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Diss Factsheets
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EC number: 205-503-0 | CAS number: 141-82-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2017
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Malonic acid
- EC Number:
- 205-503-0
- EC Name:
- Malonic acid
- Cas Number:
- 141-82-2
- Molecular formula:
- C3H4O4
- IUPAC Name:
- propanedioic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Batch No: 20160723Purity: 99.5 %
Constituent 1
- Specific details on test material used for the study:
- SupplierSponsor Test Item nameMalonic Acid Supplier CodeNot Applicable Supplier batch/lot number20160723 CAS number141-82-2PurityNot Communicated Expiry DateIndefinite Physical stateWhite crystalline solid Storage ConditionsRoom TemperatureSolubilityN/A neat solid application Administration methodTopical application Concentration testedNeat XCellR8 test item codeOXK0002 Study test item codeTA1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- MatTek’s EpiOcularTM system consists of normal, human-derived keratinocytes which have been cultured to form a stratified, squamous epithelium similar to that found in the cornea. Cultured on specially prepared cell culture inserts using serum-free culture medium, the cells differentiate to form a multi-layered structure with progressively stratified, but not cornified cells which closely parallel the corneal epithelium (for information see www.mattek.com). QC results for the specific lot of models received (Lot# 23777) were checked in-house for MatTek acceptance ranges with the following outcome: Morphology - PASS Tissue viability - PASS Skin barrier function (ET50 value for 0.3% Triton X-100) where ET50 is the time taken for 0.3% Triton X-100 to reduce the viability of the skin model to 50% relative to the negative control) - PASS Sterility testing showed no contamination during long term antibiotic and antimycotic free culture - PASS
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Details on study design:
- The test item was first checked for its potential to for MTT interference and solvent interference (water and isopropanol).Overview of main test procedure:Day 0: On the day of receipt, EpiOcularTM tissues were pre-incubated overnight at 37°C, 5% CO2, 95% relative humidity.Day 1: Exposure to and removal of test and reference items (50 mg of test item or 50μl of reference items for 6h± 15 minutes, followed by a 25 ± 2 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation).Day 2: MTT viability test, readings at 570 nm without reference filter#Data analysis for this study was performed following XCellR8 SOP L0069: “EpiOcularTM Eye Irritation Test (OECD TG492)”, using XCellR8 Form F0068: Data Analysis for EpiOcularTM Eye Irritation Test. This is a Microsoft Excel workbook (validated in-house, February 2015) containing formulae to process the raw data as per OECD TG492/SOP L0069. The final data output is a percentage viability value for EpiOcularTM models exposed to the test item relative to the negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Percentage of viability (relative to negative control)
- Value:
- 3.815
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Viability measurements after 6h (± 15 min) of application and 18h (± 15 min) post-incubation of test and reference items.
Condition Tissue # | Raw data | Blank corrected data | Mean OD % of viability | |||||||||||
aliquot 1 | aliquot 2 | aliquot 1 | aliquot 2 |
| ||||||||||
NC | Tissue 1 | 1.416 | 1.435 | 1.272 | 1.291 | 1.282 | 95.243 | |||||||
| Tissue 2 | 1.389 | 1.507 | 1.245 | 1.363 | 1.304 | 96.916 | |||||||
| Tissue 3 | 1.55 | 1.64 | 1.406 | 1.496 | 1.451 | 107.841 | |||||||
PC | Tissue 1 | 0.537 | 0.546 | 0.393 | 0.402 | 0.398 | 29.543 | |||||||
| Tissue 2 | 0.425 | 0.446 | 0.281 | 0.302 | 0.292 | 21.665 | |||||||
| Tissue 3 | 0.455 | 0.455 | 0.311 | 0.311 | 0.311 | 23.114 | |||||||
TA1 | Tissue 1 | 0.191 | 0.182 | 0.047 | 0.038 | 0.043 | 3.159 | |||||||
| Tissue 2 | 0.187 | 0.199 | 0.043 | 0.055 | 0.049 | 3.642 | |||||||
| Tissue 3 | 0.198 | 0.215 | 0.054 | 0.071 | 0.063 | 4.645 | |||||||
NC: negative control (sterile H2O), PC: Positive control (neat Methyl Acetate), TA1: Malonic Acid.
Mean and SD of viability measurements and of viability percentages after 6h (± 15 min) of application and 18h (± 15 min) post-incubation.
Name | Code | mean of OD | SD of OD | Mean of viability (%) | SD of viability (%) | CV % | Classification |
Sterile water | NC | 1.346 | 0.092 | 100.000 | 6.84 | 6.842 | Non-Irritant |
Methyl Acetate | PC | 0.333 | 0.056 | 24.774 | 4.193 | 16.926 | Irritant |
Malonic Acid | TA1 | 0.051 | 0.010 | 3.815 | 0.758 | 19.874 | Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- A test item is considered to be irritant to the eye (i.e. would require labelling as either GHS 1 or 2) if the eye model viability after exposure and post-treatment incubation is ≤ 60%.The percentage of viability obtained with the test item Malonic Acid was 3.815%, therefore it has to be considered as at least irritant to the eye.The current assay is not intended to differentiate between GHS class 1 and GHS class 2 or R36 and R41 (degree of stromal damage). In view of the low percentage viability, obtained in the test; and in comparison with other short chain dicarboxylic acids for which in vivo data is available, malonic acid should be classified as Eye Damage 1
- Executive summary:
In this study, the eye irritation potential of Malonic Acid was assessed in vitro according to OECD Test 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). After 6h exposure on the surface of EpiOcularTM reconstructed ocular epithelium and 18h post-incubation time, the viability of the tissues was assessed and compared to a negative control. The percentage viability obtained was 3.815 %.
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