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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 601-419-7 | CAS number: 1162-60-3
- 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:
- 11 December 2017 - 12 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 9 October 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,8,9,10,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one
- EC Number:
- 608-630-3
- Cas Number:
- 31528-46-8
- Molecular formula:
- C20H24O2
- IUPAC Name:
- (8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,8,9,10,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: Off-white powder
Test item storage: At room temperature
Constituent 1
- Specific details on test material used for the study:
- pH: 6.07-6.62
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: young cattle, obtained from the slaughterhouse Vitelco, 's-Hertogenbosch, The Netherlands.
- Storage, temperature and transport conditions of ocular tissue: eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Subsequently, eyes were collected an transported in physiological saline in a suitable container under cooled conditions.
- The eyes were checked for unacceptable defects and those exhibiting defects were discarded.
- Isolated corneas were stored in a petri dish with cMEM containing 1% (v/v) L-glutamine and 1% (v/v) Fetal Bovine Serum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 320.0 to 339.8 mg
POSITIVE CONTROL
- Amount applied: 750 µL
NEGATIVE CONTROL
- Amount applied: 750 µL - Duration of treatment / exposure:
- 240 ± 10 minutes
- Duration of post- treatment incubation (in vitro):
- 90 ± 5 minutes in sodium-fluorescein for permeability measurements
- Number of animals or in vitro replicates:
- 3 for the negative control, the positive control and the treatment group each.
- Details on study design:
- TREATMENT METHOD: The medium from the anterior compartment was removed and 750 µL of the negative control and the positive control were introduced onto the epithelium of the cornea. The test substance was weighed in a glass tube and applied directly on the corneas in such a way that the cornea was completely covered (320.0 to 339.8 mg). The holder was slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the control or the test item over the entire cornea. Corneas were incubated in a horizontal position for 240 ± 10 minutes at 32 ± 1 °C.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions were removed and the epithelium was washed at least three times with MEM with phenol red (Earle’s Minimum Essential Medium, Life Technologies).
- POST-EXPOSURE INCUBATION: 90 ± 5 minutes at 32±1 °C in sodium-fluorescein for permeability determinations.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity meter (OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (TECAN Infinite® M200 Pro Plate Reader, OD490). OD490 values of less than 1.500 were used in the permeability calculation.
- Other: possible pH effects of the test substance on the corneas were recorded. Each cornea was inspected visually for dissimilar opacity patterns.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA (see table 1):
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≤55, no prediction on irritant potency can be made.
ACCEPTABILITY CRITERIA:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3 replicates
- Value:
- < 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- IVIS: -2.7-2.6
- Positive controls validity:
- valid
- Remarks:
- IVIS: 110-139
- Other effects / acceptance of results:
- - The corneas treated with the test substance showed opacity values between -1.5 and -1.0.
- Permeability values were ranging from 0.003 to 0.036
- IVIS scores were -0.9, -0.9 and -0.8 (n=3), resulting in a mean IVIS of -0.9. Since the IVIS scores were < 3, the substance is considered to be non irritant.
- The corneas were clear after 240 minutes of treatment and no pH effect of the test item was observed on the rinsing medium.
ACCEPTANCE OF RESULTS (see table 2 for historical data):
- Acceptance criteria met for negative control: yes, responses for opacity and permeability were less than the upper limits of the historical data range (IVIS ranging from -2.7 to 2.6).
- Acceptance criteria met for positive control: yes, results were within historical range (IVIS ranging from 110 to 139). Corneas were turbid after 240 minutes of treatment.
Any other information on results incl. tables
Table 2 Historical Control Data for the BCOP Studies
|
Negative control |
Positive control |
||
|
Opacity |
Permeability |
In vitro Irritancy Score |
In vitro Irritancy Score |
Range |
-5.4 – 5.2 |
-0.010 – 0.205 |
-5.3 – 5.3 |
86.5 - 211.4 |
Mean |
0.50 |
0.02 |
0.72 |
135.88 |
SD |
1.83 |
0.02 |
1.89 |
26.52 |
n |
136 |
136 |
136 |
137 |
SD = Standard deviation
n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of Nov 2014 to Nov 2017.
Treatment |
Final Opacity* |
Final OD490* |
In vitroIrritancy Score# |
|
|||
Negative control |
0.1 |
0.010 |
0.8 |
2.5 |
0.009 |
0.5 |
|
-2.5 |
-0.011 |
-0.3 |
|
|
|||
Positive control |
122 |
1.391 |
139 |
137 |
1.807 |
122 |
|
126 |
1.781 |
110 |
|
|
|||
Test item |
-1.5 |
0.036 |
-0.9 |
-1.0 |
0.003 |
-0.9 |
|
-1.3 |
0.034 |
-0.8 |
# In vitro irritancy score (IVIS) = opacity value + (15 x OD490 value).
* Positive control and test item are corrected for the negative control.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified according to Regulation (EC) 1272/2008
- Conclusions:
- Based on the outcome of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline 437 and GLP principles, D6-Noreth is considered to be non-irritant for the eyes. The test item is not classified for eye irritation or serious eye damage according to GHS and according to Regulation (EC) 1272/2008.
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.