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Diss Factsheets
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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
Hydrolysis
The test material Santicizer 2148 plasticizer is a mixture of five organic esters prepared from phosphoric acid. According to the Guideline EEC C7. 'Abiotic degradation: hydrolysis as a function of pH, December 1992', the test concentration should not exceed the lesser of 0.1 M or half the water solubility. For the test material (water solubility = 0.15 mg/L) that meant that the test concentration in the hydrolysis study had to be <0.08 mg/L.
The analytical method used to determine the test material concentrations in the hydrolysis study should be able to measure a decrease in concentration of at least
10% accurately. Neither High Performance Liquid Chromatography (HPLC) not Gas Chromatography (GC) were sensitive enough to measure such a low
concentration accurately. Therefore, the hydrolysis study was technically not feasible and could not be performed.
Biodegradation
Based on the poor water solubility of the test material in water (water solubility = 0.15 mg/L) and significant volatilization in water, none of the available test methods (OECD 301A - 301F) were found to be suitable for the determination of ready biodegradability.
Bioaccumulation
A key EPA OPP Guideline 165-4 dynamic 56-day study (ABC Laboratories Inc., 1993a) was conducted to evaluate the bioaccumulation of 14C-Santicizer 2148 by Bluegill Sunfish (Lepomis macrochirus). A flow-through proportional diluter system was used to maintain a mean measured water concentration of 0.097 (± 0.015) μg/L14C-Santicizer 2148 for a 35-day exposure period. Radioanalysis of fillet, whole fish, and visceral portions was performed periodically during the exposure period. In this study the fillet (body, muscle, skin, and skeleton) was considered the edible portion of the fish, while the viscera (fins, head, and internal organs) was considered the nonedible portion. Daily bioconcentration factors ranged from 22 to 210 x, 12 to 760 x, and 19 to 1300 x for fillet, whole fish, and viscera respectively. Average tissue concentrations of 14C-Santicizer 2148 during the exposure phase ranged from 2.4 to 21 ng/g for fillet, 1.4 to 74 ng/g for whole fish, and from 2.3 to 130 ng/g for viscera. The bioaccumulation of 14C-Santicizer 2148 in all tissues was consistent through day 28 uptake and by day 35 of uptake the rate slowed considerably in the fillet tissue. Since the accumulation appeared to be continuous in the whole fish and viscera tissues the uptake was terminated on day 35 and depuration was started.
To measure the elimination of 14C-Santicizer 2148, the test fish were placed in untreated water for 21 days. Radioanalysis at the end of the 21-day depuration period indicated 40, 64, and 73% depuration from fillet, whole fish, and viscera respectively. Fillet concentrations dropped from 20 ng/g on day 35 of exposure to 12 ng/g by day 21 of depuration. Whole fish levels decreased from 74 ng/g on day 28 of exposure to 27 ng/g by the end of depuration, while viscera concentrations dropped from 130 ng/g on day 35 of exposure to 35 ng/g by day 21 of depuration.
Analysis of the uptake/depuration data for whole fish was conducted using a computer modelling program. This method estimated the uptake rate constant (K1) ng/g fish perμg/L water per day of 56 ± 2, depuration rate constant (K2) day-1 of 0.064 ± 0.003, time for 50% depuration of 11 ± 0.5 days, bioconcentration factor (BCF) of 875 ± 50, and a time to reach 90% of stead state 36 ± 2 days. The BIOFAC-calculated BCF value was 115% of the observed mean whole fish bioconcentration factor of 760 x for day 35.
Test fish were in good health during the study and no mortality was observed in the treated and control aquaria. Therefore, the data obtained from these fish adequately defined the uptake/depuration of potential 14C-Santicizer 2148.
Adsorption
The adsorption coefficient (KOC) in soil and on sewage sludge was estimated using HPLC (NOTOX B.V., 1999i). According to the information supplied by the sponsor, SANTICIZER 2148 PLASTICIZER is a mixture of five organic esters prepared from phosphoric acid. For the five phosphoric acid esters, the log KOC and KOC were given as a range of 6.1 - 7.3 and (0.13-2.0)*107, respectively.
Additional information
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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