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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- Deviations:
The following deviations from the study plan were observed:
+ Cuvettes with a pathlength of 0.2 cm were used in the measurement of the Fluorescein-
Na solution in the spectrophotometer and all absorptions were multiplied with
the coefficient 5. The deviation was considered as uncritical since the test results
were not influenced.
+ The positive control benzalkonium chloride solution (5%) was dissolved in demineralised
water instead of 0.9% sodium chloride solution. The deviation can be seen as
uncritical since it was incorrectly stated in the study plan.
The deviations were assessed and signed by the deputy study director on 11. Jan. 2011. - 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
Test animals / tissue source
- Species:
- other: bovine eyes
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Freshly bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank's balanced salt solution (supplemented with 0.01% Streptomycin and 0.01% penicillin). Then the corneas were dissected and incubated with media at 32 ± 1 oc in an incubation chamber for 1 hour.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- in average, 214.3 mg of the test item were tested neat and applied directly on the cornea using a weight board. The test item was given on the epithelium in such a manner that as much as possible of the corneawas covered with test item. The test item is a surface active liquid. Surfactants (solids or liquids) are usually tested at a concentration of 10% in a 0.9% sodium chloride solution, deionised water or other solvents which have no adverse effects in the test system. The test item Deophos 228 was not soluble in one of the solvents mentioned above in the demanded concentration (10%). Since no solutionwas feasible, the test item was applied directly on the cornea without dilution or preparation of a solution.
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 90 ± 5 min
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- ca. 0.785
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
IVIS was calculated using the values in tables 9.1-a and 9. I-b and the equation stated in chapter 8.3. Example: IVIS (Deophos 228, Repl. 1) = (0.0893 - 0.2416) + [15 * (5 * 0.0142 - 0.0200)] = 0.6127
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table 9.2.a IVIS
Relative Standard Deviation IVIS |
|||
Negative Control 0,9% NaCl |
0.6757 |
0.5420 |
21.4% |
0.4836 |
|||
0.4671 |
|||
Deophos 228 |
0.6127 |
0.7850 |
|
1 .5786 |
|||
O. 1644 |
|||
Positive Control 5% Benzalkonium chloride solution |
88.5716 |
108.6360 |
17.0% |
112.4971 |
|||
124.8378 |
Note: the high relative standard deviation of the IVIS of test item is due to mathematical reasons, as the respective mean is very small.
Parameter Criterion
IVIS of ne ative control 0.9% NaCl |
0 - 3 |
Found 0.5420 |
Assessment ok |
|
IVIS of positive control 5% Benzalkonium chloride solution |
55.4 — |
108.6360 |
Too high |
Values for negative control were within the range of historical data of the test facility (see 14, page 20). Therefore, the test system was acceptable. The values for positive control were not within the range of historical data of the test facility. This can be seen as uncritical because the range of the historical data was quite narrow since it referred only to six individual replicates. Besides that, the high value of the positive control can be seen as uncritical because of the fact that it showed clearly very severe eye irritating effects which confirms that the test system is acceptable.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This in vitro study was performed to assess the corneal irritation and darnage potential of Deophos 228 by quantitative measurements of changes in opacity and permeability in a bovine cornea. The test item Deophos 228 was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without Phenol red at 32 ± 1°C for one hour and whose opacity had been determined. The lest item was incubated on the cornea for 10 minutes at 32 ± 1°C. After removal of the lest item and two hours post-incubation, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control; benzalkonium chloride (5% solution in demineralised water) was used as positive control. The positive control induced a very severe irritation on the cornea, mean IVIS was 108.6360. The negative control showed no irritation, mean IVIS was 0.5420. The lest item was tested pure. A mean IVIS of 0.7850 was calculated, corresponding to a classification as not eye irritant. No observations were made which might cause doubts concerning the validity of the study outcome. The lest is considered valid.
- Executive summary:
One valid experiment was performed. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old. The test item was brought onto the cornea of a bovine eye which had been incubated with cMEM without Phenol red at 32 ± 1°C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32 ± 1°C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea. 5% benzalkonium chloride solution was used as positive control. The positive control induced a very severe irritation on the cornea. The test item showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0. 7850. ln conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses no eye irritation potential.
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