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Diss Factsheets
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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
- 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:
- June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to: INVITTOX Protocol No. 47: HET-CAM Test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX Protocol No. 47: HET-CAM Test. http://ecvam-sis.jrc.it
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals / tissue source
- Species:
- other: HET-CAM
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Approx. 100 mg of the neat test item were applied onto the CAM
- Duration of treatment / exposure:
- 5 min
- Details on study design:
- Approx. 100 mg of the neat test item were applied onto the CAM in order to cover at least 50% of the CAM. The CAM was exposed to the test item for 5 minutes. During this 5 minutes reactions on the blood vessels in and under the CAM in close proximity to the test item were monitored. The CAMs of three eggs were treated with the test item. In addition to the test item a negative control (0.9% NaCl w/v)), two positive controls (1% SDS solution in deionised water and 0.1 N NaOH), and a reference item (5% (w/v) Texapon) were tested.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean (5 min. exposure)
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results with Sa 57, as well as negative and positive controls, and the reference item
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 |
301 |
301 |
301 |
0.00 |
||
301 |
301 |
301 |
0.00 |
||
Positive Control 0.1 N NaOH |
10 |
45 |
17 |
19.34 |
19.26 |
9 |
41 |
16 |
19.48 |
||
11 |
57 |
20 |
18.96 |
||
Positive Control 1% SDS |
13 |
30 |
301 |
11.12 |
11.11 |
14 |
28 |
301 |
11.15 |
||
14 |
32 |
301 |
11.06 |
||
Reference Item 5% AS Texpon |
17 |
35 |
301 |
10.94 |
10.78 |
22 |
47 |
301 |
10.58 |
||
20 |
38 |
301 |
10.82 |
||
Test Item |
301 |
301 |
301 |
0.00 |
0.00 |
301 |
301 |
301 |
0.00 |
||
301 |
301 |
301 |
0.00 |
Mean irritancy index of 3 eggs: Test Item = 0.00
Mean irritancy index of 3 eggs: Positive Control (Sodium dodecyl sulphate) = 11.11
Positive Control (Sodium hydroxide solution) = 19.26
Reference Item (Texapon) = 10.78
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- other: INVITTOX Protocol No. 47: HET-CAM Test. http://ecvam-sis.jrc.it
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Sa 57 does not possess any irritating potential.
- Executive summary:
This in vitro study was performed to assess the irritating potential of Sa 57 by detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs.
Each 300 µL of the test item, the positive and the negative controls, and the reference item were applied to three eggs each such that at least 50 % of the membrane was covered. During the observation period for 300 seconds any lesions in close proximity to the covered membrane were monitored and recorded. The observation time was 5 minutes at room temperature.
Physiological sodium chloride solution (0.9 % (w/v) in deionised water) was used as negative control.
The negative control showed no irritating effect on the blood vessels under the membrane. The irritancy mean index is 0.00.
A 1 % solution of SDS and 0.1 NaOH were used as positive controls.
The positive controls induced a severe irritation on the blood vessels. The calculated mean irritancy indices are 11.11 for 1 % SDS and 19.26 for 0.1 N NaOH. The reference itemTexapon ASV Spezial (5 % AS) was chosen because of its known eye irritating properties and induced a severe irritation on the blood vessels. The calculated mean irritancy index is 10.78.
The mean irritancy indices of the controls are well comparable with the historical control values and are within the acceptance criteria. The result of the reference item demonstrated a correct interpretation. Therefore, it was concluded that the test was valid.
No irritating effects were observed during 5 min incubation with Sa 57. The calculated irritancy mean index is 0.00.
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.
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