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EC number: 812-241-6 | 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:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Study performed according to French offical method published in December 1999 in National register N° 302. No deviation has been reported. No Eye irritation classification can be made, only based on this cytotoxic experiment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix VI of the French National Register N°302 of December, 1999
- Principles of method if other than guideline:
- The method is an alternative to animal experimentation, to determine the ocular irritant potential of cosmetic products. The principle is based on assessing the cytotoxicity of the product tested by identifying the concentration causing 50% mortality (IC50) using the technique of neutral red release.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Enzymatic hydrolysis products of Ophiopogon japonicus, Liliaceae, root
- EC Number:
- 812-241-6
- Cas Number:
- 952500-62-8
- IUPAC Name:
- Enzymatic hydrolysis products of Ophiopogon japonicus, Liliaceae, root
- Details on test material:
- Cohesium batch number 07 304 1
slightly yellow liquid
pH 4.5
solution of the test material with phenoxyethanol 0.5% and Ethylhexylglycerin 0.2%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Rabbit cornea fibroblasts: SIRC line (ATCC CCL60)
- Details on test animals or tissues and environmental conditions:
- no animal test
Rabbit cornea fibroblasts: SIRC line from ATCC Cat N°2-552 - CCL60
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Dilution at 5%, 15%, 25%, 35% and 50% of the test material are used.
- Duration of treatment / exposure:
- Cells are exposed 1 minute to the dilution of the test material
- Observation period (in vivo):
- not specified
- Number of animals or in vitro replicates:
- Dilution at 5%, 15%, 25%, 35% were tested in Monoplicate, Dilution 50% was tested in duplicate
- Details on study design:
- Positive and negative control are used.
A suspension at 200,000 cells/ ml complete DMEM medium is prepared 24 hours before the assay is performed.
The day of the experiment, 1 ml of the solution of neutral red at 0.05mg/ml, is deposited on the cells, and placed for 3 hours in the incubator.
Then cells are exposed to a dilution of the test substance for 1 minute. Every dilution is tested one time except the dilution 50% which is tested in duplicate.
After exposure, cells are washed with 1 ml of PBS, and are treated with a revelatory solution (acetic acid/ Ethanol :1/100) .
The optical density of the resulting solution is measured at 540 nm.
The optical density (OD) values obtained for each test chemical are then used to calculate cell viability. The relative cell viability is expressed as a percentage and obtained by dividing the OD of test chemical by the OD of the solvent control.
The following formula is used: % mortality = 100- (OD cells exposed to test mateiral)/ (OD of negative control) X 100.
The curve of per cent cell mortality vs. Concentration of the product is plotted. the IC50 of the test product is obtained by extrapolation from the dose response curve.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Percentage of mortalité observed at the 50% dilution
- Value:
- 31
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- 31% of mortality observed at the 50% dilution
- Irritation parameter:
- other: Estimated IC 50 (%)
- Value:
- > 50
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- The cytotoxicity of tested material is slightly important.
IC 50 is greater to 50% and the percentage of mortality observed at the dilution 50% is 31%
Any other information on results incl. tables
Table 1: Optical density means for the test material and percentage of cells mortality
Optical density (OD) and cells mortality (%) |
||||||
Test material concentration % (p/p) |
0 |
5 |
10 |
25 |
35 |
50 |
OD Well 1 |
1.319 |
1.035 |
0.937 |
0.928 |
0.902 |
0.843 |
OD Well 1 |
1.380 |
1.028 |
0.934 |
0.930 |
0.903 |
0.856 |
OD means Well 1 |
1.350 |
1.032 |
0.936 |
0.929 |
0.903 |
0.850 |
OD Well 2 |
1.059 |
|
|
|
|
0.829 |
OD Well 2 |
1.064 |
|
|
|
|
0.822 |
OD means Well 2 |
1.062 |
|
|
|
|
0.826 |
OD means |
1.206 |
1.032 |
0.936 |
0.929 |
0.903 |
0.838 |
% mortality |
0 |
14 |
22 |
23 |
25 |
31 |
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- table of French national register N°302, December 1999
- Conclusions:
- The test material is considered as slightly irritant considering the fact that the cytotoxicity is not very important according to guideline followed
- Executive summary:
An in vitro eye irritation study was performed, on rabbit cornea fibroblasts, according to French national Method published in December 1999 in National register N° 302.
The principle of the method is based on assessing the cytotoxicity of the product tested by identifying the concentration causing 50% mortality (IC50) using the technique of neutral red release.
The IC50 was up to 50% and the percentage of mortality at the dilution 50% is 31% .
According to the method the cytotoxicity is considered not very important.
The cytotoxicity is slightly important according to guideline followed.
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