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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-596-7 | CAS number: 68130-53-0
- 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
- Study period:
- 03 April 2014 to 02 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD test guidelines in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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)
- GLP compliance:
- yes
Test material
- Test material form:
- other: liquid
- Details on test material:
- Identity: H2925 (CAS No, 68130-53-0), Lot# 2013090401Supplied By: Chemtura CorporationDate Received: 18 Mar 2014Storage: Room temperature and humidityDescription: Clear yellow liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The bovine eyes were received from Spear Products on 10 Apr 2014 and transported to MB Research in Hank's Balanced Salt Solution with Penstrep in a refrigerated container.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Using the closed chamber method, a volume of 0.75 ml of the ethanol, MEM or liquid test article was applied to the epithelium of each of the three positive controls, three negative controls, or three test article-treated corneas in a manner, which ensured the entire cornea was covered.
- Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- 2 hours
- Number of animals or in vitro replicates:
- 9 cornea's used in total (3 positive control, 3 negative controls and 3 test article treated)
- Details on study design:
- Pretest Procedures
Fresh assay solutions were prepared prior to use. MEM solution was prepared by stirring together one jar of MEM powder (sufficient to make one liter of solution), 2.2 g Sodium Bicarbonate, 0.292 g L-Glutamine, 10 ml of Fetal Bovine Serum (FBS) and brought to a final volume of 1000 ml with distilled water. The MEM solution was kept in a 32°C (± 1°C) incubator for the duration of testing. Hanks Balanced Salt Solution (HBSS) was prepared by stirring together one jar of HBSS powder (sufficient to make one liter), 0.35 g Sodium Bicarbonate and brought to a final volume of 1000 ml with distilled water. HBSS was maintained at room temperature.
In addition, MEM solution with Phenol Red was prepared by stirring together 9.3 g MEM with Phenol Red (sufficient to make one liter), 2.2 g Sodium Bicarbonate, 0.292 g L-Glutamine, 10 mL Fetal bovine Serum and brought to a final volume of 1000 mL with distilled water. The MEM solution with Phenol Red was kept in a 32°C (± 1°C) incubator for the duration of testing.
The eyes were examined prior to use on the day of dosing. Any eye with a cornea exhibiting evidence of vascularization, pigmentation, opacity or scratches was discarded.
Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The Corneas were then placed in a container of fresh HBSS.
The dissected Corneas were mounted in specially designed holders that were separated into anterior and posterior chambers and filled separately. Each Cornea was mounted allowing the epithelium of the Cornea to project into the anterior chamber. The posterior chamber was filled with MEM solution ensuring contact with the endothelium. The anterior chamber was filled with MEM solution, ensuring contact with the epithelium. Each Cornea was visually inspected again to ensure there were no defects.
The entire holder was incubated at 32°C (± 1°C) and allowed to equilibrate for at least one hour but not longer than two hours.
Following the equilibration period, a pre-exposure (baseline) determination of opacity was made for each cornea by measuring each against the blank supplied with the opacitometer. Any cornea with a value greater than 7 opacity units was discarded.
Study Procedure
Following the pretest observations, the MEM solution was removed from the anterior chamber. Using the closed chamber method, a volume of 0.75 ml of the ethanol, MEM or liquid test article was applied to the epithelium of each of the three positive controls, three negative controls, or three test article-treated corneas in a manner, which ensured the entire cornea was covered.
All holders and corneas were placed in a horizontal position (anterior side up) in the 32°C (± 1°C) incubator. After 10 (± 1) minutes, the test article, ethanol or MEM solution in the controls were removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. Following the 1O-minute (±1 minute) exposure, the corneal epithelium was thoroughly rinsed with MEM solution containing phenol red until the test article, ethanol, or MEM solution (in the negative controls) were washed off. A final rinse was made with MEM without phenol red. The anterior and posterior chambers of the holders were refilled with fresh MEM solution. Opacity measurements were made following the 10-minute exposure and MEM solution refill.
