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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
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EC number: 939-783-7 | CAS number: -
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (only single plating, dissimilar positive control substances), read-across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- ; only single plating, dissimilar positive control substances
- Principles of method if other than guideline:
- Pre-guideline study; but the method used is similar to OECD test guideline 471
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diisotridecyl adipate
- EC Number:
- 247-660-8
- EC Name:
- Diisotridecyl adipate
- Cas Number:
- 26401-35-4
- IUPAC Name:
- bis(11-methyldodecyl) adipate
- Details on test material:
- - Name of test material (as cited in study report): MCTR-25-78
- Physical state: slightly viscous yellowish liquid
- no further information on test substance
Constituent 1
Method
- Target gene:
- his¯ (S. thyphimurium)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from livers of Aroclor 1254 induced male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- 0.01, 0.1, 1.0, 5.0, and 10.0 µL/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 50 µL solvent/plate
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9-mix : ethylmethansulfonate (TA1535, TA100, D4 ), QM (TA1537), nitrofluoren (TA98, TA1538); with S9-mix: anthracene (TA1535, TA1537, TA1538, TA98, TA100, D4)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: S. thyphimurium 48 h at 37°C ; S. cerevisiae 3 - 5 days at 30°C (nonactivation) or at 37°C (activation)
- Expression time (cells in growth medium): 48 h or 3-5 days
NUMBER OF REPLICATIONS: single plating
DETERMINATION OF CYTOTOXICITY
- Method: no data - Evaluation criteria:
- Strains TA1535, TA1537, and TA 1538
If the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
Strains TA98, TA100, and D4
If the solvent control value is within the normal range a chemical that produces a positive dose response over three concentrations with the highest increase equal to twice the solvent control value for TA100 and 2-3 times the solvent control value for strains TA98 and D4 is considered to be mutagenic. For these strains, the dose-response increase should start at approximately the solvent control value.
Reproducibility
If a chemical produces a response in a single test that cannot be reproduced in one or more additional runs, the initial positive test data lose significance.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ; at the highest doses some cytotoxicity was observed
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ; at the highest doses some cytotoxicity was observed
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
For detailed results, see Attached background material.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Diisotridecyl adipate was not mutagenic as it did not increase the number of revertants in five strains of Salmonella typhimurium or in Saccharomyces cerevisiae strain D4 with or without metabolic activation in an Ames test performed similar to OECD TG 471. - Executive summary:
In a gene mutation assay according to Ames (1975), strains of Salmonella typhimurium (strains TA 98, TA 100, TA 1535, TA 1537, TA 1538) and Saccharomyces cerevisiae (strain D4) were exposed to diisotridecyl adipate at concentrations of 0.01, 0.1, 1.0, 5.0, and 10 µL/plate in the presence and absence of mammalian metabolic activation. Exposure was in agar (plate incorporation method) and only single plates were used per test concentration.
Diisotridecyl adipate was tested up to the limit concentration of 10 µL/plate, which exhibited slight toxicity. The positive controls induced the appropriate responses in the corresponding strains. Diisotridecyl adipate did not increase the number of revertants in the test strains used. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable with restrictions due to some deviations from OECD test guideline 471 (only single plating, dissimilar positive control substances).
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