Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
2 October 2019
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:
The model is been assessed according to the OECD principles for the validation of QSAR, to generate a transparent, understandable, reproducible and verifiable result.

Data source

Reference
Reference Type:
publication
Title:
QSAR Application Toolbox Workflow
Author:
Laboratory of Mathematical Chemistry, Bourgas University “Prof. Assen Zlatarov” Bulgaria
Year:
2015
Bibliographic source:
https://echa.europa.eu/documents/10162/22838464/QSAR_Toolbox_workflow_en.pdf/

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ECHA Guidance on information requirements and chemical safety assessment - Chapter R.06: QSARs and grouping of chemicals.
Principles of method if other than guideline:
Prediction made using QSAR Toolbox v.4.3.1 Database version: 4.3.1

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl succinate
EC Number:
203-419-9
EC Name:
Dimethyl succinate
Cas Number:
106-65-0
Molecular formula:
C6H10O4
IUPAC Name:
dimethyl succinate

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
other: water, 3 % gum arabic in purified water, corn oil
Vehicle:
corn oil

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Other effects:
not examined

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not examined
Reproductive function: sperm measures:
not examined
Reproductive performance:
not examined

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
707 mg/kg bw/day (nominal)
Based on:
other: (Q)SAR
Sex:
male/female

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not examined
Gross pathological findings:
no effects observed
Histopathological findings:
not examined

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
The test material had no effect on reproductive performance.
Executive summary:

The test material had no effect on reproductive performance.