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EC number: 244-449-2 | CAS number: 21573-31-9
- 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:
- 2017-08-09
- 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)
- Version / remarks:
- 2013
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Oct-7-enal
- EC Number:
- 244-449-2
- EC Name:
- Oct-7-enal
- Cas Number:
- 21573-31-9
- Molecular formula:
- C8H14O
- IUPAC Name:
- oct-7-enal
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Chemical name: Oct-7-enal (OEL)
- CAS no.: 21573-31-9
- EC-no.: not assigned
- Source and lot/batch No.of test material: Kuraray / 82725
- Expiration date of the lot/batch: 24 April 2018
- Molecular weight: 126.198 g/mol
- Purity: 95.4%
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 750 uL
- Concentration (if solution): as recieved
VEHICLE
- Amount applied (volume or weight with unit): 750 uL
- Concentration (if solution): 0.9% NaCl - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 10 minutes
- Number of animals or in vitro replicates:
- 3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive controls treated with ethanol 100% - Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS
NUMBER OF REPLICATES: 3 corneas/dose
NEGATIVE CONTROL USED: yes, physiological saline 0.9% NaCl
POSITIVE CONTROL USED: yes, ethanol 100%
APPLICATION DOSE AND EXPOSURE TIME: Single 750 uL application for 10 minutes at 32°C
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: washed three times with Minimum essential medium (MEM) with phenol red (used for the rinsing of test substances only). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red).
- POST-EXPOSURE INCUBATION: 2 hours.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer
- Corneal permeability: 1 mL of a 4 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer (Jenway 6405 UV/VIS).
- Others (e.g, pertinent visual observations, histopathology): each cornea was observed visually and pertinent observations were recorded
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The IVIS cut-off values for identifying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given below:
IVIS UN GHS
= 3 No Category
> 3; = 55 No prediction can be made
> 55 Category 1
An identification of test substances that should be classified as irritating to eyes (UN GHS Category 2 or Category 2A) or test substances that should be classified as mildly irritating to eyes (UN GHS Category 2B) cannot be made
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 59.17
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
- Acceptance criteria met for positive control:
Any other information on results incl. tables
Individual Data
Table CA 7.3.2/02-1:Opacity
Test item |
Cornea no. |
Initial opacity |
Final opacity |
Change of opacity value |
Corrected opacity value |
Negative control |
1 |
1.65 |
1.08 |
-0.57 |
n/a |
2 |
1.65 |
1.54 |
-0.11 |
||
3 |
1.58 |
1.04 |
-0.53 |
||
Mean |
1.63 |
1.22 |
-0.40 |
||
Test item |
1 |
0.02 |
13.12 |
13.10 |
13.51 |
2 |
1.15 |
13.24 |
12.09 |
12.49 |
|
3 |
2.54 |
16.72 |
14.19 |
14.59 |
|
Mean |
1.23 |
14.36 |
13.13 |
13.53 |
|
Positive control (ethanol, 100%) |
1 |
3.11 |
40.60 |
37.49 |
37.90 |
2 |
2.88 |
30.21 |
27.34 |
27.74 |
|
3 |
3.03 |
33.25 |
30.22 |
30.62 |
|
Mean |
3.01 |
34369 |
31.68 |
32.09 |
Table CA 7.3.2/02-2: Permeability
Test item |
Cornea no. |
OD490 |
Corrected OD490 value |
Negative control |
1 |
0.009 |
n/a |
2 |
0.013 |
||
3 |
0.004 |
||
Mean |
0.009 |
||
Test item |
1 |
2.645 |
2.636 |
2 |
2.995 |
2.986 |
|
3 |
3.515 |
3.506 |
|
Mean |
3.052 |
3.043 |
|
Positive control (ethanol, 100%) |
1 |
1.1013 |
1.004 |
2 |
1.147 |
1.138 |
|
3 |
2.120 |
2.111 |
|
Mean |
1.427 |
1.418 |
Table CA 7.3.2/02-3: In Vitro Irritation Score
Test item |
Cornea no. |
Corrected opacity |
Corrected OD490 value |
IVIS |
Negative control |
1 |
-0.57 |
0.009 |
-0.27 |
2 |
-0.11 |
0.013 |
||
3 |
-0.53 |
0.004 |
||
Mean |
-0.40 |
0.009 |
||
Test item |
1 |
13.51 |
2.636 |
59.17 |
2 |
12.49 |
2.986 |
||
3 |
14.59 |
3.506 |
||
Mean |
13.53 |
3.043 |
||
Positive control (ethanol, 100%) |
1 |
37.90 |
1.004 |
53.36 |
2 |
27.74 |
1.138 |
||
3 |
30.62 |
2.111 |
||
Mean |
32.09 |
1.418 |
Table CA 7.3.2/02-4: Historical Mean In Vitro Irritation Score of the Positive Control
|
IVIS positive control – ethanol 100% |
Mean value: |
48.47 |
Standard deviation (SD): |
10.08 |
Mean value - 2 SD: |
28.31 |
Mean value + 2 SD: |
68.64 |
No. of replicates providing historical mean: 43 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of this study the Oct-7-enal showed irreversible effects on the eye using the BCOP permeability assay. The mean in vitro irritancy score (IVIS) was 59.17 after a 10 minute exposure (+ 2 hour post-incubation). Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, Oct-7-enal is classified as Category 1: Irreversible effects on the eye, H318: Causes serious eye damage.
- Executive summary:
The BCOP test method was used to identify if Oct-7-enal induced serious eye damage as defined by UN GHS, i.e. chemicals to be classified as UN GHS Category. In the present study Oct-7-enal was applied topically to the isolated bovine corneas for 10 minutes followed by a 2 hour post-incubation period. Negative (0.9% NaCl) and positive controls (ethanol, 100% were included). Irritant potential of the test article was predicted using an opacitometer to assess corneal opacity, with corneal permeability assessed with the sodium fluorescein solution, with optical density at 490 nm ready using a spectrophotometer. These values were corrected for background opacity and the negative control permeability. The mean opacity and permeability OD490 values for each treatment group were combined in an empirically-derived formula to calculate an in vitro irritancy score (IVIS) for each treatment group. An IVIS score of 53.36 was obtained for the positive control (ethanol, 100%), thereby confirming that serious eye damage could be detected in this test system. The test item induced slight opacity, with an IVIS scored of 59.17 calculated after a 10 minute exposure (+ 2 hour post-incubation). Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, Oct-7-enal is classified as Category 1: Irreversible effects on the eye, H318: Causes serious eye damage.
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