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Diss Factsheets
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EC number: 272-379-2 | CAS number: 68815-51-0
- 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:
- 23 Aug 2007- 19 Sep 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ICCVAM: NIH Publication No: 06-4515
- Principles of method if other than guideline:
- There are no official guidelines for the HET-CAM Test; however, the study was conducted according to the following publications:
- Lüpke N.P. (1985): Hen’s Egg Chorioallantoic Membrane Test for Irritation Potential. Fd. Chem. Toxic. 23, pp. 287 – 291.
- Spielmann, H. (1995): HET-CAM Test. In: Methods in Molecular Biology, 43 (eds.:O’Hare, S. and Atterwill, C. K.) pp. 199 – 204.
- Spielmann, H. et al. (1996): Results of a Validation Study in Germany on Two In Vitro Alternatives to the Draize Eye Irritation Test the HET-CAM Test and the 3T3 NRU Cytotoxicity Test. ATLA 24, pp. 741 – 858.
The testing strategy was followed according to OECD Guideline 405. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- EC Number:
- 272-379-2
- EC Name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- Cas Number:
- 68815-51-0
- Molecular formula:
- C18 H34 O2 . C4 H12 N2 O
- IUPAC Name:
- 2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Kerocom F 100; Test-substance No.: 07/0395-1
- Physical state: solid (melt)
- Analytical purity: 100 %
- Purity test date: 18.06.07
- Lot/batch No.: GV33754-L2927
- pH-value: ca. 5 (undiluted test substance)
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.
Constituent 1
Test animals / tissue source
- Species:
- other: hen egg
- Strain:
- other: White Leghorn
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SPAFAS Inc. USA, Charles River Deutschland GmbH, Extertal, Germany
- Weight at study initiation: 56.2 g-57.9 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.5
- Humidity (%): 62.5
- Automatic rotating device: 5 times a day until day 8 and/or day 9 of incubation (inclusively)
Test system
- Vehicle:
- other: olive oil Ph.Eur./DAB
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 ml
- Concentration (if solution): undiluted and 10% in olive oil - Duration of treatment / exposure:
- 3.5 min
- Observation period (in vivo):
- 3.5 min
- Number of animals or in vitro replicates:
- 3 eggs per concentration (undiluted and 10%)
- Details on study design:
- SCORING SYSTEM:
0 No visible change
1 Slight reaction
2 Moderate reaction
3 Severe reaction
Any further findings not covered by this scale were described in the raw data.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Haemorrhagia
- Remarks:
- Mean of grading of effects
- Run / experiment:
- undiluted test substance
- Value:
- 0
- Positive controls validity:
- valid
- Irritation parameter:
- other: Coagulation
- Remarks:
- Mean of grading of effects
- Run / experiment:
- undiluted test substance
- Value:
- 0
- Positive controls validity:
- valid
- Irritation parameter:
- other: Haemorrhagia
- Remarks:
- Mean of grading of effects
- Run / experiment:
- 10% test substance in olive oil
- Value:
- 0
- Positive controls validity:
- valid
- Irritation parameter:
- other: Coagulation
- Remarks:
- Mean of grading of effects
- Run / experiment:
- 10% test substance in olive oil
- Value:
- 0
- Positive controls validity:
- valid
Any other information on results incl. tables
Results observed with the test substance
Concentration |
Egg-No. |
observation period (sec) |
Grading of effects |
Additional findings |
||
Haemorrhagia |
Coagulation |
Haemorrhagia |
Coagulation |
|||
Undiluted test substance |
1 |
210 |
210 |
0 |
0 |
none |
2 |
210 |
210 |
0 |
0 |
none |
|
3 |
210 |
210 |
0 |
0 |
none |
|
Mean |
1-3 |
210 |
210 |
0 |
0 |
none |
Concentration |
Egg-No. |
observation period (sec) |
Grading of effects |
Additional findings |
||
Haemorrhagia |
Coagulation |
Haemorrhagia |
Coagulation |
|||
Test substance 10% in olive oil |
1 |
210 |
210 |
0 |
0 |
none |
2 |
210 |
210 |
0 |
0 |
none |
|
3 |
210 |
210 |
0 |
0 |
none |
|
Mean |
1-3 |
210 |
210 |
0 |
0 |
none |
Positive controls:
Concentration |
Egg-No. |
Time (sec) until appearance of |
Grading of effects |
Additional findings |
||
Haemorrhagia |
Coagulation |
Haemorrhagia |
Coagulation |
|||
0.1 M NaOH |
1 |
18 |
36 |
2 |
2 |
iv |
2 |
20 |
37 |
2 |
2 |
iv |
|
Mean |
1-2 |
19 |
37 |
2 |
2 |
iv: intravascular coagulation
Concentration |
Egg-No. |
Time (sec) until appearance of |
Grading of effects |
Additional findings |
||
Haemorrhagia |
Coagulation |
Haemorrhagia |
Coagulation |
|||
1% SDS |
1 |
39 |
53 |
2 |
2 |
iv,ev |
2 |
38 |
50 |
2 |
2 |
iv, ev |
|
Mean |
1-2 |
39 |
52 |
2 |
2 |
iv: intravascular coagulation
ev: extravascular coagulation
Applicant's summary and conclusion
- Interpretation of results:
- other: No serious eye damage
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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