Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 26 – September 15, 1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Characteristics: powder
Storage conditions: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Acclimatization: at least 5 days before the start of the test. Animals were observed daily to ascertain their fitness for the study.
Housing: 5 animals/sex/cage in air-conditioned room.
- Temperature: 22°C ± 2
- Relative humidity: 55% ± 10
- Air changes: about 15-20/hour filtered on HEPA 99.97%
- Light: 12 hour cycle (7 a.m. – 7 p.m.)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Methocel MC, USP 350-550 mpa.s
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males + 5 females
Control animals:
yes
Details on study design:
Observation period: 14 days after administration
Observation of clinical signs and mortality: at 30 minutes, 2,4 and 6 hours on the first day after the administration and then twice a day up to termination of the observation period.

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 occorre in the treated animals of either sex. The LD50 was not calculated and it was considered higher than 2000 mg/kg.
Clinical signs:
No clinical changes were observed in the animals during the observation period.
Body weight:
Body weights of both males and females were found to be unaffected by the test article administration.
Gross pathology:
At the autopsy carried out at the end of the observation period, no appreciable macroscopic findings were evident in any treated rat.

Any other information on results incl. tables

No deaths or clinical changes occurred in the animals. At the final killing no appreciable macroscopic findings were evident in any animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test article DTZ62, when administered to rats as a single dose by oral route, is higher than 2000 mg/kg. At this dose the compound did not induce appreciable toxic signs in the rats.