation period.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (rat, oral) of the test substance is greater than 2000 mg/kg body weight.
Executive summary:

A group of five male and five female HanIbm:WIST (SPF) rats was treated with FAT 45'176/A at 2000 mg/kg body weight by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg body weight. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age, except one female animal (no. 8) showed a slight loss of body weight during the second observation period. No macroscopic findings were observed at necropsy.

The LD50(rat, oral) is greater than 2000 mg/kg body weight. And the test substance is not be classified according to the CLP regulation (Regulation EC No. 1272/2008).