Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 251-780-6 | CAS number: 33996-33-7
- 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
Oxaceprol did not show genetic toxicity in studies according to OECD 471 (Ames test) (in vitro gene mutation study in bacteria) and an in vitro cytogenicity study in mammalian cells.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-02-02 to 2001-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyowa Hakko Kogyo Co., Ltd. / lot 000703
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble - Target gene:
- Histidine mutation: His C3076, His D3052, His G46
Additional mutations: LPS (rfa), Repair (uvrB), R-factor (plasmid pKM 101) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- WP2uvrA-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Preliminary toxicity study: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 1500 and 5000 µg/plate
Range finding study: 50, 150, 1500 and 5000 µg/plate
Main study: 50, 150, 1500 and 5000 µg/plate Justification for top dose: Results of preliminary study and range finding study - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Oxaceprol is highly soluble in water - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: In addition, historical values
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: (plate incorporation); preincubation
DURATION
- Exposure duration: 48 h
SELECTION AGENT (mutation assays): base pair substituation and frameshift type
NUMBER OF REPLICATIONS: 3 per concentration - Evaluation criteria:
- The test material may be considered positive in the test system if the following criteria is met:
The test material should have induced a reproducible, dose-reated and statistically [Dunnett's method of linear regression (5)] significant increase in the revertant count in at least one strain of bacteria. - Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2uvrA-
- 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:
- not valid
- Additional information on results:
- From the results obtained in the experiments it appeared that incubation of the test substance with the bacteria did not increase the number of his+ revertants with S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and WP2uvrA-, either in the absence or in the presence of the S-9 mix.
The test substance appeared not to be toxic.
The positive controls used in the present assays gave the expected strong increase in the number of his+ revertants, both in the absence and in the presence of the S-9 mix. - Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Conclusions:
- Oxaprenol is considered to be non-mutagenic under the condistions of the test.
- Executive summary:
The potential of causing genetic toxicity by Oxaceprol was investigated in a Stuy according to OECD 471 (Ames-test).
From the results obtained in the experiments it appeared that incubation of the test substance with the bacteria did not increase the number of his+ revertants with S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and WP2uvrA-, either in the absence or in the presence of the S-9 mix.
The test substance appeared not to be toxic.
The positive controls used in the present assays gave the expected strong increase in the number of his+ revertants, both in the absence and in the presence of the S-9 mix.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-01-24 to 2001-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Requirements of the Japanese Chemical Substance Law (METI) for assessing chromosomal mutagenicity of a test material on the metaphase of the Chinese Hamster Lung (CHL) cell. Method similar to OECD 473.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: In vitro chromosome aberration test
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyowa Hakko Kogyo Co., Ltd. / batch 000703
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble - Species / strain / cell type:
- other: Chines Hamster LUng (CHL) cells
- Details on mammalian cell type (if applicable):
- The HL cell line, isolated by Koyame et al. (1970) and cloned by Ishidate and Sofuni (1985) was used. The CHL cell line has an average generation time ox approximately 17 h when growing under normal experimenatl conditions.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test (cell growth inhibition test): 6.76 to 1730 µg/ml.
Main tests: 0, 216.25, 432.5, 865, 1730 µg/ml. Justification for top dose: Results from preliminary toxicity test. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Oxaceprol is highly soluble in water - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- In addition: Historical data on controls
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 16 - 72 h
- Exposure duration: 24 h, 48 h
NUMBER OF REPLICATIONS: 2 per concentration
CRITERIA FOR MICRONUCLEUS IDENTIFICATION:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index, cell counts - Evaluation criteria:
- In all circumstances where increase in the frequency of cells with aberrations are seen, statistical comparisons will be made with the vehicle. A positive response was recorded for a particuliar treatment if the percentage of cells with aberrations, excluding gaps, makredly exceeded that seen in the concurrent control, either with or without a clear dose-relationship. For modest increases in aberation frequency a dose response relationship is generally required and appropriate statistical tests may be applied in order to record a positive response.
- Statistics:
- Not required.
- Key result
- Species / strain:
- other: Chinese Hanster Cells (CHL)
- 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
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Conclusions:
- Oxaceprol did not induce any statistically significant, dose-related increases in the frequency of cells with chromosome aberrations either in the presence of a liver enzyme metabolising system or after various exposre times. Therefore Oxaceprol is cosidered to be non-clastogenic to CHL cells in vitro.
- Executive summary:
An in vitro cytogenicity study in mammalian cells was performed in order to assess the potentil chromosome mutagenicity of Oxaceprol. The test was performed in accordance with the requirements of the Japanes New Chemical Suvstance Law (METI). The test method is similiar to the OECD guideline 473.
Oxaceprol did not induce any statistically significant, dose-related increases in the frequency of cells with chromosome aberrations either in the presence of a liver enzyme metabolising system or after various exposure times. Therefore Oxaceprol is considered to be non-clastogenic to CHL cells in vitro.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Oxaceprol did not show genetic toxicity in studies according to OECD 471 (Ames test) (in vitro gene mutation study in bacteria) and an in vitro cytogenicity study in mammalian cells.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.