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EC number: - | CAS number: 1309389-73-8
- 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:
- 2016-03-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 2013-07-26
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2015-09-14
Test material
- Reference substance name:
- (2E)-3-(2H-1,3-benzodioxol-5-yl)-N,N-diphenylprop-2-enamide
- Cas Number:
- 1309389-73-8
- Molecular formula:
- C22H17NO3
- IUPAC Name:
- (2E)-3-(2H-1,3-benzodioxol-5-yl)-N,N-diphenylprop-2-enamide
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- Not applicable - Since this is an in vitro study there is no information on test animals.
Test system
- Vehicle:
- physiological saline
- Controls:
- other: Control (saline) bovine corneae were used.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.75 mL of the prepared stock (test item as 20 % suspension (w/v) in vehicle)
(Note: the test item was crushed in mortar with a pistil to improve its consistency. The test item could not be suspended or solved homogeneously, therefore, the prepared stock was distributed to each cornea. Thereby it was taken care of that the corneae were evenly covered with the test item.) - Duration of treatment / exposure:
- 240 minutes
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- Number of bovine corneae per dose:
Test item: triplicates
Negative control: triplicates
Positive control: triplicates - Details on study design:
- COLLECTION OF BOVINE EYES
- isolated bovine eyes of at least 9 month old donor cattle were collected from the abattoir and were transported in Hank's buffered salt solution (HBSS) supplemented with streptomycin / penicillin at ambient temperature.
PREPARATION OF CORNEAE
- all eyes were carefully examined macroscopically for defects.
- the cornea was carefully removed from the eye.
- each cornea was mounted in a specially designed cornea holder according to the description given in OEDC guideline 437 which consists of anterior and posterior compartments, which interface with the epithelial and endothelial sides of the cornea, respectively. Both compartments of the holder were filled with incubation medium.
- for equilibration, the corneae in the holder were incubated in a vertical position for about one hour at 32 ± 1 °C in a water-bath.
- at the end of the incubation period, the basal opacity was determined (t0) of all corneae.
- each corneae with a value of the basal opacity > 7 was discarded.
EXPOSURE OF THE TEST GROUPS TO THE CORNEAE
- the anterior compartment received the test item suspension or negative control (saline) or positive control (10 % (w/v) benzalkonium chloride in saline) at a volume of 0.75 mL each on the surface of the corneae.
- the corneae were incubated in a horizontal position at 32 ± 1 °C in the water-bath (incubation time: 240 minutes).
- the test item, positive control and negatice control were tested in triplicate.
- the test item or control items were rinsed off with saline.
- fresh incubation medium was added into the anterior compartment and opacity was measured (t240)
- permeability of the corneae was determined.
PERMEABILITY MEASUREMENT
- after the final opacity measurement, the incubation medium was removed from the anterior compartment and replaced by 0.5 % (w/v) sodium fluorescein solution in HBSS.
- corneae were incubated in a horizontal position for 90 ± 10 minutes in a water-bath at 32 ± 1 °C.
- incubation medium from the posterior compartment was removed, well mixed and the optical density at 490 nm was determined with a spectrophotometer.
- optical density was measured with a microplate reader (Versamax® Molecular Devices) at 490 nm.
- absorbance values were determined using the software SoftMax Pro Enterprise (version 4.7.1).
EVALUATION OF RESULTS
- Opacity: the change of opacity value of each treated cornea or positive and negative control corneae is calculated by subtracting the initial basal opacity from the post treatment opacity reading (t240 – t0), for each individual cornea.
The average change in opacity of the negative control corneae is calculated and this value is subtracted from the change in opacity of each treated cornea or positive control to obtain a corrected opacity.
- Permeability: the corrected OD490 value of each cornea treated with positive control and test item is calculated by subtracting the average negative control cornea value from the original permeability value for each cornea.
