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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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 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
- 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
- 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.
- Endpoint:
- skin irritation: 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 f..JL test item were applied
- Duration of treatment / exposure:
- Tissues were dosed in one minute intervals. After 24 minutes, all plates are transferred into the incubator for 35 min.. 60 min. after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in one-minute-intervals.
- Duration of post-treatment incubation (if applicable):
- 18 ± 2 hours for post-incubation
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- ca. 10.6
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item is considered irritant. Study No.: 1 0092802G840. Test ltem: Deophos 228. After the treatment, the relative absorbance values were decreased to 10.6%. This value is weil below the threshold for irritation (50%). The optical density of the negative control was weil within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 7.0% (required: ~ 20%) for thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item. For these reasons, the result of the test is considered valid.
- Executive summary:
One valid experiment was performed. Three tissues of the human skin model EpiDerm TM were treated with the test substance for 60 minutes. 30 1-JL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size. DPBS-buffer was used as negative control, 5% SOS-solution was used as positive control. After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%). After the treatment with the test item, the relative absorbance values were reduced to 10.6 %. This value is weil below the threshold for irritation potential (50%). Therefore, the test substance 228 is considered as irritant in the Human Skin Model Test.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- 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)
- 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.
- 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
- 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
One valid experiment was performed. Three tissues of the human skin model EpiDerm TM were treated with the test substance for 60 minutes. 30 1-JL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size. DPBS-buffer was used as negative control, 5% SOS-solution was used as positive control. After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%). After the treatment with the test item, the relative absorbance values were reduced to 10.6 %. This value is weil below the threshold for irritation potential (50%). Therefore, the test substance 228 is considered as irritant in the Human Skin Model Test.
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.
Justification for classification or non-classification
Skin irritation:
Based on the results of the in vitro skin irritation studies, the substance is considered to be irritant to skin and hence warrants a classification as Skin Irrit. 2 ( H315: Causes skin irritation) according to EU CLP (1272/2008/EC) criteria.
Eye irritation:
Considering the results of the in vitro eye irritation study, the substance does not warrant any classification for eye irritation according to EU CLP (1272/2008/EC) criteria.
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.