Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12/03/2012-03/05/2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted at a GLP accredited laboratory to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
- Fasting period before study: overnight

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
14 day were monitored
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 female
Details on study design:
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of SDIPB at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Results and discussion

Preliminary study:
Using available information on the toxicity of the test item, 2000mg/kg was chosen as the starting dose. One rat was dosed once only by gavage. In the absence of toxicity at 2000 mg/kg dose (1.74 ml/kg), a total of five animals were treated at a dose level of 2000 mg/kg in the stduy.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight.
Other findings:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) of the SDIPB in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw.
Executive summary:

To cover the endpoint acute oral toxicity of substance SDIPB, fixed dose method was applied to female Wistar strain rats according to OECD Guideline 420, and EU method B.1 bis. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of SDIPB at a dose level of 2000 mg/kg bw. The acute oral median lethal dose (LD50) of the SDIPB in the female Wistar strain rat was estimated to be > 2000 mg/kg bw.

SDIPB should not be classified as acute oral toxicity according to CLP regulation and DSD criteria.