Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-08-15 to 1991-08-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study reliable without restrictions Minor deviation from the guideline without an effect on the results: - According to the guideline, the surviving animals should be weighed and then sacrificed at the end of the test. In this study, the animals were weighed before a fasting period, which was carried out 16 h before scarification of the animales.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
, adopted 1987-02-24
Deviations:
yes
Remarks:
, see "rational for reliability"
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:
- Physical state: Powder, yellow
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-W7950 Biberach, FRG.
- Age at study initiation: Young adult animals
- Weight at study initiation: Mean weight males: 187 g ( range 185 g - 192 g); mean weight females: 192 g (range 190 - 193 g)
- Fasting period before study: the animals were given no feed at least 16 hours before administration, but water was available as libitum
- Housing: Single housing; Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG); no bedding in the cages; Sawdust in the waste trays
- Diet (ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum per day): Tap water
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE - Aqua bidest.
- Concentration in vehicle: 22.000 g/100ml
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium

MAXIMUM DOSE VOLUME APPLIED: 10. 00 ml/kg

- Rationale for the selection of the starting dose: BAsed on the physical and chemical charateristics of the test substance no pronounced acute oral toxicity was expected. Therefore a dose of 2200 mg/kg body weight has been chosen for the study.
No further information on the oral exposure was stated.
Doses:
2200 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights were determined shortly before application (Day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms was made several times on the day of administration, at least once each workday for the individual animals. A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
- Necropsy of survivors performed: Yes
Necropsy was conducted at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross pathology examination. necropsy of all animals that died before as early as possible.
No further information on the study design was stated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1 % significance level
Mortality:
No mortality occurred.
Clinical signs:
Signs of toxicity have not been noted.
Body weight:
The expected body weight gain has been observed in the course of the study.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the acute oral median lethal dose (LD 50) of the test material was found to be greater than 2200 mg/kg body weight for male and female animals.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic by the oral route.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic by the oral route.