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EC number: 271-663-3 | CAS number: 68603-55-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- Deviations:
The following deviations from the study plan were observed:
• The pre-test for the ability of direct formazan reduction was not incubated at room
temperature but in the incubation chamber at 3rC and 5% C02. The deviation can
be seen as uncritical since the SOP of MatTek and the SOP of the LAUS GmbH (118
00 820) prescribes it this way (error in study plan).
The deviationwas assessed and signed by the deputy study director on 5. Nov. 2010.
• lnstead of the analytical scales Mettier Toledo AB 184 SA, the analytical scales Mettier
Toledo XS 205 DU were used. The deviation can be seen as uncritical since the
new analytical scales work as precisely as the old analytical scales.
The deviationwas assessed and signed by the deputy study director on 9. Dec. 2010. - Deviations:
- yes
- Remarks:
- The deviation can be seen as uncritical
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, C12-14-alkyl, C6-10-alkyl phosphates
- EC Number:
- 271-663-3
- EC Name:
- Amines, C12-14-alkyl, C6-10-alkyl phosphates
- Cas Number:
- 68603-55-4
- Molecular formula:
- not available (UVCB)
- IUPAC Name:
- Amines, C12-14-alkyl, C6-10-alkyl phosphates
- Test material form:
- liquid: viscous
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Commercially available Epi-200-Kit. The EpiDerm TM tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. lt consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar Iipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The liquid test item was applied without preparation (50 µL).
- Duration of treatment / exposure:
- three minutes and one hour
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- ca. 114.4
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- ca. 113.4
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item is considered not corrosive. After three minutes treatment, the relative absorbance values were increased to 114.4%. This value is well above the threshold for corrosivity (50%). After one hour treatment relative absorbance values were increased to 113.4%. This value is well below the threshold for corrosivity (15%). The values of the negative control were well above the required acceptability criterion of mean OD>O.8 for both treatment interval thus showing the quality of the tissues. The value of the positive control induced a decrease in the relative absorbance as compared to the negative control to 30.5% for the three minutes treatment interval and 12.9% for the one hour treatment interval thus ensuring the validity of the test system. For these reasons, the result of the test is considered valid.
- Executive summary:
One valid experimentwas performed. Two tissues of the human skin model EpiDerm TM were treated with the test substance for three minutes and one hour, respectively. 50 µL of the liquid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8 m KOH was used as positive control. After treatment with the negative control the absorbance values were weil above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were increased to 114.4 %. This value is weil above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were increased to 113.4 %. This value, too, is weil below the threshold for corrosion potential (15%). Therefore, the test substance is considered as not corrosive in the Human Skin Model Test.
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