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EC number: 222-079-2 | CAS number: 3338-24-7
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation study in bacteria (OECD 471, read across structural analogue) - negative
In vitro cytogenicity in mammalian cells (OECD 473, read across structural analogue) - negative
In vitro gene mutation study in mammalian cells (OECD 476, read across structural analogue) - negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
Under the present test conditions IBP1-Na, tested up to a cytotoxic concentration, caused no mutagenic effect in the Chinese hamster lung fibroblasts (V79) carried out without and with metabolic activation.
Remark: The test solution contains NaOH due to the production method.
Due to the similarity of the target substance, EP1-Na, and the source substance, IBP1-Na, the result of this study is assessed to be adequate in order to fulfil the requirements of REACH. The read-across approach is further described in the document “Justification of read across from CAS No 53378-51-1 IBP1-Na (source) to CAS No 3338-24-7, EP1-Na (target)” attached in “Point 13 Assessment reports”. - Executive summary:
The test was performed according to the OECD Guideline 476 under GLP compliance. Chinese hamster lung fibroblasts was used as strain. Metabolic activation was used both with and without. Blank, vehicle control and positive control was tested. No genotoxicity, no cytotoxicity was detected.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- mammalian cell line, other: human peripheral lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity was noted in the experiment without and with metabolic activation (24-h and 4-h exposure) at 2500 µg IBP1-Na /mL. Haemolysis was noted at the concentration of 2500 µg/mL in both experiments.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
Under the present test conditions, the substance IBP1-Na, tested up to cytotoxic concentrations, in the absence and in the presence of metabolic activation employing two exposure times (without S9) and one exposure time (with S9) revealed no indications of mutagenic properties with respect to chromosomal or chromatid damage.
Remark: the test solution contains NaOH due to the production method.
In the same test, Mitomycin C and cyclophosphamide induced significant damages, which confirmed the validity of this assay.
Due to the similarity of the target substance EP1-Na and the source substance, IBP1-Na, the result of this study is assessed to be adequate in order to fulfill the requirements of REACH. The read-across approach is further described in the document “Justification of read across from CAS No 53378-51-1 IBP1-Na (source) to CAS No 3338-24-7, EP1-Na (target)” attached in “Point 13 Assessment reports”. - Executive summary:
The test was performed according to the OECD guideline 473 under GLP compliance. Human peripheral lymphocytes was used for test. Metabolic activation was used both with and without. Blank, vehicle control and positive control was tested. No genotoxicity was detected, cytotoxicity was noted in the experiment without and with metabolic activation (24-h and 4-h exposure) at 2500 µg test item/mL. Haemolysis was noted at the concentration of 2500 µg/mL in both experiments.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Read Across Statement attached in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
Under the present test conditions the substance, IBP1-Na, tested up to a concentration of 5000 µg i-Butyl-dtp-Na/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Remark: the test solution contains NaOH due to the production method. - Executive summary:
The test was performed according to the OECD guideline 471 under GLP compliance. S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strain were used. Metabolic activation was used both with and without. Vehicle control, blank and positive control was tested. No genotoxicity, no cytotoxicity was detected.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available information on the read-across substance, EP1-Na is not required to be classified for mutagenicity according to Regulation (EC) No 1272/2008.
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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