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Diss Factsheets
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EC number: 911-915-8 | 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:
- from 2009-09-28 to 2009-11-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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: ICCVAM Test Method Evaluation Report: Appendix G: ICCVAM recommended HET-CAM Method Protocol (Nov. 2006)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Test animals / tissue source
- Species:
- other: not applicable (HET-CAM test in vitro)
- Strain:
- other: not applicable (HET-CAM test in vitro)
- Details on test animals or tissues and environmental conditions:
- Freshly laid Lohmann Leghorn chicken eggs were obtained from the LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany) nine days before the start of the test (arrived on 21. September 2009). Then the eggs were incubated at 38.3 +- 0.2 °C and 58% +- 2% humidity in a still air incubator for eight days. During incubation, the eggs were rotated to prevent an attachment of the embryo to one side of the egg.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable (HET-CAM test in vitro)
- Amount / concentration applied:
- As the test item consists of a wax-like substance, a small amount was weighed into each of six small beakers. The weight of each filled beaker was recorded. For each application, the necessary volume was taken from one of the beakers. The substance was then carefully slid onto the surface of the membrane.
- Duration of treatment / exposure:
- 301 sec
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- 6 eggs (test substance), 3 eggs (negative and positive controls each)
- Details on study design:
- Preparation of Test System
24 hours before the start of the experiment (eight days after obtaining the eggs), the chicken eggs were candled and non-viable eggs were discarded. The rest of the eggs were placed upward in the incubator until the next day.
Experimental Parameters
Date of treatment 30. September 2009
Incubation time 301 seconds
Positive controls Na-dodecylsulphate, 1% NaOH, 0.1 mol/L
Method Description
On the day of the test, the eggs were removed from the incubator for use in the assay.
At first, the eggs were candled and the air bubble was marked. The egg was opened on the air bubble with a rotating dentist’s saw blade. The inner membrane was moistened with 0.9 % NaCl, then the egg was left to stand into the incubator for 30 minutes. After this period, the solution was decanted and the inner membrane was carefully removed with a forceps.
Then the test item was given directly onto the CAM surface.
As the test item consists of a wax-like substance, a small amount was weighed into each of six small beakers. The weight of each filled beaker was recorded. For each application, the necessary volume was taken from one of the beakers. The substance was then carefully slid onto the surface of the membrane.
The test item was given on the membrane in such a manner that 50% of the surface of the membrane was covered with test item.
The reactions on the CAM were observed over a period of 301 seconds. Note: The observation period was chosen as 301 seconds (instead of 300 seconds as recommended by the guideline) due to mathematical reasons in case no reactions on the CAM are observed at all.
The following endpoints are described in the guideline:
- haemorrhage (bleeding from the vessels)
- vascular lysis (blood vessel disintegration)
- coagulation (intra- and extra-vascular protein denaturation)
The time for the appearance of each of the noted endpoints was monitored and recorded in seconds.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean value
- Value:
- 17.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: For details please refer to "Any other information on results incl. tables"
- Other effects / acceptance of results:
- In the negative control, no signs of irritation were observed.
Both positive controls showed severe irritation.
The test item Olaflur showed severe irritation.
Any other information on results incl. tables
Table 1: Irritation Score
Test Group |
Irritation Score |
Mean Irritation Score |
Negative Control |
0.00 |
0.00 |
Negative Control |
0.00 |
|
Negative Control |
0.00 |
|
Positive Control 0.1-N NaOH |
19.97 |
19.87 |
Positive Control 0.1-N NaOH |
19.73 |
|
Positive Control 0.1-N NaOH |
19.91 |
|
Positive Control 1% SDS |
10.64 |
10.55 |
Positive Control 1% SDS |
10.54 |
|
Positive Control 1% SDS |
10.46 |
|
Olaflur |
16.61 |
17.20 |
Olaflur |
17.46 |
|
Olaflur |
17.31 |
|
Olaflur |
17.28 |
|
Olaflur |
17.35 |
|
Olaflur |
17.22 |
Applicant's summary and conclusion
- Interpretation of results:
- other: severe irritation
- Remarks:
- Criteria used for interpretation of results: other: based on ICCVAM recommendation
- Conclusions:
- The test item Olaflur showed severe irritation in HET-CAM test.
- Executive summary:
For this HET-CAM test, hen’s eggs with an age of nine days were used. The test item Olaflur was brought onto the surface of the CAM of a hen’s egg which had been incubated at 38.3°C and 58% humidity for nine days. Observation time was 5 minutes at room temperature.
Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the blood vessels under the membrane.
Solutions of SDS (1%) and NaOH (0.1N) were used as positive controls. The positive controls induced a severe irritation on the blood vessels.
The test item Olaflur showed severe effects on the blood vessels of the CAM. The calculated mean irritation score is 17.20.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Olaflur possesses severe irritation potential.
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