All corneas were incubated at 32°C (± 1°G) for an additional two hours at which time the MEM solution in the anterior and posterior chambers was removed and the holders refilled with fresh MEM solution. A measurement of opacity was taken with each treated cornea compared to the blank supplied with the OPKIT. This reading was used in the final IVIS calculations.
The corneas were visually inspected for abnormalities immediately following the 10-minute exposure period, and again at 2 hours post-exposure. There were no abnormalities noted.
Immediately following the two-hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium. fluorescein solution in Dulbecco's Phosphate Buffered Saline (PBS). Each holder was returned to the 32°C (±1°C) incubator in a horizontal position (anterior side up) ensuring contact of the fluorescein with the cornea.
After 90 (± 5) minutes, the fluid from the posterior chamber was removed and the amount of dye, which passed through the cornea (permeability), was measured as the optical density at 490 nm by a spectrophotometer. A 1: 1000 dilution of the fluorescein was prepared and measured in the spectrophotometer as a measure of consistency.
Analysis of Data
Individual corrected opacity scores were calculated by subtracting the pretest score from the ten minute and two-hour scores. Corrected mean opacity scores were calculated by averaging the individual two-hour corrected opacity scores for a given dose group and subtracting the mean opacity score for the negative control group. A corrected mean opacity score was not calculated for the negative control rather only the mean of the individual two-hour corrected opacity scores were calculated (with no subtraction of mean opacity score for negative control).
Individual corrected optical densities were calculated by subtracting the mean optical density for the negative control group from the individual optical density values. Individual corrected optical densities were not calculated for the negative control group. Corrected mean optical densities were calculated by averaging the individual corrected optical density values for a given dose group. A corrected mean optical density was not calculated for the negative control, rather only the mean of the individual optical densities.
The In Vitro Irritancy Score (IVIS) for the test article and positive control were calculated by adding the corrected mean opacity score to fifteen times the corrected mean optical density as shown by the equation below. The calculations to obtain an IVIS for the positive control was performed in the same manner as the test article.
In Vitro Irritancy Score = Corrected Mean + 15 (Corrected Mean Optical Density Score)
(IVIS) Opacity Score
OECD Guideline #437 defies a substance, which produces an IVIS of >55.1 as Category 1, a substance that causes “Serious eye damage”.
IVIS UN GHS
≤ 3 No Category
>3; ≤55 No prediction can be made
>55 Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- -2.42
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
RESULTS
TEST ARTICLE – H2925 (CAS No. 68130-53-0), Lot# 2013090401
INDIVIDUAL TEST VALUES
CORNEA# |
Pretest Opacity Scores |
10-Minute Scores |
2-Hour Scores |
O.D. ay 490 nm (Permeability) |
7 |
2 |
2 |
2 |
0.028 |
8 |
2 |
2 |
3 |
0.020 |
9 |
1 |
1 |
0 |
0.007 |
INDIVIDUAL AND MEAN CALCULATED VALUES
CORNEA# |
Corrected Opacity Scores |
Individual Corrected O.D.2 |
|
Individual 10-Minute Corrected Opacity Score1 |
Individual 2-Hour Corrected Opacity Score1 |
||
7 |
0 |
0 |
0.004 |
8 |
0 |
1 |
-0.004 |
9 |
0 |
-1 |
-0.017 |
Corrected Mean Opacity Density3= |
-0.006 |
||
2-Hour Corrected Mean Opacity Score4= |
-2.33 |
1Individual Corrected Opacity Score = 10-minute or 2-hour opacity score minus the pretest opacity score
2Individual Corrected Opacity Density = Individual test article OD minus the mean OD for negative control group. No correction was made for the negative control group.
3Corrected Mean Optical Density = Mean of the individual corrected optical density values for a given dose group.
42-Hour Corrected Mean Opacity Score = Mean of the individual 2-hour corrected opacity scores for a given dose group minus the mean opacity score for the negative control group.
