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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 May 2003 - 10 Sep 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: requirements of UK Department of Health Committee on Mutagenicity Guidelines for the Mutagenicity Testing of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Amides, C18, branched and linear
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Amides, C18, branched and linear
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- - Name of test material (as cited in study report): PERFAD FM 3337
- Physical state: cream coloured paste
- Analytical purity: 95%
- Lot/batch No.: 607459
- Storage condition of test material: at room temperature protected from light
Constituent 1
Method
- Target gene:
- Not applicable.
Species / strain
- Species / strain / cell type:
- lymphocytes: of fresh heparinised whole blood from peripheral circulation of a volunteer
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagle's minimal essential medium with HEPES buffer (MEM), supplemented with L-glutamine, penicillin/streptomycin, amphotericin B, and 15% foetal calf serum (FCS).
- Properly maintained: yes
- The lymphocytes were stimulated to divide by the addition of phytohaemagglutinin (PHA) at 90 µg/mL final concentration. - Additional strain / cell type characteristics:
- other: The volunteer donor had not been exposed to high levels of radiation or hazardous chemicals and had not knowingly recently suffered from a viral infection.
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented S9-Mix from male Sprague-Dawley rats induced with phenobarbitone (80 mg/kg bw) and ß-naphtoflavone (100 mg/kg bw); Experiment 1: 2% final concentration and Experiment 2: 1 % final concentration
- Test concentrations with justification for top dose:
- - Preliminary Toxicity Test: 19.53, 39.06, 78.13, 156.25, 312.5, 625, 1250, 2500, and 5000 µg/mL
- Experiment 1: 9.77, 19.53, 39.06, 78.13, 156.25, and 312.5 µg/mL (-/+ S9)
- Experiment 2: 9.77, 19.53, 39.06, 78.13, 156.25, and 312.5 µg/mL (-S9); 4.88, 9.77, 19.53, 39.06, 58.60, and 78.13 µg/mL (+S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- -S9: Mitomycin C (MMC) 0.4 and 0.2 µg/mL in MEM; +S9: cyclophosphamide (CP) 10 µg/mL in DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: none
- Exposure duration: 4 h (Experiment 1 and 2, +S9 and Experiment 2 +S9); 24 h ( Experiment 2 -S9)
- Expression time (cells in growth medium): 20 h (only Experiment 1 and 2, +S9 and Experiment 2 +S9)
- Fixation time (start of exposure up to fixation or harvest of cells): 24 h
SPINDLE INHIBITOR (cytogenetic assays): colcemid 0.1 µg/mL
STAIN (for cytogenetic assays): 5% Gurrs Giemsa
NUMBER OF REPLICATIONS: 2 independent experiments
NUMBER OF CELLS EVALUATED: Mitotic Index: 2000 lymphocyte cell nuclei; aberrations: 100 consecutive well-spread metaphases from each culture were counted (termination at 50 metaphases in case there were approximately 50% cells with aberrations)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A positive response was recorded for a particular treatment if the % cells with aberrations, excluding gaps, markedly exceed that seen in the concurrent control, either with or without a clear dose response relationship. For modest increase in aberration frequency a dose response relationship is generally required and appropriate statistical tests may be applied in order to record a positive response.
- Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells was compared, where necesary, with the concurrent vehicle control value using Fisher's Exact Test.
Results and discussion
Test results
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment 1: +S9 at 156.25 µg/mL, -S9 at 78.13 µg/mL; Experiment 2: +S9 at 39.06 µg/mL, - S9 at 19.53 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Precipitation: yes (at 156.25 µg/mL and above)
COMPARISON WITH HISTORICAL CONTROL DATA: The positive and vehicle control data are within the range of the laboratory's historical control data. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Tab. 1: Experiment 1: 4 h treatment, 24 h fixation - Without Metabolic Activation
Concentration |
Mitotic index [%] |
Polyploid cells |
Aberrant cells |
|
incl. gaps |
excl. gaps |
|||
Solvent control |
100 |
0.0 |
0.5 |
0.5 |
9.77 µg/mL |
96 |
0.0 |
2.5 |
2.0 |
19.53 µg/mL |
126 |
0.0 |
2.0 |
0.5 |
39.06 µg/mL |
66 |
2.0 |
3.0 |
1.5 |
MMC 0.4 µg/mL |
34 |
0.0 |
44.7 |
38.0 |
MMC: mitomycin C; solvent control: DMSO
Tab. 2: Experiment 1: 4 h treatment, 24 h fixation - With Metabolic Activation (2% S9-Mix)
Concentration |
Mitotic index [%] |
Polyploid cells |
Aberrant cells |
|
incl. gaps |
excl. gaps |
|||
Solvent control |
100 |
0.5 |
1.0 |
0.5 |
19.53 µg/mL |
110 |
1.0 |
1.5 |
0.5 |
39.06 µg/mL |
85 |
0.0 |
0.5 |
0.5 |
78.13 µg/mL |
72 |
0.0 |
0.5 |
0.5 |
CP 10 µg/mL |
15 |
0.5 |
29.5 |
22.0 |
CP: cyclophosphamide; solvent control: DMSO
Tab. 3: Experiment 2: 24 h treatment, 24 h fixation - Without Metabolic Activation
Concentration |
Mitotic index [%] |
Polyploid cells |
Aberrant cells |
|
incl. gaps |
excl. gaps |
|||
Solvent control |
100 |
0.0 |
4.0 |
2.0 |
4.88 µg/mL |
100 |
0.0 |
0.0 |
0.0 |
9.77 µg/mL |
73 |
0.0 |
2.0 |
0.5 |
19.53 µg/mL |
48 |
0.0 |
1.1 |
0.0 |
MMC 0.2 µg/mL |
26 |
0.0 |
55.0 |
45.0 |
MMC: mitomycin C; solvent control: DMSO
Tab. 4: Experiment 2: 4 h treatment, 24 h fixation - With Metabolic Activation (1% S9-Mix)
Concentration |
Mitotic index [%] |
Polyploid cells |
Aberrant cells |
|
incl. gaps |
excl. gaps |
|||
Solvent control |
100 |
0.0 |
1.5 |
1.0 |
9.77 µg/mL |
138 |
1.0 |
4.0 |
2.0 |
19.53 µg/mL |
111 |
0.0 |
1.0 |
1.0 |
39.06 µg/mL |
134 |
0.5 |
3.5 |
1.0 |
CP 10 µg/mL |
47 |
0.0 |
48.0 |
36.0 |
CP: cyclophosphamide; solvent control: DMSO
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.