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EC number: 915-318-3 | CAS number: -
- 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:
- 05 September 2017 - 03 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- EC Number:
- 915-318-3
- Cas Number:
- 41199-19-3, 17283-81-7 and 31499-72-6
- IUPAC Name:
- Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- Test material form:
- liquid
Constituent 1
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.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
NEGATIVE CONTROL: Physiological saline
- Amount applied: 750 µL
POSITIVE CONTROL: Ethanol
- Amount applied: 750 µL - Duration of treatment / exposure:
- 10 ± 1 minutes (both experiments)
- Duration of post- treatment incubation (in vitro):
- 120 ±10 minutes in cMEM for opacity measurements and subsequently 90 ±5 minutes in sodium-fluorescein for permeability determinations
- Number of animals or in vitro replicates:
- 3 for the negative control, the positive control and the treatment group each for both experiments.
- Details on study design:
- The experiment was repeated based on a calculation error data. The performed repeat experiment was considered not necessary afterwards. However, the performance of an additional experiment has no impact on the study.
TREATMENT METHOD: The medium from the anterior compartment was removed and 750 µL of either the negative control, positive control or the test item was introduced onto the epithelium of the cornea. The holders were 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 10 ± 1 minutes at 32.0 ± 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 with MEM with phenol red (Earle’s Minimum Essential Medium, Life Technologies) and thereafter with cMEM.
- POST-EXPOSURE INCUBATION: 120 ±10 minutes in cMEM for opacity measurements and subsequently 90 ±5 minutes 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.
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.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- First experiment; mean of 3 replicates
- Value:
- 11
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean IVIS: 55
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Second experiment; mean of 3 replicates
- Value:
- 5.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean IVIS: 57
- Other effects / acceptance of results:
- - 5 out of the 6 individual corneas resulted in an IVIS > 3 ≤ 55
- The corneas treated with the test item showed opacity values between 3.6 and 9.0 in the first experiment and between 0.4 and 2.6 in the second experiment.
- Permeability values were ranging from 0.108 to 0.726 in the first experiment and ranging from 0.070 to 0.670 in the second experiment.
- IVIS scores were 5.2, 9.3 and 20 (n=3) in the first experiment and 3.6, 10 and 2.2 (n=3) in the second experiment.
OTHER EFFECTS:
- No pH effect of the test item was observed on the rinsing medium in both experiments.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within historical range (IVIS ranging from 1.0 to 1.6 in the first experiment and ranging from 0.2 to 0.7 in the second experiment).
- Acceptance criteria met for positive control: yes, results were within historical range (IVIS ranging from 34 to 73 in the first experiment and ranging from 55 to 59 in the second experiment). Corneas were turbid after 10 minutes of treatment in both experiments.
Any other information on results incl. tables
Table 2 Summary of opacity, permeability and in vitro scores in the first experiment
Treatment |
Mean opacity* |
Mean permeability* |
Mean IVIS*# |
Negative control |
1.2 |
0.013 |
1.4 |
Positive control |
18 |
2.463 |
55 |
Test item |
6.3 |
0.326 |
11 |
*Calculated using the negative control
mean opacity and mean permeability values for the positive control and
test item.
#In vitro irritancy score (IVIS) = mean opacity value + (15 x
mean OD490 value).
Table 3 Summary of opacity, permeability and in vitro scores in the repeated experiment
Treatment |
Mean opacity* |
Mean permeability* |
Mean IVIS*# |
Negative control |
0.4 |
0.002 |
0.4 |
Positive control |
22 |
2.299 |
57 |
Test item |
1.2 |
0.282 |
5.4 |
*Calculated using the negative control
mean opacity and mean permeability values for the positive control and
test item.
#In vitro irritancy score (IVIS) = mean opacity value + (15 x
mean OD490 value).
Table 4 Historical Control Data for the BCOP Studies
|
Negative control |
Positive control |
||
|
Opacity |
Permeability |
In vitro Irritancy Score |
In vitro Irritancy Score |
Range |
-2.9 – 3.0 |
-0.016 – 0.042 |
-2.8 – 3.0 |
34.7 - 78.2 |
Mean |
0.08 |
0.01 |
0.17 |
56.01 |
SD |
1.04 |
0.01 |
1.14 |
12.51 |
n |
84 |
77 |
78 |
55 |
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 Aug 2014 to Aug 2017.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the outcome of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline 437 and GLP principles, no prediction on the classification of Polyambrol can be made (IVIS > 3 ≤ 55).
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