IN VITRO IRRITATION SCORE CALCULATION
The following formula was used to determine the in vitro irritation score (IVIS) of the negative control:
In vitro Irritation Score = opacity value + (15 x OD490 value)
The following formula was used to determine the in vitro irritation score of the positive control and the test item:
In vitro Irritation Score = (opacity value – opacity value mean negative control) + (15 x corrected OD490 value)
The mean IVIS value of each treated group was calculated from the IVIS values.
Depending on the score obtained, the test item was classified into the category according to OECD 437 (please refer to table 1 in the field "Any other information on materials and methods incl. tables" below).
CRITERIA FOR DETERMINATION OF A VALID TEST
The test was acceptable if
- the positive control gives an IVIS that falls within two standard deviations of the current historical mean (updated every three months), and if
- the negative control responses result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1 (mean of 3 replicate eyes)
- Value:
- 2.62
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1: Results after 240 minutes incubation time
Test group |
Opacity value = Difference (t240 – t0) of opacity |
Permeability at 490 nm (OD490) |
In vitro irritancy score |
Mean in vitro irritancy score |
||
|
|
Mean |
|
Mean |
|
|
Negative control |
1 |
0.33 |
0.087 |
0.087 |
2.31 |
1.64 |
0 |
0.087 |
1.31 |
||||
0 |
0.088 |
1.32 |
||||
Positive control |
119.67* |
0.033* |
120.16 |
122.16 |
||
133.67* |
0.036* |
134.20 |
||||
110.67* |
0.097* |
112.12 |
||||
Test item |
3.67* |
0.034* |
4.17 |
2.62 |
||
-0.33* |
-0.006* |
-0.43 |
||||
2.67* |
0.096* |
4.10 |
* corrected values
- with the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 1.64).
- the positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae (mean IVIS = 122.16) corresponding to a classification as serious eye damaging (CLP (Cat 1)).
Table 2: Historical data
|
Positive Control |
Negative Control |
Mean IVIS |
116.58 |
1.38 |
Standard Deviation IVIS |
9.22 |
0.35 |
Range of IVIS |
98.49 – 128.43 |
0.88 – 2.04 |
Mean Opacity t240min |
114.03 |
0.20 |
Standard Deviation Opacity t240min |
13.16 |
0.26 |
Range of Opacity t240min |
91.67 – 159.00 |
0.00 – 0.67 |
Mean Permeability |
0.196 |
0.130 |
Standard Deviation Permeability |
0.323 |
0.187 |
Range of Permeability |
0.000 – 1.438 |
0.055 – 0.750 |
Values of 21 studies with solid test items performed from February 2015 (calendar week 7) until January 2016 (calendar week 3)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vitro eye irritation study according to OECD guideline 437, the substance did not cause an increase of the corneal opacity or permeability. In conclusion, according to the current study and under the experimental conditions reported, the substance is not irritating to the eye (the calculated IVIS = 2.62). A substance with an in vitro irritation score ≤ 3 does not require classification for eye irritation and serious eye damage according to OECD 437 (2013). According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not irritating to the eye.
- Executive summary:
In this in vitro study the substance was tested for its eye irritation potential according to the OECD guideline 437 (2013) using fresh bovine corneae. Three corneae were exposed to either the test item as 20 % suspension (w/v) (0.75 mL), the positive control ( 10% (w/v) Benzalkonium chloride in 0.9% (w/v) NaCl (saline)); 0.75 mL), or the negative control (saline; 0.75 mL) for 240 minutes (incubation temperature: 32 ± 1 °C). After the incubation phase the substance, the positive control, and the negative control were each rinsed from the corneae. Next, the corneal opacity and permeability were measured and the In vitro Irritancy Score (IVIS) was calculated for the test item and the controls.
Relative to the negative control, the substance did not cause an increase of the corneal opacity or permeability.
The calculated mean IVIS was 2.62 (threshold for serious eye damage: IVIS≥ 55). According to OECD 437 (2013) a chemical that induces an IVIS ≤ 3 is considered as not requiring classification for eye irritation or serious eye damage. According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not irritating to the eye.
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