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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-185-5 | CAS number: 1310-73-2
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- other: Data sharing dispute
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to guideline similar to OECD guideline 435 In Vitro Membrane Barrier Test Method for Skin Corrosion, however the concentration of NaOH tested is not reported (only the volume of the formulation tested is reported)
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of In Vivo (Draize Method) and In Vitro (Corrositex Assay) Dermal Corrosion Values for Selected Industrial Chemicals
- Author:
- Stobbe JL, Drake KD, Maier KJ
- Year:
- 2 003
- Bibliographic source:
- International Journal of Toxicology, 22;99-107
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- yes
- Remarks:
- The concentration of NaOH tested is not reported
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
Constituent 1
In vitro test system
- Test system:
- artificial membrane barrier model
- Source species:
- other: Corrositex assay (in vitro membrane barrier test method for skin corrosion)
- Details on test system:
- Corrositex assay:
- glass vials which contain the chemical detection system covered by a biobarrier membrane disc, it is an amber-colored liquid composed of water and two pH indicator dyes (one basic indicator, phenyl red, and one acidic indicator, methyl orange)
- the biobarrier consists of a cellulose membrane covered with a collagen gel - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): an aliquot (500 µl) of the test material is placed on the biobarrier membrane - Duration of treatment / exposure:
- The time to an observed change in either the color or consistency in the chemical detection system is determined.
- Number of replicates:
- 4 replicate biobarrier membranes and chemical detection system assemblies
Test system
- Details on study design:
- TEST CONDITIONS:
- prior to conducting tests: all formulations were qualified, categorized, and classified:
qualification: direct addition of the test substance to the chemical detection system to verify that the test substance will cause a change in the chemical detection system and is herefore compatible with the Corrositex assay.
categorization: determines the appropriate cut-off times for correct classification of the formulation by adding 150 µl of the test substance to two buffer solutions to categorize the test formulation as acidic (pH 0 to 7) or basic (pH 7 to 14). The color change occurs if the test substance changes either of the two buffer solutions by greater than 1.0 pH units. The resulting color change was compared to the corresponding color charts on the Corrositex testing protocol poster (In Vitro International 1995) classification: to classify the formulations, 500 µl of the selected formulation were placed on each of four replicate biobarrier membranes and chemical detection system assemblies. The start time for each replicate was recorded, and the vials observed unitl a change in the CDS occurred. The breakthrough time was recorded for each of the four replicates. The average time was compared to the packing group assignment table, and the classification (as corrosive or noncorrosive, and packing group assignment) determined and recorded.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Value:
- 13.6
Any other information on results incl. tables
Results of the Corrositex assay (break through time in min):
FCN | Corrositex | Break through | PG (in vitro) | PG (in vivo) | Prediction |
24 | 1 | 13.16 ± 0.06 | II | II | C |
FCN: formulation code number
SD: 1 standard deviation
CL: certified limit
PG: packing group number
C: in vitro correctly predicted
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Remarks:
- 500 µL of a water-based formulation containing sodium hydroxide; breakthrough time of 13.16 min ± 0.06
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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