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EC number: 240-106-6 | CAS number: 15968-01-1
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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: see 'Remark'
- Remarks:
- The substance CAS 15968-01-1 (disodium phthalate) is the sodium salt of the phthalic acid CAS 88-99-3. The main assumption is that sodium is not significant in respect of all the properties under consideration. In dilute aqueous conditions of defined pH a salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. Therefore, the results obtained with the substance CAS 88-99-3 can be used for the read-across approach.
Data source
Reference
- Reference Type:
- other: read-across
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
- Principles of method if other than guideline:
- Read-across approach from data on an analogue.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Phthalic acid
- EC Number:
- 201-873-2
- EC Name:
- Phthalic acid
- Cas Number:
- 88-99-3
- IUPAC Name:
- phthalic acid
- Details on test material:
- - Molecular formula (if other than submission substance): C8H6O4
- Molecular weight (if other than submission substance): 166.1308
- Smiles notation (if other than submission substance): OC(=O)c1ccccc1C(=O)O
- InChl (if other than submission substance): InChI=1/C8H6O4/c9-7(10)5-3-1-2-4-6(5)8(11)12/h1-4H,(H,9,10)(H,11,12)
- Structural formula attached as image file (if other than submission substance): see Fig.
Constituent 1
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The substance CAS 15968-01-1 (disodium phthalate) is the sodium salt of the phthalic acid CAS 88-99-3. The main assumption is that sodium is not significant in respect of all the properties under consideration. Therefore, the results obtained with the substance CAS 88-99-3 can be used for the read-across approach.
As indicated in the European Chemical Agency Practical Guide 6 “How to report read –across and categories”, the structural grouping was realized using “OECD QSAR APPLICATION TOOL BOX” (see attachment).
Table 1: Data Matrix, Analogue Approach
CAS Number
|
88-99-3
|
15968-01-1
|
|
CHEMICAL NAME
|
Analogue Phthalic acid
|
Target chemical Disodium phthalate |
|
PHYSICO-CHEMICAL DATA |
|||
Melting Point |
Experimental results: 230 ºC |
Experimental results: No evidence of melting point below 400 ºC. Decompositionin the range of 450 to 500 °C.
|
|
Boiling Point |
Experimental results: Decomposes
|
No determination of boiling point is required since there was no evidence of melting below 400 ºC.
|
|
Density |
Experimental results: 1.593 g/cm3 at 15 ºC |
Experimental results: 1.67 at 20.8 ºC
|
|
Vapour Pressure |
Experimental results: 8.48 x 10-5 Pa at 25 ºC |
Experimental results: < 3.9 x 10 -5 Pa at 25 ºC
|
|
Partition Coefficient (log Kow) |
Experimental results: 0.73
|
Experimental results: -2.34 at 20.1 ºC (pH 5.5)
|
|
Water solubility
|
Experimental results: 6250-7010 mg/L at 25 ºC
|
Experimental results: In the range of 45.8 to 47.9% w/w at 20 ºC.
|
|
ENVIRONMENTAL FATE and PATHWAY |
|||
Aerobic Biodegradation
|
Estimated data: Readily biodegradable (BIOWIN v4.10)
|
Estimated data: Readily biodegradable (BIOWIN v4.10)
|
|
Anaerobic Biodegradation |
No data |
No data
|
|
ENVIRONMENTAL TOXICITY |
|||
Acute Toxicity to Fish |
No data
|
No data
|
|
Acute Toxicity to Aquatic Invertebrates
|
No data |
No data |
|
Toxicity to Aquatic Plants
|
No data |
No data |
|
MAMMALIAN TOXICITY |
|||
Acute Oral |
Experimental results: LD50 = 2530 mg/kg (mouse)
|
Read-across: LD50 = 3200 mg/kg (mouse)
|
|
Acute Inhalation
|
No data |
No data |
|
Acute Dermal |
No data |
Experimental results: LD50 > 2000 mg/kg
|
|
Skin irritation / Eye irritation |
No data |
Experimental results: Not a skin irritant. Not an eye irritant.
|
|
Skin sensitisation |
No data |
Experimental results: Non-sensitising.
|
|
Repeated Dose |
No data
|
No data
|
|
Genetic Toxicity in vitro
|
Gene mutation in bacteria
|
Experimental results: Negative |
Read-across: Negative |
Chromosomal aberration
|
Experimental results: Negative |
Experimental results: Negative |
|
Mammalian gene mutation
|
No data |
Experimental results: Negative |
|
Genetic Toxicity in vivo
|
Experimental results: Negative |
Read-across: Negative |
|
Carcinogenicity
|
No data
|
No data |
|
Reproductive Toxicity: developmental toxicity |
Developmental toxicity: No evidence of developmental toxicity. NOAEL, maternal toxicity= 1021 mg/kg bw/day; NOAEL, developmental toxicity= 1763 mg/kg bw/day
|
Read-across: No evidence of developmental toxicity. NOAEL, maternal toxicity= 1291 mg/kg bw/day; NOAEL, developmental toxicity= 2230 mg/kg bw/day
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Based on experimental data, the read-across approach is applied and the substance is considered as negative for the in vivo micronucleus assay. - Executive summary:
The substance CAS 15968-01-1 (disodium phthalate) is the sodium salt of the phthalic acid CAS 88-99-3. The main assumption is that sodium is not significant in respect of all the properties under consideration. In dilute aqueous conditions of defined pH a salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. Therefore, the results obtained with the substance CAS 88-99-3 can be used for the read-across approach.
Based on experimental data, the read-across approach is applied and the substance is considered as negative for the in vivo micronucleus assay.
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