Registration Dossier
Registration Dossier
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: 287-477-0 | CAS number: 85535-85-9
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data (study completed 01.12.1987)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to the final RAR on SCCPs (EU, 2000), this was a well conducted study, "performed to modern protocols".
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
- Principles of method if other than guideline:
- Frequency of mutant colonies assessed in a gene mutation (HPRT) assay with a C10-13 chlorinated paraffin (56% chlorination)
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- short-chain chlorinated paraffins
- IUPAC Name:
- short-chain chlorinated paraffins
- Reference substance name:
- 85535-84-8
- Cas Number:
- 85535-84-8
- IUPAC Name:
- 85535-84-8
- Reference substance name:
- Alkanes, C10-13, chloro
- EC Number:
- 287-476-5
- EC Name:
- Alkanes, C10-13, chloro
- IUPAC Name:
- 287-476-5
- Details on test material:
- - Name of test material (as cited in study report): Chlorparaffin 56 flϋssig
- Molecular formula (if other than submission substance): CxH(2x-y+2)Cly, where x=10-13 and y=1-13
- Molecular weight (if other than submission substance): 320-500
- Smiles notation (if other than submission substance): no data
- InChl (if other than submission substance): no data
- Substance type: technical product
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C10-13 chlorinated paraffin (56% chlorination)
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- hypoxanthine phosphoribosyltransferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: no data- Properly maintained: no data- Periodically checked for Mycoplasma contamination: no data- Periodically checked for karyotype stability: no data- Periodically "cleansed" against high spontaneous background: no data
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver metabolic activation
- Test concentrations with justification for top dose:
- 0, 5, 10, 15, 20 or 30 µg/ml without S90, 5, 10, 30, 50 or 75 µg/ml with S9
- Vehicle / solvent:
- no data
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in mediumDURATION- Preincubation period: no data- Exposure duration: no data- Expression time (cells in growth medium): no data- Selection time (if incubation with a selection agent): no data- Fixation time (start of exposure up to fixation or harvest of cells): no dataSELECTION AGENT (mutation assays): 6-thioguanineNUMBER OF REPLICATIONS: two independent experiments performedNUMBER OF CELLS EVALUATED: no dataDETERMINATION OF CYTOTOXICITY - Method: cloning efficiency
- Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Effects of pH: no data- Effects of osmolality: no data- Evaporation from medium: no data- Water solubility: soluble up to 750 ug/ml- Precipitation: no data RANGE-FINDING/SCREENING STUDIES: a preliminary study to determine cytotoxicity was conducted to select appropriate dose levels for the main study. The test substance produced a cytotoxic effect from 50 ug/mL with S9 and from 20 ug/mL without S9, up to the limit of solubility (750 ug/mL).COMPARISON WITH HISTORICAL CONTROL DATA: no dataADDITIONAL INFORMATION ON CYTOTOXICITY: cytotoxicity was evident at 20 ug/ml and above without S9 and at 50 ug/ml and above with S9
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative C10-13 chlorinated paraffin; 56% chlorinationIn a well-conducted gene mutation (HPRT) study in Chinese hamster V79 cells, Chlorparaffin 56 flϋssig (a C10-13 chlorinated paraffin; 56% chlorination) did not induce a significant, reproducible increase in mutant frequency at doses of up to 75 or 30 µg/ml respectively, with or without a rat liver metabolic activation fraction.
- Executive summary:
- Chlorparaffin 56 flϋssig (a C10-13 chlorinated paraffin; 56% chlorination) was assessed for its mutagenic potential in mammalian cells using the HPRT assay. After a preliminary study to determine cytotoxicity of the test substance, it was tested at concentrations of up to 75 or 30 µg/ml with or without a rat liver metabolic activation system (S9), respectively, in cultures of Chinese hamster lung fibroblast (V79) cells. Mutants were selected by their resistance to 6-thioguanine. Two independent experiments were conducted. According to an expert review (EU, 2000) on SCCPs, the study was well-conducted and carried out to modern protocols. The test substance did not induce an increase in mutant frequency; cytotoxicity was evident at levels of 50 or 20 µg/ml with or without S9, respectively. In contrast positive control substances (not specified in the available abstract of the report) performed as expected, increasing the mutant frequency, thus demonstrating the validity of the assay. In conclusion, in a gene mutation (HPRT) study in Chinese hamster V79 cells, Chlorparaffin 56 flϋssig did not induce a significant, reproducible increase in mutant frequency at doses of up to 75 or 30 µg/ml respectively, with or without S9.
In view of the similarities in structure and physiochemical properties [between SCCPs and MCCPs], it can be predicted that MCCPs would also be negative in a HPRT study.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.