Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Stability in vehicle: verified in an analytical test conducted under GLP

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: mean weight 216 g (for males) and 187 g (for females)
- Fasting period before study: 16-17 h
- Housing: in goups of 3 animals
- Diet and Water: ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Application volume: 10 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: several times on the day of administration, and at least once daily during the observation period.
- Frequency of weighing: directly before administration, after one week (only females) and at the end of the observation period or after death.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed after the application or during the 15-days post-application period.
Clinical signs:
No signs of intoxication occured during the observation time at all animals.
Body weight:
Body weight development of male and female rats was not affected.
Gross pathology:
The animals sacrificed at the end of study showed no noticeable gross pathological findings.
Other findings:
None

Applicant's summary and conclusion

Executive summary:

An oral toxicity study (OECD TG 423) with a starting dose of 2000 mg/kg bw was performed with 3 male and 3 female rats. No mortality, no clinical signs and no gross pathological findings were observed after application of the test substance in the 15-days observation period. Therefore, the LD50 was estimated to be > 2000 mg/kg bw.