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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
Endpoint summary
Administrative data
Description of key information
Malonic acid was mildly irritating in an in vivo study in rats, but not sufficient for classification under EU CLP.
In an in vitro eye irritation test, malonic acid was considered to be irritating. Although the test is not able to distinguish between category 1 and category 2 eye damage or irritation, in view of the low cell viability, and the low pH of this substance, it has been classified as Eye Damage Category 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study was conducted prior to GLP and OECD guideline implementation
- Qualifier:
- according to guideline
- Guideline:
- other: US DOT (Transport-Classification) Guidelines
- Principles of method if other than guideline:
- The study was performed before GLP- and OECD-testing guidelines were available and in force. The intact and abraded skin of 120 albino rabbits was employed for this study. A series of 6 rabbits was used for testing each substance.
- GLP compliance:
- no
- Remarks:
- Study carried out prior to introduction of GLP
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4, 24 and 48 hours
- Number of animals:
- 6
- Details on study design:
- A series of 6 rabbits was used for testing this substance. Hair was clipped using angora clippers. Four areas of the back, placed approximately 10 cm apart, were designated for the application of the patches. Areas 2 and 3 were abraded by making 4 epidermal incisions (two perpendicular to two others). The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape (occlusive application). The material to be tested (0.5 g) was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands. Upon removal of the pactches, the resulting reactions were evaluated on the basis of weighted scores.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 1.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Only erythema (score 2) was noted in all 6 animals 4h hours after removal of the patch. After 24 hours, score 1 and 2 were still noted in the animals after removal of the patch. These findings were completely reversible within 48 hours. No oedema were observed during the test period. Therefore, Malonic acid is mildly irritating to rabbit skin (primary irritation index 1.3).
- Executive summary:
Malonic acid is mildly irritating to rabbit skin, but not sufficient for CLP classification.
Reference
Primary Irritation Study
|
| Erythema-Eschar observation | Edema observation |
| ||||
Rabbit # | Skin | 4 hr | 24 hr | 48 hr | 4 hr | 24 hr | 48 hr | Average |
1 | Intact | 2 | 1 | 0 | 0 | 0 | 0 | 1.17 |
| Abraded | 2 | 1 | 0 | 1 | 0 | 0 | |
2 | Intact | 2 | 1 | 0 | 0 | 0 | 0 | 1.33 |
| Abraded | 2 | 1 | 0 | 1 | 1 | 0 | |
3 | Intact | 2 | 1 | 0 | 0 | 0 | 0 | 1.0 |
| Abraded | 2 | 1 | 0 | 0 | 0 | 0 | |
4 | Intact | 2 | 2 | 0 | 0 | 0 | 0 | 2.0 |
| Abraded | 2 | 2 | 1 | 1 | 1 | 1 | |
5 | Intact | 2 | 1 | 0 | 0 | 0 | 0 | 1.0 |
| Abraded | 2 | 1 | 0 | 0 | 0 | 0 | |
6 | Intact | 2 | 1 | 0 | 0 | 0 | 0 | 1.17 |
| Abraded | 2 | 1 | 0 | 1 | 0 | 0 | |
Primary Irritation Index of Compound 1.3 (Mild primary irritant) |
|
| Individual Scores – rabbit no | |||||
Skin Reaction | Reading (hours) | 1 | 2 | 3 | 4 | 5 | 6 |
Erythema/Eschar | 4 | 2 | 2 | 2 | 2 | 2 | 2 |
24* | 1 | 1 | 1 | 2 | 1 | 1 | |
48* | 0 | 0 | 0 | 0 | 0 | 0 | |
72 |
|
|
|
|
|
| |
Total of * |
| 1 | 1 | 1 | 2 | 1 | 1 |
Mean values of * |
| 0.5 | 0.5 | 0.5 | 1.0 | 0.5 | 0.5 |
| |||||||
Edema | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
24* | 0 | 0 | 0 | 0 | 0 | 0 | |
48* | 0 | 0 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | 0 | 0 | |
Total of * |
| 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Mean values of * |
| 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Overall mean of * for Erythema/Eschar = 0.6
Overall mean of * for Edema = 0.0
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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)
- 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
- 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
- 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.
- Irritation parameter:
- other: Percentage of viability (relative to negative control)
- Value:
- 3.815
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- 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 %.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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