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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding RCC Laboratories India Private Limited
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 177.1-197.5 g
- Fasting period before study:
- Housing: In groups of three in Polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1-22.1
- Humidity (%): 57-66
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
applied undiluted in 4 steps (2 per dose: 2x 300 mg/kg, 2 x 2000 mg/kg)
Doses:
300, 2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
All treated animals appeared normal.
Body weight:
No effect on body weight.
Gross pathology:
No abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on the results, the median lethal dose of the test item after single oral administration to female rats, observed over a period of 14 days is: LD50 >2000 mg/kg bw