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EC number: 209-506-8 | CAS number: 583-52-8
- 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:
- weight of evidence
- Study period:
- 28 Nov - 16 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted in 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz
Test material
- Reference substance name:
- Diammonium oxalate hydrate
- Cas Number:
- 6009-70-7
- Molecular formula:
- C2H8N2O4.H2O
- IUPAC Name:
- Diammonium oxalate hydrate
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: EpiOcular™
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 mg - Duration of treatment / exposure:
- 6 h
- Duration of post- treatment incubation (in vitro):
- 18 h
- Number of animals or in vitro replicates:
- in duplicates for each treatment and control group
- Details on study design:
- - RhCE tissue construct used, including batch number: EpiOcular™ tissue (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia), batch number: 23757
- Viability: The quality of the final tissue was assessed by undertaking an MTT cell viability test.
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 μL of 0.3% Triton X-100. The ET-50 value was determined to be 20.43 min.
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals: The ability of the test substance to directly reduce MTT and to form a blue/purple reaction product was assessed in a preexperiment. Since the MTT solution colour did not turn blue/purple, the test substance is not presumed to have reduced the MTT. An additional test with freeze-killed tissues did not have to be performed.
- Number of tissue replicates used per test chemical and controls: 2
- Wavelength: 570 nm
- Evaluation criteria: The test substance is considered to be not irritating to eye if the test substance-treated tissue viability is >60%.
- Acceptance criteria: The results are acceptable if the negative control OD is >0.8 and <2.5, if the mean relative viability of the positive control is below 50% of the negative control viability and if the difference of viability between the two relating tissues of a single test item is < 20% in the same run (for positive and negative control tissues and tissues of test items).
- Reference to historical data of the RhCE tissue construct: Historical control data was used to assess the validity of the test.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % tissue viability mean value of 2 tissues
- Run / experiment:
- 6 h exposure
- Value:
- 3.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER OBSERVATIONS:
The optical pre-experiment (colour interference pre-experiment) to investigate the colour change potential of the test substance in water or isopropanol did not lead to a change in colour. Optical evaluation of the MTT-reducing capacity of the test substance with MTT-reagent did not show blue colour.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control OD values between 1.361 and 1.417 was in the range of > 0.8 and < 2.5.
- Acceptance criteria met for positive control: Treatment with the positive control induced a decrease in the mean relative absorbance compared with the negative control to 18.2%, thus the validity of the test system is ensured.
The difference of viability between the two relating tissues of a single substance is < 20% (values between 1.3% to 4.6%) in the same run (for positive and negative control tissues and tissues of single test substance).
Any other information on results incl. tables
Table 1: Results after treatmen for 6 h with the test substance and the controls
Dose Group | Absorbance Well 1 (Tissue 1/2) | Absorbance Well 2 (Tissue 1/2) | Mean Absorbance (Tissue 1/2) | Mean Absorbance* Tissue 1 and 2 minus Mean Blank | Mean Absorbance of 2 Tissues* | Rel. Absorbance [%] Tissue 1 and 2** | Difference of the Rel. Absorbances [%] Tissue 1 and 2 | Viability [% of Negative Control]** |
Blank | 0.038 | 0.038 | 0.038 | 0.000 | ||||
Negative Control | 1.384 | 1.361 | 1.373 | 1.335 | 1.355 | 98.5 | 3.0 | 100.0 |
1.417 | 1.410 | 1.414 | 1.376 | 101.5 | ||||
Positive Control | 0.249 | 0.258 | 0.253 | 0.215 | 0.247 | 15.9 | 4.6 | 18.2 |
0.318 | 0.314 | 0.316 | 0.278 | 20.5 | ||||
Test substance | 0.072 | 0.072 | 0.072 | 0.034 | 0.042 | 2.5 | 1.3 | 3.1 |
0.089 | 0.089 | 0.089 | 0.051 | 3.8 |
Table 2 Historical Control Data
Positive Control | Negative Control [OD570] | ||
Mean Viability | 32.47% | Mean Absorption | 1.49 |
Rel. Standard Deviation | 10.29% | Rel. Standard Deviation | 0.24 |
Range of Viabilities | 15.90% - 42.30% | Range of Absorbance | 1.24 - 2.05 |
Mean Absorption | 0.48 | ||
Rel. Standard Deviation | 0.14 | ||
Range of Absorbance | 0.22- 0.64 |
Applicant's summary and conclusion
- Interpretation of results:
- other: the results of this study as a stand-alone study are not suitable for classification according to CLP/EU GHS criteria; the results may be used for classification purposes in a weight of evidence approach
- Conclusions:
- Under the conditions of the conducted EpiOcular test, the test substance showed irritating properties towards human-derived epidermal keratinocytes in the EpiOcular™ model.
Based on the weight of evidence approach in consideration of the results of the BCOP Assay (please refer to reference 7.3.2-2) and the Epiocular test (reference 7.3.2-1), the test substance meet the classification criteria as eye irritant according to Regulation(EC) No. 1272/2008.
CLP: Eye Irrit. Cat. 2, H319
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