Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% hydroxyethylcellulose (HEC) in deionized water
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 male and 3 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to the Globally Harmonized Classification System, IN 00078280 administered orally at dose levels of 2000 mg/kg in male and female rats
was considered to be a Category 5 test substance with an LD50 ∞ (unclassified).
Executive summary:

A. Title Acute Oral Toxicity Study of IN 00078280 in the Rat - Acute Toxic Class Method

B. Objective This study was designed to assess the toxicity of IN 00078280 following a single oral dose to the rat. The results of the study are believed to be of value in predicting the likely toxicity in man by the oral route.

C. Methods One group of three female Wistar rats were orally administered IN 00078280 via oral gavage at 2000 mg/kg. Due to the lack of mortality observed in the females at 2000 mg/kg, an additional group of three males was administered the test article at 2000 mg/kg. Mortality checks were made once daily. Clinical observations were recorded at approximately 0.5, 1 and 4 hours post dose (±15 minutes), and daily thereafter through Day 15. Body weights were recorded on Day 1 (fasted) and on Days 8 and 15. A gross necropsy was performed on all animals on Day 15.

D. Results No mortality was observed in any of the animals at 2000 mg/kg. No clinical signs were observed in the animals at 2000 mg/kg. All animals gained weight throughout the study. Necropsy revealed no visible lesions in any of the animals at 2000 mg/kg at terminal necropsy.

E. Conclusion According to the Globally Harmonized Classification System, IN 00078280 administered orally at dose levels of 2000 mg/kg in male and female rats was considered to be a Category 5 test substance with an LD50 ∞ (unclassified).