Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1994-11-16 to 1994-11-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study followed the procedures indicated by internationally accepted guidelines and recommendations as Commission Regulation (EC) No 440/2008 (B.1: Acute Toxicity (Oral)).
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
directive 92/69/EEC
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 February 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: males: mean 267 g; females: mean 181 g
- Fasting period before study: overnight prior to dosing
- Housing: polycarbonate cages, 5 animals per sex per cage
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days, under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50 % relative humidity
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
NA
Doses:
single dose: 2000 mg/kg
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: twice daily; clinical signs: once daily; body weights: day 1, 8, and 15;
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Preliminary study:
NA
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
NA
Other findings:
Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight for both sexes.
Executive summary:

In an acute oral toxicity study, groups of fasted, approx. 10 weeks old Wistar rats (5/sex) were given a single oral dose of the test item in water at a dose of 2000 mg/kg bw and observed for 14 days.

No animals died during the study. No clinical signs were observed during the study period. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

The Oral LD50 was determined to be > 2000 mg/kg bw.