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EC number: 203-784-4 | CAS number: 110-62-3
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Valeraldehyde
- EC Number:
- 203-784-4
- EC Name:
- Valeraldehyde
- Cas Number:
- 110-62-3
- Molecular formula:
- C5H10O
- IUPAC Name:
- pentanal
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): n-Valeraldehyde
- Physical state: colorless, clear liquid
- Analytical purity: 98.5% (GC)
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: Tank 301/T 602
- Stability under test conditions: assumed stable
- Storage condition of test material: refrigerator, exclusion of light and oxygen (under nitrogen)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adults
- Weight at study initiation: 3.7, 3.65, and 3.7 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet (e.g. ad libitum): Kliba-laboratory animal diet, Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): municipal tap water, ca. 250 mL per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 /12, 6:00 to 6:00
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: semiocclusive (Idealbinde from Pfaelzische Verbandstoff-Fabrik, Kaiserslautern, FRG) and Fixomull stretch (adhesive fleece) from Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- For animal 2 and 3, erythema and edema were extending beyond the area of exposure during the period of maximum irritation response (1 h to 72 h after removal of the patch)
Any other information on results incl. tables
Skin irritation effects resulting from administration of 0.5 mL of valeraldehyde to rabbits
Readings (time after removal of patch) |
Animal 1 |
Animal 2 |
Animal 3 |
|||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1h |
2 |
0 |
2 |
2 |
2 |
1 |
24 h |
1 |
0 |
3 |
1 |
2 |
1 |
48 h |
0 |
0 |
3 |
1 |
2 |
0 |
72 h |
sd |
sd |
3 |
1 |
2 |
0 |
7 d |
sd |
sd |
2 |
1 |
1 |
0 |
14 d |
sd |
sd |
2 |
0 |
0 |
0 |
Mean (24 - 72 h) |
0.33 |
0 |
3 |
1 |
2 |
0.33 |
sd = study discontinued because the animal was free of symptoms
For animal 2 and 3, erythema and edema were extending beyond the area of exposure during the period of maximum irritation response (1 h to 72 h after removal of the patch)
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Erythema was noted starting from 1 h after removal of the patch (all 3 animals) up to 14 days (1 animal) with maximum scores of 3. Edema was less pronounced (only 2 animals, shorter period, maximum score of 2). Classification criteria of Directive 67/548/EEC and Regulation (EC) No. 1272/2008 are exceeded requiring classification of valeraldehyde as irritating to skin.
- Executive summary:
In a primary dermal irritation study according to OECD test guideline 404 (Acute Dermal Irritation/Corrosion), three young adult male New Zealand White rabbits were dermally exposed to 0.5 mL of valeraldehyde (purity 98.5%) for 4 hours applied to a 2.5 x 2.5 cm clipped body surface area. Animals then were observed for 14 days. Irritation was scored according to the grading system of OECD test guideline 404 (method of Draize).
Erythema was noted starting from 1 h after removal of the patch (all 3 animals) up to 14 days (1 animal) with maximum scores of 3. Edema was less pronounced (only 2 animals, shorter period, maximum score of 2). Mean erythema and edema scores (24. 48, and 72 h, all animals) were 1.78 and 0.44 respectively. In this study, valeraldehyde was demonstrated to be a dermal irritant (BASF 1999).
This study is rated as acceptable. It satisfies the requirement of OECD Test Guideline 404 for skin irritation/corrosion.
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