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EC number: 203-137-6 | CAS number: 103-71-9
- 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
Several Ames tests with phenyl isocyanate are available. In the reliable studies including the key study (guideline study) the test showed a clear negative result.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientific acceptable and well documented - only 4 strains tested
- Principles of method if other than guideline:
- The mutagenic potential of phenyl isocyanate was examined in the Salmonella/microsome test. Bacteria of four histidine auxotrophic Salmonella typhimurium LT2 mutant strains (TA 98, TA 100, TA 1535, and TA 1537) were exposed to doses up to 12500 µg per plate.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: Firstly, they are deep rough since certain lipopolysaccharide side chains are missing in the bacterial cell wall. Secondly, their reduced ability to repair damage from UV light (e.g. thymidine dimers) allows the phenotypic detection of mutation events
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 20, 100. 500, 2500, 12500 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Endoxan, Trypaflavin
- Details on test system and experimental conditions:
- Ames test
- Key result
- 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
- Remarks:
- up to 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
- Executive summary:
The mutagenic potential of phenyl isocyanate was examined in the Salmonella/microsome test. Bacteria of four histidine auxotrophic Salmonella typhimurium LT2 mutant strains (TA 98, TA 100, TA 1535, and TA 1537) were exposed to doses up to 12500 µg per plate.
There was no evidence for mutagenic effects of phenyl isocyanate with and without S9 mix. A biologically relevant increase of revertant colony numbers over control levels was not observed. Therefore, phenyl isocyanate was considered to be non-mutagenic in the Salmonella/microsome test.
Reference
Doses up to 2500 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no growth inhibition was observed. Substance precipitation occurred at the dose of 2500 µg per plate and above.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Two micronucleus tests in the mouse are available.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- The micronucleus test was employed to investigate phenyl isocyanate in male and female mice for a possible clastogenic effect on the chromosomes of bone-marrow erythroblasts. The known clastogen and cytostatic agent, cyclophosphamide, served as positive control. The treated animals received a single intraperitoneal administration of either phenyl isocyanate or cyclophosphamide.
The femoral marrow of groups treated with phenyl isocyanate was prepared 24, 48 and 72 hours after administration. All negative and positive control animals were sacrificed after 24 hours. The doses of phenyl isocyanate and the positive control, cyclophosphamide, were 30 and 20 mg/kg body weight, respectively. - GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- The femoral marrow of groups treated with phenyl isocyanate was prepared 24, 48 and 72 hours after administration.
- Frequency of treatment:
- single intraperitoneal administration
- Post exposure period:
- Animals were sacrificed 24, 48 and 72 hours after the administration, and the femoral marrow was prepared
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 30 mg/kg bw/day
- No. of animals per sex per dose:
- 5 male and 5 female mice/dose
- Control animals:
- yes, concurrent vehicle
- Tissues and cell types examined:
- Femoral marrow
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
- Executive summary:
The micronucleus test was employed to investigate phenyl isocyanate in male and female mice for a possible clastogenic effect on the chromosomes of bone-marrow erythroblasts. The known clastogen and cytostatic agent, cyclophosphamide, served as positive control.
The treated animals received a single intraperitoneal administration of either phenyl isocyanate or cyclophosphamide. The femoral marrow of groups treated with phenyl isocyanate was prepared 24, 48 and 72 hours after administration. All negative and positive control animals were sacrificed after 24 hours. The doses of phenyl isocyanate and the positive control, cyclophosphamide, were 30 and 20 mg/kg body weight, respectively.
The animals treated with phenyl isocyanate showed lasting symptoms of toxicity after administration. One of forty animals died before the end of the test due to the acute intraperitoneal toxicity of 30 mg/kg phenyl isocyanate.
There was an altered ratio between polychromatic and normochromatic erythrocytes. No indications of a relevant clastogenic effect of phenyl isocyanate were found after a single intraperitoneal treatment with 30 mg/kg.
Reference
The animals treated with phenyl isocyanate showed lasting symptoms of toxicity after administration. One of forty animals died before the end of the test due to the acute intraperitoneal toxicity of 30 mg/kg phenyl isocyanate. There was an altered ratio between polychromatic and normochromatic erythrocytes.
No indications of a relevant clastogenic effect of phenyl isocyanate were found after a single intraperitoneal treatment with 30 mg/kg.
Cyclophosphamide, the positive control, had a clear clastogenic effect, as is shown by the biologically relevant increase in polychromatic erythrocytes with micronuclei. The ratio of polychromatic to normochromatic erythrocytes was not altered.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Several Ames tests with phenyl isocyanate are available. In the reliable studies including the key study (guideline study) the test showed a clear negative result.
In other Ames tests with Salmonella typhimurium or Streptomyces the test had an ambiguous or positive result. Due to methodological deficiencies and limited documentation these results are not assignable. By a weight-of-evidence consideration, phenyl isocyanate is regarded as negative in the Ames test.
No chromosome aberration or mammalian cell gene mutation assay in vitro are available.
Two micronucleus tests in the mouse were negative.
Justification for classification or non-classification
Several Ames tests with phenyl isocyanate are available. In the reliable studies including the key study (guideline study) the test showed a clear negative result, however only 4 stains ( S. typhimurium TA 1535, TA 1537, TA 98 and TA 100). Phenyl isocyanate has no oxidising properties, is no cross-linking agent and no hydrazine derivative: Therefore testing in S. typhimurium TA 102 seems unnecessary.
Additionally 2 reliable chromosome aberration tests in the mouse are available. Both in vivo tests are negative.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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