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Diss Factsheets
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EC number: 807-422-1 | CAS number: 66918-01-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
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:
- 2 022
- 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
- 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
1
- 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.
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