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EC number: 201-132-3 | CAS number: 78-67-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test substance showed no genotoxicity in two bacterial gene reverse mutations tests with and without metabolic activation.
Additionally, the results of a chromosomal aberration test using cultured Chinese Hamster Lung (CHL/IU) cells were negative for genotoxicity.
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:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Only 4 strains used. Less positive controls.
- Principles of method if other than guideline:
- Method according to Ames, B.N. et al.: Mutat. Res. 31, 347-364
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- common name: Porofor N, Pt. 23091979
- Target gene:
- his
- Species / strain / cell type:
- other: Salmonella typhimurium TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver microsomes
- Test concentrations with justification for top dose:
- 20; 100; 500; 2,500; 12,500 ug/plate
- Vehicle / solvent:
- - DMSO for Porofor N, Trypaflavin and 2-aminoanthracene
- deion. water for Endoxan - Untreated negative controls:
- other: vehicle control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Endoxan (Cyclophosphamid); Trypaflavin; 2-Aminoanthracene.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- at 12,500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
Based on the results of this study, the test substance Porofor N does not need to be classified according to EC/1272/2008 and 67/548/EEC. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1997
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his, trp
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9, induced with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- 0; 313; 625; 1250; 2500 and 5000 µg/plate.
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Conclusions:
- Interpretation of results: negative
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1997
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- other: Chinese hamster lung (CHL/IU) cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver, induced with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- +/- S9 mix (short-term/continous treatment): 0; 0.4; 0.8; 1.6 mg/mL
- Species / strain:
- other: CHL/IU
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Conclusions:
- Interpretation of results: negative
Referenceopen allclose all
Since precipitation of the test substance was observed at 12,500 µg/plate, this dose level could not be evaluated.
Precipitation observed at 1250 µg/plate (with metabolic activation) and 2,500 µg/plate (without metabolic activation).
No signs of clastogenicity or polyploidy was found in the chinese hamster lung (CHL/IU) cells with or without metabolic activation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
The test substance showed no genotoxicity in a micronucleus test in mice.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Principles of method if other than guideline:
- Acredine orange staining
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- double oral administration
- Remarks:
- no data
- Sex:
- male
- Genotoxicity:
- negative
Reference
negative
The mice were given a double oral dose of the test substance. At both 24
and 48 h after treatment, bone marrow
smears were prepared. Administration of the test substance did not
result in a significant increase in the frequency of micronucleated
polychromatic erythrocytes.
Only abstract available; no further data.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in vitro
Ames test with and without metabolic activation with S9 mix prepared from liver homogenate of Aroclor 1254 pretreated male Sprague-Dawley rats was conducted. At the highest dose level, precipitation of the test substance was observed. The results were not assignable. Neither cytotoxicity nor mutagenicity was observed at doses up to 2500 µg/plate. Therefore, the test substance was considered to be not mutagenic in the Ames assay. (BASF, 1980)
Genetic toxicity in vivo
The mice were given a double oral dose of the test substance. At both 24 and 48 h after treatment, bone marrow smears were prepared. Administration of the test substance did not result in a significant increase in the frequency of micronucleated polychromatic erythrocytes. (Takenaka, 1993)
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No adverse findings on genotoxicity was observed in in vitro or in vivo studies. As a result the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.
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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