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Diss Factsheets
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EC number: 700-816-3 | CAS number: 9041-08-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Experimental start date : 7 November 2012 - Experimental completion date: 12 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Heparin, sodium salt
- Cas Number:
- 9041-08-1
- IUPAC Name:
- Heparin, sodium salt
- Details on test material:
- Test article identification: Heparin sodium (P10043)
Test article description: Powder
Batch 12PL5716
Storage conditions bulk material: room temperature
Retest or expiry date: 11 june 2005
Constituent 1
Test system
- Details on study design:
- Principle of the test:
The Rhe-based test method measures the initiating events occuring in skin irritation, beginning with penetration of the stratum corneum and damage to the underlying layers of keratinocytes.
It moreover directly covers the initial step of the inflammatory cascade/mechanism of action (cell damage and tissue damage resulting in localized trauma) that occurs during irritation in vivo.
Test description:
The experimental design is based on the assessment of the potential skin irritation induced by the test article applied on three epidermis with comparison with negative and positive controls. The test article, the positive and negative controls are applied topically to each epidermis, depending on the physical form of the test article:
- solid powder: 11+/- 1.5 mg (to be crushed to a fine powder if needed using a mortar and a pestle)
The duration of exposure is approximately 15 minutes. The post-treatment incubation is approximately 42 hours at 37+/-2°C, 5+/-1% CO2. The viability is assessed after approximately a 3-hour incubation with MTT solution in a 12-well plate (0.3 mg/ml; 2ml per well).
Reading of optical density - viability determination
Cell viability in RhE model is measured by enzymatic conversion of the yellow vital dye MTT into blue formazan salt that is quantitatively measured after extraction from tissues. The precipitated formazan is extracted with acidified isopropanol (0.5 ml) and quantified spectrophotometrically at 570 nm +/- 30 nm (200 µl/well). The Mean Optical Density (MOD) is the mean calculated from measurement on 6 wells, with 2 wells per epidermis.
Data evaluation
the relative survival (mean viability in %) of each treated epidermis is determined by comparing the corrected MOD of the 3 wells treated with the test article or positive control to the corrected MOD of the 3 negative control wells.
Experiment acceptance criteria
The experiment is considered valid when the following acceptance criteria are fulfilled:
- mean OD value from the 3 tissues treated with NC should be >= 0.6 and =<1.5;
- mean PC viability expressed as % of NC should be <=40%;
- SD of % viability from NC and PC should be <= 18%
A test article is considered to induce an acceptable response in the skin irritation test when the criteria listed below are fulfilled:
- test article induces the same effect on each epidermis: all individual values for viability should be either <= 50% or all individual values should be >50%
- SD of viability from test article-treated epidermis should be <=18%
Results which only partially satisfy one of the above criteria are dealt on a case by case basis, taking into account the reproducibility and the biological relevance.
When the experiment does not meet the acceptance criteria, additional experiment may be performed.
Positive control: 5 % aqueous sodium dodecyl sulphate (SDS)
Negative control: phosphate buffered saline (D-PBS)
Results and discussion
Any other information on results incl. tables
Mean results for optical density, viability (in%) and standard deviation
Mean OD | Mean viability (%) | Standard deviation OD Viability (%) |
||
Negative control | 0.801 | 100.0 | 0.09 | 10.72 |
Positive control | 0.172 | 21.4 | 0.05 | 6.53 |
Heparin sodium | 0.798 | 99.6 | 0.10 | 13.06 |
With Heparin sodium, the mean viability was higher than 50% which indicated a non-irritant potential.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under these experimental conditions, the test article Heparin sodium was considered as non-irritant to the skin.
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