NEGATIVE CONTROL – MEM
INDIVIDUAL AND MEAN CALCULATED VALUES
Cornea# |
Pretest Opacity Score |
10-Minute Scores |
10-Minute Corrected Opacity Score1 |
2-Hour Scores |
2-Hour Corrected Opacity Score1 |
O.D. at 490 nm (Permeability) |
C1 (neg) |
2 |
3 |
1 |
4 |
2 |
0.027 |
C2 (neg) |
2 |
3 |
1 |
3 |
1 |
0.027 |
C3 (neg) |
5 |
5 |
0 |
9 |
4 |
0.018 |
Mean of Individual Optical Density = |
0.024 |
|||||
2-Hour Corrected Mean Opacity Score = |
2.33 |
POSITIVE CONTROL – ETHANOL
INDIVIDUAL AND MEAN CALCULATED VALUES
Cornea# |
Individual Pretest Opacity Score |
Individual 10-Minute Scores |
Individual 10-Minute Corrected Opacity Score1 |
Individual 2-Hour Scores |
Individual 2-Hour Corrected Opacity Score1 |
O.D. at 490 nm (Permeability) |
Individual Corrected O.D.2 |
C4 (pos) |
3 |
9 |
6 |
3 |
0 |
0.192 |
0.168 |
C5 (pos) |
3 |
34 |
31 |
34 |
31 |
0.266 |
0.242 |
C6 (pos) |
1 |
32 |
31 |
30 |
29 |
0.175 |
0.151 |
Corrected Mean Optical Density3= |
0.187 |
||||||
2-Hour Corrected Mean Opacity Score4= |
17.67 |
1Individual Corrected Opacity Score = 10-Minute or 2-Hour opacity score minus pretest opacity score.
2Individual Corrected Optical Density = Individual positive control OD minus the mean OD for negative control group.
3Corrected Mean Optical Density = Mean of the individual corrected optical density values for a given dose group.
42-Hour Corrected Mean Opacity Score = Mean of the individual 2-hour corrected opacity scores for a given dose group minus the mean opacity score for the negative control group.
CALCULATED IN VITRO IRRITATION SCORES
Test Article (H2925 (CAS No. 68130-53-0), Lot# 2013090401) -2.33 + 15 (-0.006) -2.33 + (-0.09) IVIS: -2.42 |
Negative Control (MEM) 2.33 + 15 (0.024) 2.33 + 0.36 IVIS: 2.69 |
Positive Control (Ethanol) 17.67 + 15 (0.187) 17.67 + 2.805 IVIS: 20.48 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the In Vitro Irritation Score, H2925 (CAS No. 68130-53-0), Lot# 2013090401, is not classfied as an eye irritant in accordance with the CLP Regulation.
- Executive summary:
Objective: To determine the potential for ocular irritation using an alternative to the Draize methodology.
This protocol is based on the methodology described in the current OECD Guideline for the Testing of Chemicals #437.
Method Synopsis: Three bovine corneas per group were dosed with 0.75 ml of H2925 (CAS No. 6813053-0), Lot# 2013090401, Minimal Essential Media (MEM) (negative control), or 100% Ethanol (positive control). Following a ten-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined.
Summary/Conclusion:
Test Article: The corrected mean opacity score was -2.33. The corrected mean optical density (permeability) score was -0.006. The in vitro irritancy score (IVIS) was calculated as -2.42.
Negative Control: The corrected mean opacity score was 2.33. The mean optical density (permeability) score was 0.024. The IVIS was calculated as 2.69.
Positive Control: The corrected mean opacity score was 17.67. The corrected mean optical density (permeability) score was 0.187. The IVIS was calculated as 20.48.
All controls were within normal limits.
Based on the In Vitro Irritation Score, H2925 (CAS No. 68130-53-0), Lot# 2013090401, is not classfied as an eye irritant in accordance with the CLP Regulation.
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.
Vi har mycket webbmaterial på ditt språk, men en del av den här sidan finns bara på engelska. Mer om vår flerspråkighetspolicy finns.
Välkommen till Echas webbplats. Alla funktioner på den här webbplatsen fungerar inte med Internet Explorer 7 (eller tidigare versioner). Det är därför bäst att du uppgraderar till en nyare version.
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.
Läs mer om hur vi använder kakor.