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Diss Factsheets
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EC number: 950-299-5 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- secondary source
- Title:
- Chlorinated paraffins
- Author:
- IPCS
- Year:
- 1 996
- Bibliographic source:
- Environmental Health Criteria 181
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- This test system does not have the ability to detect certain oxidising or cross-linking mutagens
- GLP compliance:
- no
- Remarks:
- Data audited by RBM S.p.A. quality assurance unit
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alkanes, C14-17, chloro
- EC Number:
- 287-477-0
- EC Name:
- Alkanes, C14-17, chloro
- Cas Number:
- 85535-85-9
- Molecular formula:
- Substance is a range of chlorinated isomers of C14 to C17 paraffin
- IUPAC Name:
- Alkanes, C14-17, chloro
- Details on test material:
- - Name of test material (as cited in study report): Solvocaffaro C1642
- Substance type: technical product
- Physical state: pale yellow liquid
- Analytical purity: no data
- Composition of test material, percentage of components: a C14-17 n-paraffin, 42% chlorination
- Impurity: no details on presence or absence of a stabiliser
- Lot/batch No.: Gi 2/88
Constituent 1
Method
- Target gene:
- histidine biosynthesis
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Obtained from the liver of male rats administered Aroclor 1254
- Test concentrations with justification for top dose:
- 1, 10, 100, 1000 and 5000 µg/plate (but erroneously reported as up to 5000 mg/plate in the draft EU RAR, 2008).
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Hydrazine sulphate, 9-aminoacridine-HCl, doxorubicine HCl, 2-aminofluorene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in mediumDURATION- Preincubation period: none- Exposure duration: 72 hNUMBER OF REPLICATIONS: 3 plates/dose level; duplicate experiments carried out on separate occassions.
- Evaluation criteria:
- Test article considered positive if the mean number of revertant colonies is significantly greater than controls and a dose-response is verified over at least 3 doses
- Statistics:
- Student's t-test for comparison of numbers of revertants between test and control incubations and linear regression test for dose-response evaluation.
Results and discussion
Test resultsopen allclose all
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- no data
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Data erroneously reported for Salmonella typhimurium strain TA199 in IPCS EHC 181 (1996), should read strain TA100
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative C14-17 chlorinated paraffin; 42% chlorinationThe C14-17 chlorinated paraffin (Solvocaffero C1642) was not mutagenic in the Ames assay with five Salmonella typhimurium strains, with or without the addition of a rat liver metabolic activation system.
- Executive summary:
In an OECD 471 guideline study, a C14-17 chlorinated paraffin (Solvocaffero C1642; 42% chlorination) was tested in the Ames assay with and without rat liver metabolic activation (S9) at up to a maximum concentration of 5000 µg/plate. The bacterial strains used were Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538. (This test system does not have the ability to detect cross-linking or certain oxidising mutagens). Negative and positive control groups validated the study.
Solvocaffero C1642 did not induce any significant increase in the number of reversions compared to controls, both in the presence or absence of S9, when tested up to 5 mg/plate on two separate occasions. Therefore this C14-17 chlorinated paraffin is considered to be non-mutagenic under the conditions of the test.
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