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EC number: 244-343-6 | CAS number: 21351-39-3
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 14-SEP-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This in vitro study was performed to assess the irritating or corrosive potential of the test item Aduct Urea-Sulfuric by means of the HET-CAM test. The test was carried out with fertilized and incubated chicken eggs. The aim was to evaluate the local irritating effects of Aduct Urea-Sulfuric on mucous membranes or eyes.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Uronium hydrogen sulphate
- EC Number:
- 244-343-6
- EC Name:
- Uronium hydrogen sulphate
- Cas Number:
- 21351-39-3
- Molecular formula:
- CH4N2O.H2O4S
- IUPAC Name:
- hydrogen [amino(hydroxy)methylidene]azanium sulfate
- Details on test material:
- - Name of test material (as cited in study report): Aduct Urea-Sulfuric
- Substance type: monoconstituent substance
- Stability under test conditions: not relevant
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- other: in-vitro test
- Details on test animals or tissues and environmental conditions:
- The HET-CAM test was carried out with Lohmann Selected Leghorn chicken eggs. The Lohmann Selected Leghorn chicken was selected for several reasons: the ability to hatch the eggs of this breed is very consistent and reproducible. There did not appear to be any hereditary defects in this breed.
Test system
- Observation period (in vivo):
- 300 seconds
- Number of animals or in vitro replicates:
- three eggs
- Details on study design:
- In this HET-CAM assay the test item was tested pure. Three eggs were treated with the test item.
Each about 300 μL of the test item were applied directly to the membrane in order to cover at least 50% of the membrane. Each 300 μL of the positive and negative controls were applied to three eggs each. During the observation period for 300 seconds any lesions in close proximity to the covered membrane were monitored and recorded.
The membranes of the eggs were observed for 300 seconds. Lesions of the underlying blood vessels were monitored and noted. In particular three endpoints were observed and the time point at which an effect occurs was recorded. The three endpoints were:
• haemorrhage
• coagulation
• lysis of the blood vessel
Test Groups:
1. Negative Control: saline
2. Positive Control / Sodium dodecyl sulfate: 1% solution in deion. water
3. Positive Control / NaOH: 0.1 N
4. Test Item: pure
Evaluation of results:
CAM Mean Irritancy Index:
0 – 0.9: Not irritant
1 – 4.9: Slight irritant
5 – 8.9: Moderate irritant
9 - 21: Severe irritant
Results and discussion
In vivo
- Irritant / corrosive response data:
- Severe irritating effects were observed during 5 min incubation with Aduct Urea-Sulfuric. The calculated mean irritancy index is 10.27.
The positive controls induced a severe irritation on the blood vessels. The calculated mean irritancy indices are 9.95 for 1% SDS and 18.87 for 0.1 N NaOH.
Any other information on results incl. tables
Table 1: Results with Aduct Urea-Sulfuric, as well as negative and positive control
Test Group |
Time until Haemorrhage [s] |
Time until Lysis [s] |
Time until Coagulation [s] |
Irritancy Index |
Mean Irritancy Index |
Negative Control |
301 |
301 |
301 |
0.00 |
0.00 |
Negative Control |
301 |
301 |
301 |
0.00 |
|
Negative Control |
301 |
301 |
301 |
0.00 |
|
Positive Control 0.1 N NaOH |
9 |
61 |
24 |
18.78 |
18.87 |
Positive Control 0.1 N NaOH |
9 |
50 |
19 |
19.18 |
|
Positive Control 0.1 N NaOH |
10 |
66 |
24 |
18.64 |
|
Positive Control 1% SDS |
18 |
76 |
301 |
9.97 |
9.95 |
Positive Control 1% SDS |
17 |
80 |
301 |
9.89 |
|
Positive Control 1% SDS |
23 |
71 |
301 |
10.00 |
|
Test Item |
16 |
73 |
301 |
10.07 |
10.27 |
Test Item |
12 |
60 |
301 |
10.44 |
|
Test Item |
11 |
67 |
301 |
10.29 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It can be stated that in this study and under the experimental conditions reported, the test item Aduct Urea-Sulfuric (Uronium hydrogen sulphate) possess an irritating potential.
- Executive summary:
This in vitro study was performed to assess the irritating potential of Aduct Urea-Sulfuric (uronium hydrogen sulphate) by detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs (HET-CAM, GLP).
The test item was tested pure.
The observation time was 5 minutes at room temperature.
Physiological sodium chloride solution (0.9% (w/v)) was used as negative control.
The negative control showed no irritating effect on the blood vessels under the membrane.
An 1% solution of SDS and 0.1 N NaOH were used as positive controls.
The positive controls (SDS and NaOH) induced severe irritation on the blood vessels.
Severe irritating effects were observed during 5 min incubation with Aduct Urea-Sulfuric. The calculated mean irritancy index is 10.27. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Aduct Urea-Sulfuric (uronium hydrogen sulphate) possess an irritating potential.
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