Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The study was conducted according to an internal method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
Specific details on test material used for the study:
- Purity: approx. 100%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gassner (breeder)
- Weight at study initiation: mean weight: males: 230 g, females: 180 g
- Diet (e.g. ad libitum): HERILAN MRH-Haltung, Alleinfutter für die Haltung von Mäusen, Ratten und Hamstern, Heinrich EGGERSMANN KG, Rinteln

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % in water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % in 0.5 % aqueous CMC
- Amount of vehicle (if gavage): 10 ml/kg

MAXIMUM DOSE VOLUME APPLIED: males: 2.3 ml; females 1.8 ml (10 ml/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: daily (except on weekends)
- Frequency of weighing: before treatment and on days 2, 7 and 13
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
None of the animals died during the exposure period.
Clinical signs:
No abnormal observations, animals were in good general health throughout the study.
Body weight:
Day 3, mean weight (g): males: 261; females 204
Day 8, mean weight (g): males: 295; females 215
Day 14, mean weight (g): males: 324; females 230.
No abnormal body weight gain.
Gross pathology:
No abnormal observations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met