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EC number: 941-032-3 | CAS number: -
- 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:
- other: see 'Remark'
- Remarks:
- Review and collection of existing data. Though secondary literature, the reliability is regarded as being high (RL=2) because guideline studies according to OECD 405 and conducted under GLP were assessed and referenced (deviations of the actual tests from test guideline: observation period only 7 days).
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : observation period only 7 days
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isovaleraldehyde
- EC Number:
- 209-691-5
- EC Name:
- Isovaleraldehyde
- Cas Number:
- 590-86-3
- IUPAC Name:
- 3-methylbutanal
- Details on test material:
- - Name of test material (as cited in study report): 3-methylbutyraldehyde
- Analytical purity: >98.5%
- Impurities (identity and concentrations): no data
- Stability under test conditions: yes
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- according to OECD test guideline 404
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7
- Number of animals:
- 4
- Details on study design:
- according to OECD test guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 2.83
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: at day 7, erythema and edema scores had subsided, but skin irritation had not disappeared completely.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.42
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Grading scores for day 7 are displayed below under Remarks on results
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.58
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: almost fully reversible within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.83
- Max. score:
- 4
- Reversibility:
- other: almost fully reversible within 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- other: almost fully reversible within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- At day 7, markde desquamation from the skin was observed for animal 3 and 4.
Any other information on results incl. tables
Grading Scores of Skin Reactions
|
Animal 1 |
Animal 2 |
Animal 3 |
Animal 4 |
||||
Observation time (day after patch removal) |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 (hour) |
2 |
2 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
2 |
2.5 |
2 |
1.5 |
2 |
1 |
1 |
1 |
2 |
2 |
2 |
2 |
1.5 |
1 |
0 |
1 |
1.5 |
3 |
2 |
1.5 |
1.5 |
1 |
0.5 |
0 |
2 |
1.5 |
7 |
1 |
0.5 |
0.5 |
0 |
1 * |
1 |
0.5 * |
0 |
Mean (day 1 to 3) |
2 |
2 |
1.83 |
1.33 |
1.17 |
0.33 |
1.33 |
1.33 |
* marked desquamation from the skin
In this study, skin reactions were only observed for 7 days after removal of the patch. No data are reported for day 14.
At day 7, scores of skin reactions had decreased after passing peaks between day 1 and 3. But the effects of skin irritation had not completely disappeared. Based on the low level of irritation scores at day 7 (maximum score 1), it is estimated that skin reaction is fully reversible within 14 days.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Isovaleraldehyde caused slight irritation after application of 0.5 mL on the rabbit's skin after a 4-h contact period. Overall irritation score for time periods 24, 48, and 72 h was 1.42 with highest individual scores of 2 and 2.5 (erythema and edema respectively). After 7 days, skin reactions had almost completely subsided. Based on the 7 day scores, It is estimated that skin reactions are reversible within 14 days.
- Executive summary:
In a primary dermal irritation study according to OECD test guideline 404 and conducted under GLP conditions, four albino rabbits were dermally exposed to 0.5 mL of isovaleraldehyde (3-methylbutyraldehyde) (purity 98.5 %) for 4 hours. Animals were then observed for 7 days but not for 14 days. Irritation was scored by the method of Draize/OECD test guideline 404.
Skin reactions could be observed in all animals starting 1 h after removal of the patch with a maximum erythema and edema score of 2 and 2.5 respectively (day 1). Scores had subsided at day 7 but irritation effects had not completely disappeared. Considering the day 7 scores, it is estimated that irritation effects are reversible within 15 days.
Isovaleraldehyde is slightly irritating to the skin but it does not require classification according to EU regulations based on irritation scores and reversibility of irritating effects (ECETOC, 1995).
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