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Diss Factsheets
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Reaction mass of sodium amino-bis{[4-(ethenylsubstituted)phenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-{[4-(ethenylsubstituted)phenyl]diazenyl}-{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-bis{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate
EC number: - | 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
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- 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
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- Nanomaterial aspect ratio / shape
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- Nanomaterial Zeta potential
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- Endpoint summary
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data
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Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- The measurement of the opacity was performed with a photometer (570 nm) instead of an opacitometer. This can be seen as uncritical, because the opacity can be calculated from the absorption. The deviation was signed and assessed by the study director on 07. Aug. 2014.
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- None
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes (Bos primigenius Taurus (Fresh bovine corneas)) were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2 -4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank’s balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 hour.
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 750 μL of the test item were tested as suspension at 20% concentration in 0.9% sodium chloride solution.
- Duration of treatment / exposure:
- Incubation time: 4 hours
- Observation period (in vivo):
- No data
- Number of animals or in vitro replicates:
- No data
- Details on study design:
- Refer to "Any other information on materials and methods incl. tables".
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- -0.29
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- None
- Other effects:
- None
Any other information on results incl. tables
Opacity and Permeability Values
The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Parameter |
Negative Control |
||
Absorption before exposition |
0.1703 |
0.1803 |
0.1790 |
Absorption after exposition |
0.2574 |
0.2851 |
0.5227 |
Opacity before exposition |
1.4801 |
1.5146 |
1.5101 |
Opacity after exposition |
1.8088 |
1.9280 |
3.3320 |
Opacity Difference |
0.3287 |
0.4134 |
1.8219 |
Mean opacity difference of the negative control is 0.8547.
Absorption and Opacity Values Test Item and Positive Control
Parameter |
Test ItemFAT 40865/A TE |
Positive Control |
||||
Absorption before exposition |
0.1908 |
0.2072 |
0.1664 |
0.1583 |
0.1376 |
0.1975 |
Absorption after exposition |
0.2762 |
0.3804 |
0.4183 |
1.7073 |
1.6212 |
1.6112 |
Opacity before exposition |
1.5517 |
1.6114 |
1.4669 |
1.4398 |
1.3728 |
1.5758 |
Opacity |
1.8889 |
2.4010 |
2.6200 |
50.9683 |
41.8023 |
40.8507 |
Opacity |
0.3372 |
0.7897 |
1.1531 |
49.5285 |
40.4295 |
39.2750 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
Repl. |
Negative Control |
Test ItemFAT 40865/A TE |
Positive Control |
||||||
Meas. |
0.0058 |
0.0065 |
0.0051 |
0.0022 |
0.0029 |
0.0045 |
0.3828 |
0.3462 |
0.4711 |
Corr. |
0.0290 |
0.0325 |
0.0255 |
0.0110 |
0.0145 |
0.0225 |
1.9140 |
1.7310 |
2.3555 |
Mean |
0.0290 |
-- |
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.764 |
1.290 |
61.6 % |
0.901 |
|||
2.204 |
|||
Test Item |
- 0.788 |
- 0.290 |
170.4 % |
- 0.283 |
|||
0.201 |
|||
Positive Control |
76.949 |
71.790 |
8.5 % |
65.105 |
|||
73.318 |
Classification
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation
or serious eye damage.
IVIS |
UN GHS Category Eye Damage |
≤ 3 |
No Category |
> 3;≤ 55 |
No prediction can be made |
> 55 |
Eye damage Category I |
In the negative control, no signs of eye irritation were observed. The positive control induced serious eye damage, which would be classified as GHS category 1. The test item FAT 40865/A TE showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is - 0.290
Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean. The negative or solvent control has to show an IVIS between 0 and 3.
The validity criteria and findings are given in the following table:
Parameter |
Criterion |
Found |
Assessment |
IVIS of negative control 0.9% NaCl |
0 - 3 |
1.290 |
ok |
IVIS of positive control |
35.6 – 130.4 |
71.790 |
ok |
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Under the conditions of this test, the test item FAT 40865/A TE showed no effects on the cornea of the bovine eye. Hence, it was considered to be non-irritating to eyes.
- Executive summary:
An OECD 437 guideline study was performed in accordance to GLP to assess the irritation potential of test item FAT 40865/A to eyes using bovine corneas. They were collected from slaughtered cattle which were between 12 and 60 months old. The test item FAT 40865/A TE was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea. 20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea. The calculated IVIS (in vitro irritancy score) was - 0.290. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS≤3 requires no classification for eye irritation or serious eye damage. Hence, under the conditions of this test system, the test item FAT 40865/A TE showed no effects on the cornea of the bovine eye and considered to be non-irritating to eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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