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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
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- 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
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
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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