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EC number: 919-489-5 | 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:
- 2015-05-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile
- EC Number:
- 919-489-5
- Molecular formula:
- C13H23N
- IUPAC Name:
- Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile
1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: abattoir
- Number of corneae: 9
- Characteristics of donor animals: 9 month old
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were transported to the laboratory in HBSS at ambient temperature. The corneae were isolated on the same day after delivery of the eyes.
- Time interval prior to initiating testing: The corneae were directly used in the BCOP test on the same day.
- indication of any existing defects or lesions in ocular tissue samples: Eyes presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.75 mL - Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- After the test item or control items were rinsed off from the application side with saline, the corneae were incubated at 32 ± 1 °C for further two hours in a vertical position, followed by a second opacity reading.
- Number of animals or in vitro replicates:
- 3 corneas were used per group (test item, negative and positive control)
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded. The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. Each isolated cornea was mounted in a specially designed cornea holder that consists of anterior and posterior compartments, which interlace with the epithelial and endothelial sides of the cornea.
QUALITY CHECK OF THE ISOLATED CORNEAS
The basal opacity of all corneae was recorded. Each corneae with a value of the basal opacity > 7 was discarded.
NUMBER OF REPLICATES
Sets of three corneae were used for treatment with the test item and the negative and positive controls.
NEGATIVE CONTROL USED
Saline (0.9% NaCl in deionised water)
POSITIVE CONTROL USED
2-Ethoxyethanol (purity: 99%)
APPLICATION DOSE AND EXPOSURE TIME
0.75 mL of undiluted substance, 10 min exposure time
POST-INCUBATION PERIOD: yes, two hours after rinsing
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: no number determined. The test item was rinsed off.
METHODS FOR MEASURED ENDPOINTS
- Corneal opacity: Changes in the light transmission passing through the corneae were determined using an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) was used.
DECISION CRITERIA:
IVIS ≤ 3: No Category (according to GHS)
IVIS >3 ≤ 55: No prediction can be made
IVIS > 55: Serious eye damage according to CLP/EPA/GHS (Cat 1)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 0.69
- Positive controls validity:
- valid
- Remarks:
- 79.37
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not reported.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 0.69).
- Acceptance criteria met for positive control: Yes. The positive control (2-Ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 79.37)
- Range of historical values if different from the ones specified in the test guideline: Negative control: 0.87 – 1.42; positive control: 56.25 – 80.65
Any other information on results incl. tables
Results after 10 min incubation time
Test group |
Opacity value = Difference (t130-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
Proposed in vitro Irritancy Score |
||
|
|
Mean |
|
Mean |
|
|
|
Negative control |
-1 |
-0.33 |
0.082 |
0.068 |
0.23 |
0.69 |
Not categorized |
0 |
0.065 |
0.98 |
|||||
0 |
0.058 |
0.87 |
|||||
Positive control |
50.33 |
1.348 |
70.55 |
79.37 |
Category 1 |
||
67.33 |
1.395 |
88.25 |
|||||
53.33 |
1.731 |
79.29 |
|||||
Test item |
0.33 |
-0.008 |
0.21 |
0.50 |
Not categorized |
||
0.33 |
-0.013 |
0.13 |
|||||
1.33 |
-0.011 |
1.16 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this in vitro assay, the test substance is considered as not requiring classification for eye irritation or serious eye damage.
- Executive summary:
The in vitro study was performed to assess the corneal damage potential of the test substance by means of the BCOP assay using fresh bovine corneae. The study was conducted according to OECD 437. After a first opacity measurement of the fresh bovine corneae (t0), the neat test item, the positive, and the negative controls were applied to corneae fixed in an incubation chamber in horizontal position for 10 minutes at 32 ± 1 °C. The posterior chamber contained incubation medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae. Further, the corneae were incubated for another 120 minutes at 32 ± 1 °C in a vertical position, while the anterior chamber contain incubation medium as well. Afterwards, opacity was measured a second time (t130). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (0.9 % (w/v) NaCl solution in deionised water) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the test item did not cause an increase of the corneal opacity or permeability. The calculated mean in vitro irritancy score was 0.50. According to OECD 437 the test item is considered as not requiring classification for eye irritation or serious eye damage.
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