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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Remarks:
QSAR model
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
QSAR prediction: Accepted HESS QSAR method for chemicals properties assessment.. This method is relevant for Repeated dose oral toxicity endpoints in mammals.

Data source

Referenceopen allclose all

Reference Type:
other: QSAR model
Title:
Unnamed
Year:
2015
Reference Type:
publication
Title:
Combined repeated dose/reproductive/developmental toxicity screening study
Author:
Ministry of Health, Labour and Welfare
Year:
2004
Bibliographic source:
harmaceutical and Food Safety Bureau, Office of Chemical Safety, Japan. 2004.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: QSAR Toolbox Version 3.3.5.17
Principles of method if other than guideline:
The profiler was developed by National Institute of Technology and Evaluation (NITE) in the contract research project “Development of Hazard Assessment Techniques by using Structure-activity Method (FY2007-FY2011)” by New Energy and Industrial Technology Development
GLP compliance:
no
Remarks:
not applicable HESS QSAR method for chemicals properties assessment.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: QSAR model
Sex:
male/female

Administration / exposure

Route of administration:
other: QSAR model
Vehicle:
other: QSAR model
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
QSAR model
Duration of treatment / exposure:
QSAR model
Frequency of treatment:
QSAR model
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
other: QSAR model
No. of animals per sex per dose:
QSAR model
Control animals:
other: QSAR model
Details on study design:
The profiler contains category boundaries to be expected to induce similar toxicological effects in repeated dose oral toxicity. These category boundaries were developed based on repeated dose toxicity test data in the database of Hazard Evaluation Support System (HESS). Justification for each category (mechanistic or empirical information) is described.

Examinations

Observations and examinations performed and frequency:
This grouping method contains simple categories for Repeated dose oral toxicity. This method is relevant for Repeated dose oral toxicity endpoints in mammals.
The database include a set of 75 chemicals that have been evaluated for their repeated dose oral toxicity potential.
Other examinations:
This grouping method contains simple categories for Repeated dose oral toxicity. This method is relevant for Repeated dose oral toxicity endpoints in mammals.
The database include a set of 75 chemicals that have been evaluated for their repeated dose oral toxicity potential.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Details on results:
In the present study, NOAEL for Repeated dose oral toxicity was 385 mg/kg bw/day (No adverse effects on the highest dose tested).

Effect levels

Dose descriptor:
NOAEL
Effect level:
385 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: In the present study, NOAEL for Repeated dose oral toxicity was 385 mg/kg bw/day (No adverse effects on the highest dose tested).

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

See attached background material and QSAR study report

Applicant's summary and conclusion

Conclusions:
In the present study, NOAEL for Repeated dose oral toxicity was 385 mg/kg bw/day (No adverse effects on the highest dose tested).This grouping method contains simple categories for Repeated dose oral toxicity. This method is relevant for Repeated dose oral toxicity endpoints in mammals.
The database include a set of 75 chemicals that have been evaluated for their repeated dose oral toxicity potential.
Executive summary:

In the (Q)SAR study, NOAEL for Repeated dose oral toxicity was 385 mg/kg bw/day (No adverse effects on the highest dose tested) for S-allyl O-pentyl dithiocarbonate. This HESS QSAR grouping method contains simple categories for Repeated dose oral toxicity.This method is relevant for Repeated dose oral toxicity endpoints in mammals. The database include a set of 75 chemicals that have been evaluated for their repeated dose oral toxicity potential.