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Diss Factsheets
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EC number: 249-047-0 | CAS number: 28473-19-0
- 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:
- multi-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study on a read-across compound, reported in the secondary literature (limited reporting). Only one (relatively low) dose level tested (about 10 mg/kg bw/day); screening reproduction/developmental screening limit tests use at least 1000 mg/kg bw/day.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 952
- Report date:
- 1952
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Four-generation study, in which rats were treated via the diet with DOS at 200 mg/kg. Only one (relatively low) dose level tested (about 10 mg/kg bw/day). Abnormalities during parturition and nursing, and effects on growth, were assessed in the various generations.
- GLP compliance:
- no
- Remarks:
- predates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Dioctyl sebacate
- EC Number:
- 219-411-3
- EC Name:
- Dioctyl sebacate
- Cas Number:
- 2432-87-3
- Molecular formula:
- C26H50O4
- IUPAC Name:
- dioctyl sebacate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): dioctyl sebacate
- Molecular formula (if other than submission substance): C26-H50-O4
- Molecular weight (if other than submission substance): 426.677
- Smiles notation (if other than submission substance): C(=O)(OCCCCCCCC)CCCCCCCCC(=O)OCCCCCCCC
- InChl (if other than submission substance): InChI=1S/C26H50O4/c1-3-5-7-9-15-19-23-29-25(27)21-17-13-11-12-14-18-22-26(28)30-24-20-16-10-8-6-4-2/h3-24H2,1-2H3
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- - M/F ratio per cage: no data in citing sources
- Length of cohabitation: no data in citing sources
- Proof of pregnancy: no data in citing sources
- Further matings after two unsuccessful attempts: no data in citing sources
- After successful mating each pregnant female was caged (how): no data in citing sources
- Any other deviations from standard protocol: no data in citing sources - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 generations
- Frequency of treatment:
- Presumably daily (given in the diet)
- Details on study schedule:
- No data in citing sources
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 mg/kg diet
Basis:
nominal in diet
equivalent to about 10 mg/kg bw/day for adult rats, and 20 mg/kg bw/day for young rats
- No. of animals per sex per dose:
- No data in citing sources
- Control animals:
- yes, plain diet
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects seen over the course of the study
- Remarks on result:
- other: Generation: all generations (migrated information)
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed at dose.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Secondary sources report on a pre-GLP four-generation study on DOS, a structurally-related read-across compound for DIDS. Reproduction, suckling and growth were evidently normal in rats of the various generaitons recieving about 10 mg/kg bw/day from the diet (the study NOAEL).
- Executive summary:
A pre-GLP four-generation study has been conducted on DOS, a structurally-related read-across compound for DIDS, and is reported in the secondary literature.
Rats were treated with a single (relatively low) dose level of 200 mg/kg diet (about 10 mg/kg bw/day) over four generations [no further details in citing sources; screening developmental/reproductive limit tests use a dose level of at least 1000 mg/kg bw/day].
Reproduction was considered normal, and no abnormalities were found during parturition or nursing. Growth was evidently normal in each generation. The no-observed-adverse-effect level for fertility effects can therefore be considered about 10 mg/kg bw/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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