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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to validation study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HET-CAM Test
- Principles of method if other than guideline:
- This study was conducted according to the procedures indicated by the following internationally accepted guideline and recomendation:
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:
- no
- Amount / concentration applied:
- For each replicate about 100 mg of the test item were applied directly to the chorioallantoic membrane in order to cover at least 50% of the membrane. 300 μL of each of the positive controls (SDS: 1% solution in deion. water and NaOH: 0.1 N) and the negative control (physiological sodium chloride solution (0.9% (w/v))) were applied to three eggs each.
- Duration of treatment / exposure:
- 300 s
- Observation period (in vivo):
- 300 s
- Number of animals or in vitro replicates:
- 0
- Details on study design:
- CAM Preparation
On day 9, the day of the performance of the experiment, the eggs were candled once again in order to determine the position of the egg's oxygen bubble. The position was marked on the eggshell. Along the marking the eggshell was sawed with an electric saw. Afterwards, the shell above the oxygen bubble was removed. The egg skin beneath was covered with 0.9% (w/v) NaCl in deion. water (saline, produced in-house) in order to separate the egg skin from the chorioallantoic membrane beneath the skin. After 3 minutes incubation at 37.5 ± 0.5 °C the egg skin was removed from the membrane using forceps.
Treatment
In this HET-CAM assay the test item was tested pure. Six eggs were treated with the test item. For each replicate about 100 mg of the test item were applied directly to the membrane in order to cover at least 50% of the membrane. 300 μL of each of the positive controls and the negative control were applied to three eggs each. During the observation period of 300 seconds any lesions in close proximity to the covered membrane were monitored and recorded.
Observations
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
Results and discussion
In vitro
Results
- Irritation parameter:
- other: HET-CAM: Mean Irritancy Index
- Value:
- 0
- 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
Mean irritancy index of 6 eggs: Test item = 0.0
Mean irritancy index of 3 eggs:
Positive control (SDS) = 9.92
Positive Control (NaOH) = 19.12
Negative control = 0.00
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: INVITTOX
- Conclusions:
- Classification: not irritating
- Executive summary:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item SAT 080003 does not possess any irritating potential.
This in vitro study was performed to assess the irritating potential of SAT 080003 by detection of damages in blood vessels under the chorioallantoic membrane of chicken eggs incubated for 9 days (Hen's Egg Test - Chorioallantoic Membrane Test, HET - CAM)
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 (mean irritancy index 0.00).
1 % solutions of sodium dodecyl sulphate (SDS) and 0.1 N sodium hydroxide (NaOH) were used as positive controls.
The positive controls induced severe irritation on the blood vessels (mean irritancy indices of 9.92 for SDS and 19.12 for NaOH)
The mean irritancy indices of the controls are well comparable with the historical control values and are the acceptance criteria. Therefore, it was concluded that the test valid.
No irritating effects were observed during 5 min incubation with the test substance SAT 080003. The calculated mean irritancy 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.
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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