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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
April - June 2022
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH
[Please provide information for all of the points below addressing endpoint-specific elements that were not already covered by the overall category approach justification made available at the category level. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Applying the principals and operations of the OECD QSAR Toolbox, a category of substances was identified, where the member substances are sufficiently similar, in terms of selected profiles of OECD QSAR Toolbox to allow a trend analysis for the endpoint reproductive toxicity, expressed as oral NOAEL.

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL)
Only standard tasks within the OECD QSAR Toolbox were performed. No manual selection/deletion of data was done. The OECD QSAR Toolbox is an internationally recognised software program for the tasks of category building, profiling of chemicals and data gap filling.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2022
Report date:
2022

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Trend analysis of Category develped in OECD QSAR Toolbox
GLP compliance:
no

Test material

1
Chemical structure
Reference substance name:
1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
EC Number:
807-422-1
Cas Number:
66918-01-2
Molecular formula:
C40H78O5
IUPAC Name:
1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
Specific details on test material used for the study:
not applicable for in silico study

Test animals

Species:
other: see attached documents for details
Strain:
other: see attached documents for details
Details on species / strain selection:
see attached documents for details
Sex:
male/female
Details on test animals or test system and environmental conditions:
see attached documents for details

Administration / exposure

Route of administration:
other: see attached documents for details
Details on exposure:
see attached documents for details
Details on mating procedure:
see attached documents for details
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
see attached documents for details
Duration of treatment / exposure:
see attached documents for details
Frequency of treatment:
see attached documents for details
Details on study schedule:
see attached documents for details
No. of animals per sex per dose:
see attached documents for details
Control animals:
other:
Details on study design:
see attached documents for details
Positive control:
see attached documents for details

Examinations

Parental animals: Observations and examinations:
see attached documents for details
Oestrous cyclicity (parental animals):
see attached documents for details
Sperm parameters (parental animals):
see attached documents for details
Litter observations:
see attached documents for details
Postmortem examinations (parental animals):
see attached documents for details
Postmortem examinations (offspring):
see attached documents for details
Statistics:
see attached documents for details
Reproductive indices:
see attached documents for details
Offspring viability indices:
see attached documents for details

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
858
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other:
Remarks on result:
other: see attached documents for details

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
858
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other:
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
A NOAEL for reproductive toxicity was estimated using OECD QSAR Toolbox. A category containing 17 chemicals was identified and the NOAEL was calculated by the principals of trend analysis.
A NOAEL of 858 mg/kg bw/day was identified.