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EC number: 810-418-2 | CAS number: 1703784-30-8
- 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:
- 21-12-2018 - 23-01-.2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- February 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- October 2007
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- EC Number:
- 810-418-2
- Cas Number:
- 1703784-30-8
- IUPAC Name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2298695
- Expiration date of the lot/batch: 3 February 2019
Test animals / tissue source
- Species:
- other: Bovine Corneas
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from cattle in the age range of 6 to 12 months were obtained from a slaughterhouse.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Each 0.75 mL of the undiluted test item were applied to three bovine corneas.
- Duration of treatment / exposure:
- The corneas were exposed to the test item solution for 10 minutes.
- Duration of post- treatment incubation (in vitro):
- two hours
- Number of animals or in vitro replicates:
- 3 corneas per group (test item, negative control, positive control)
- Details on study design:
- Three corneas were epxosed to each 0.75 mL of the undiluted test item in physiological saline. After treatment the test item was rinsed off the corneas and they were incubated for further 2 hours. After the 2 hours incubation the cornea's opacity was determined. In a second step the permeability of the corneas was determined phototometrically after 90 minutes treatment with fluorescein solution.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 3.479
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Permeability score
- Value:
- 0.486
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Value:
- 10.769
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results after 10 Minutes Incubation Time:
|
Cornea No. |
Opacity |
Permeability |
IVIS |
||
Per Cornea |
Per Group |
|||||
Mean |
SD |
|||||
0.9% NaCl |
1 |
-0.836 |
0.001 |
-0.821 |
-0.411 |
0.357 |
2 |
-0.319 |
0.010 |
-0.169 |
|||
3 |
-0.319 |
0.005 |
-0.244 |
|||
Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated |
4 |
1.168 |
0.423 |
7.513 |
10.769 |
3.027 |
5 |
4.276 |
0.468 |
11.296 |
|||
6 |
4.993 |
0.567 |
13.498 |
|||
1% NaOH |
7 |
55.829 |
1.819 |
83.114 |
83.027 |
3.781 |
8 |
54.794 |
1.627 |
79.199 |
|||
9 |
64.874 |
1.459 |
86.759 |
SD: Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: no prediction concerning irritant or severely irritant potential of the test item can be made
- Remarks:
- Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Under the present test conditions Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated tested in the in vitro BCOP test method, had an IVIS value of 10.769, which is above the cut-off value of 3 (UN GHS no category) and below the cut-off value of 55, identifying test substances as inducing serious eye damage (UN GHS Category 1). Consequently no prediction concerning irritant or severely irritant potential of the test item can be made.
- Executive summary:
The purpose of this study was to determine the ocular irritancy potential of Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
in an in vitro system. The Bovine Corneal Opacity and Permeability Assay (BCOP) test method is an organotypic model that provides short-term
maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, possible damage by the test item was assessed by quantitative measurements of changes in corneal opacity and permeability in
isolated corneas from bovine eyes.
Three corneas were used for each treatment group (test item, negative control and positive control). The liquid test item Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
was used undiluted as recommended in the test guideline OECD 437. 0.9% NaCl solution was used as the
negative control and 1% NaOH in water (highly purified water) as the positive control item.
The test and control items were applied to the epithelial surface of the cornea by addition to the anterior chamber of the corneal holder. The exposure time for the test item and the controls was 10 minutes. The optical density (OD) was
measured at a wavelength of 490 nm.
The acceptance criteria of validity were fulfilled in this test.
Following treatment with Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
a mean opacity of 3.479 ± 2.033 and a mean permeability value of 0.486 ± 0.074 compared to the negative control were determined. The calculated IVIS of 10.769 ± 3.027 is above the cut-off value of 3
(UN GHS no category) and below the cut-off value of 55, identifying test substances as inducing serious eye damage (UN GHS Category 1). Consequently no prediction concerning irritant or severely irritant potential of the test item can be made.
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