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EC number: 605-263-0 | CAS number: 161611-74-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 18-Jan-2017 to 07-Mar-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD test Guideline No. 442C.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- 04 February 2015
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Assessed on 07-11, 14 and 16 September 2015. Dated on the 03 November 2015.
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- 605-263-0
- EC Number:
- 605-263-0
- Cas Number:
- 161611-74-1
- Molecular formula:
- C4F6O3
- IUPAC Name:
- 605-263-0
- Test material form:
- liquid
- Details on test material:
- - Physical state: Colourless liquid; odorless
- Storage condition of test material: At room temperature
Constituent 1
- Specific details on test material used for the study:
- Test item preparation:
A correction factor of 1.044 was applied for the purity of the test item.
Solubility of the test item was assessed before performing the DPRA assay. An appropriate solvent dissolved the test item completely, i.e. by visual inspection the solution had to be not cloudy nor have noticeable precipitate. The following solvent was evaluated: acetonitrile (ACN).
Perfluoro methoxy dioxole stock solutions were prepared freshly for each reactivity assay.
For both the cysteine and lysine reactivity assay, 985.9 μL of cold ACN was pipetted into an amber glass vial and 14.1 μL of ice-cold Perfluoro methoxy dioxole was added. Visual inspection of the forming of a clear solution was considered sufficient to ascertain that the test item was dissolved. The 100 mM test item solution in ACN was directly used for sample preparation and was kept at room temperature in a closed amber vial during this time. The test item, positive control and peptide samples were prepared less than 50 minutes before starting the incubation of the cysteine (cys) or lysine (lys) reactivity assays.
In chemico test system
- Details on the study design:
- See section "Any other information on materials and methods incl. tables"
Results and discussion
- Positive control results:
- Cinnamic aldehyde was used as a positive control.
- Result of positive control samples in cysteine assay: Mean of SPCC depletion = 72.0% and SD = 0.8%
- Result of positive control samples in lysine assay: Mean of SPCL depletion = 43.5% and SD = 2.1%
The mean percent peptide depletion values for the positive control with its standard deviation value were within the acceptability criteria for the DPRA assay (cysteine and lysine reactivity assays).
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Mean SPCC and SPCL depletion
- Remarks:
- (%)
- Value:
- 45.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Reference controls
- Positive controls validity:
- valid
- Remarks on result:
- other: High reactivity
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not applicable
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline: Not specified
Any other information on results incl. tables
Acceptability of the cysteine reactivity assay
The correlation coefficient (r2) of the SPCC standard calibration curve was 0.995. Since the r2 was >0.990, the SPCC standard calibration curve was accepted.
The mean peptide concentration of Reference Controls A was 0.534 ± 0.011 mM while the mean peptide concentration of Reference Controls C was 0.534 ± 0.009 mM. The mean Reference Control samples A and C were both within the acceptance criteria of 0.50 ± 0.05 mM. This confirms the suitability of the HPLC system and indicates that the solvent (ACN) used to dissolve Perfluoro methoxy dioxole did not impact the Percent SPCC Depletion.
The Coefficient of Variation (CV) of the peptide areas for the nine Reference Controls B and C was 1.9%. This was within the acceptance criteria (CV <15.0%) and confirms the stability of the HPLC run over time.
The mean area ratio (A220/A258) of the Reference Control samples was 18.33. The mean A220/A258 ratio ± 10% range was 16.50-20.16. Each sample showing an A220/A258 ratio within this range gives an indication that co-elution has not occurred.
Acceptability of the lysine reactivity assay
The correlation coefficient (r2) of the SPCL standard calibration curve was 0.994. Since the r2 was >0.990, the SPCL standard calibration curve was accepted.
The mean peptide concentration of Reference Controls A was 0.492 ± 0.007 mM while the mean peptide concentration of Reference Controls C was 0.482 ± 0.007 mM.
The mean Reference Control samples A and C were both within the acceptance criteria of 0.50 ± 0.05 mM. This confirms the suitability of the HPLC system and indicates that the solvent (ACN) used to dissolve Perfluoro methoxy dioxole did not impact the Percent SPCL Depletion.
The CV of the peptide areas for the nine Reference Controls B and C was 1.9%. This was within the acceptance criteria (CV <15.0%) and confirmed the stability of the HPLC run over time.
The mean area ratio (A220/A258) of the Reference Control samples was 13.98. The mean A220/A258 ratio ± 10% range was 12.58-15.38. Each sample showing an A220/A258 ratio within this range gives an indication that co-elution has not occurred.
SPCC and SPCL depletion and reactivity classification for the test substance
Test item | SPCC depletion | SPCL depletion | Mean of SPCC and | Reactivity class | ||
Mean | +/- SD | Mean | +/- SD | SPCL depletion | Cysteine 1:10 / Lysine 1:50 prediction model | |
83.4% | +/- 3.6% | 8.4% | +/- 3.4% | 45.9% | High reactivity |
Applicant's summary and conclusion
- Interpretation of results:
- other: High reactivity
- Conclusions:
- Perfluoro methoxy dioxole was positive in the DPRA and was classified in the “high reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
- Executive summary:
The skin sensitisation potential of Perfluoro methoxy dioxole was evaluated using an in chemico direct peptide binding assay (DPRA) according to the OECD Guideline No. 442C and in compliance with GLP.
Following 24 hours of incubation of Perfluoro methoxy dioxole with either SPCC or SPCL, the relative peptide concentration was determined by High-Performance Liquid Chromatography (HPLC) with gradient elution and photodiode array (PDA) detection at 220 nm and 258 nm. SPCC and SPCL Percent Depletion Values were calculated and used in a prediction model which allows assigning the test chemical to one of four reactivity classes used to support the discrimination between sensitisers and non-sensitisers.
The validation parameters, i.e. calibration curve, mean concentration of Reference Control (RC) samples A and C, the CV for RC samples B and C, the mean percent peptide depletion values for the positive control with its standard deviation value and the standard deviation value of the peptide depletion for Perfluoro methoxy dioxole were all within the acceptability criteria for the DPRA assay.
No co-elution of the test item with SPPC or SPCL was observed.
In the cysteine reactivity assay Perfluoro methoxy dioxole showed 83.4% SPCC depletion while in the lysine reactivity assay Perfluoro methoxy dioxole showed 8.4% SPCL depletion. The mean of the SPCC and SPCL depletion was 45.9% and as a result Perfluoro methoxy dioxole was classified in the “high reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model. Therefore, Perfluoro methoxy dioxole was considered to be positive in the DPRA.
It can be concluded that this DPRA test is valid.
Perfluoro methoxy dioxole was positive in the DPRA and was classified in the “high reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
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