Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August - October 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 423) and in compliance with GLP.

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
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
300mg/kg and 2000mg/kg
No. of animals per sex per dose:
300mg/kg : 3 male and 3 female; starting dose
2000mg/kg : 3 male and 3 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 - <= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in any of the animals at 300 or 2000mg/kg.
Clinical signs:
No clinical signs were observed in the animals at 300 or 2000mg/kg.
Body weight:
All animals at 300 and 2000 mg/kg gained weight throughout the study.
Gross pathology:
No visible lesions were observed in any of the animals at 300 or 2000 mg/kg at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to the GHS system, IN00078283 adminstered orally at dose levels of 300 and 2000 mg/kg body weight in male and female rats was considered to be a Category 5 test substance with an LD50 greater than 2000-5000 mg/kg.
Executive summary:

No mortality was observed in animals at 300 or 2000 mg/kg. No clinical signs were observed in the animals at 300 or 2000 mg/kg. All animals at 300 and 2000 mg/kg gained weight throughout the study. No visible lesions in any of the animals at 300 or 2000 mg/kg at terminal necropsy.