Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
June, 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to the prediction of toxicity delivered by the software Tox Boxes 2.9, Acute Toxicity overview indicates value with moderate and borderline reliability index
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In silico prediction.
Tox Boxes 2.9 is the in house software for the prediction of basic toxicity endpoints in chemicals. Predictions are made analyzing the chemical structure and based upon large validated databases and QSAR models, in combination with expert knowledge of organic chemistry and toxicology.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse

Administration / exposure

Route of administration:
other: intraperitoneal, intravenous, subcutaneous

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
208 mg/kg bw
Remarks on result:
other: The intraperitoneal toxicity overview indicates values with moderate reliability index by Tox Boxes 2.9 (software for the prediction).
Sex:
not specified
Dose descriptor:
LC50
Effect level:
63 mg/kg bw
Remarks on result:
other: The intravenous toxicity overview indicates values with borderline reliability index by Tox Boxes 2.9 (software for the prediction).
Sex:
not specified
Dose descriptor:
LC50
Effect level:
672 mg/kg bw
Remarks on result:
other: The subcutaneous toxicity overview indicates values with moderate reliability index by Tox Boxes 2.9 (software for the prediction).

Applicant's summary and conclusion

Conclusions:
The acute toxicity overview for intraperitoneal, intravenous and subcutaneous routes in mouse indicates values with moderate and borderline reliability index by Tox Boxes 2.9 (software for the prediction).