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EC number: 271-090-9 | CAS number: 68515-48-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.01.1996-13.02. 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP compliant study undertaken to a standard considered to be equivalent to international test guidelines for a chromosome aberration study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
- Reference Type:
- publication
- Title:
- Di(isononyl) phthalate (DINP) and di(isodecyl) phthalate (DIDP) are not mutagenic.
- Author:
- McKee RH, Przygoda RT, Chirdon MA, Engelhardt G, Stanley M.
- Year:
- 2 000
- Bibliographic source:
- J Appl Toxicol. 2000 Nov-Dec;20(6):491-7.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- EC Number:
- 271-090-9
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- Cas Number:
- 68515-48-0
- Molecular formula:
- C26 H42 O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- Reference substance name:
- DINP
- IUPAC Name:
- DINP
- Details on test material:
- - Name of test material (as cited in study report): Di-isononyl phthalate
- Substance type: Technical material
- Physical state: Colourless liquid
-Stability under test conditions: Room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- WBL clone, supplied by Merck Research Laboratories, West Point , Pennsylvania, USA. Received 5 June 1992
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat
- Test concentrations with justification for top dose:
- 0 (vehicle control), 5, 10, 20, 40, 80 and 160 micrograms/ml. The treatment groups and test concentrations are tabulated in the 'overall remarks and attachments' window below.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Solubility
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- None Migrated to IUCLID6: and, N-Methyl-N-Nitro-N-Nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: None
- Exposure duration: 3 or 20 hours
- Expression time (cells in growth medium): 20 or 44 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 20 or 44 hours
SPINDLE INHIBITOR (cytogenetic assays): Yes (Colcemid)
STAIN (for cytogenetic assays): Yes (5% Giemsa)
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 200 per per treatment group
DETERMINATION OF CYTOTOXICITY:
- Method: mitotic index; number of mitotic cells per 1000 total cell count
OTHER EXAMINATIONS:
- Determination of polyploidy: Included in aberrration totals. If marked increases had been noted the frequency would have been calculated based on 500 metaphases in the particular flask
- Determination of endoreplication: Not included in aberration totals. If marked increase had been noted the frequency would have been calculated based on 500 metaphases in the particular flask.
- Evaluation criteria:
- See 'overall remarks and attachments' window below
- Statistics:
- See 'overall remarks and attachments' window below
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data (unlikely as substance has low vapor pressure and a Log P o/w relatively high)
- Water solubility: Doses were significantly higher than the estimated water solubility of DINP (2 µg/ml).
- Precipitation: precipitation was thought to have occured on some occasions at 40, 80 or 160 µg/ml
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: YES
A toxicity pre-test was performed to determine appropriate doses for the main study.
COMPARISON WITH HISTORICAL CONTROL DATA: No quantitative data reported.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
A tabulated summary of results is presented in the 'overall remarks and attachments' window below.
No statistically significant differences were observed between the test and vehicle control groups in the percentage of aberrant cells following treatment with the test substance at 40, 80 or 160 µg/l, either with or without metabolic activation, for the initial or repeat asssays.
Although there was a statistically significant trend of the series without metabolic activation for the 20-hour harvest in the repeat asssay, the response at the high dose (160 µg/ml) was not extreme and is within the normal range of the vehicle control. It was not supported by an observable dose response, and was not supported by other results at other harvests. Examination of the replicates showed that one flask at 160 µg/ml, had 6 aberrant cells out of 100 while the other flask at the same dose had only 2 aberrant cells out of 100. It appeared that the one flask (6/100) was anomalous and not representative of the other data. Based on this data analysis, there was no statistically significant relationship between dose and the number of aberrant cells.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance did not induce chromosomal aberrations in chinese hamster ovary cells - Executive summary:
Chinese hamster ovary (CHO) cells were exposed to di-isononyl phthalate (DINP) in acetone at concentrations of 5,10, 20, 40, 80 or 100 µg/ml media, for 3 hours (with and without metabolic activation) in an initial assay, or 3 hours (with metabolic activation) and 20 hours (without metabolic activation) in a repeat assay, and harvested after 20 or 44 hours incubation, respectively. DINP did not induce chromosomal aberrations in the cultured CHO cells at any of the evaluted dose levels (40, 80 and 160 µg/ml) with and without metabolic activation.
The study was considered acceptable for classification, and satisfied the requirements for mammalian cell chromosomal aberration studies.
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