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EC number: 207-975-3 | CAS number: 503-74-2
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isovaleric acid
- EC Number:
- 207-975-3
- EC Name:
- Isovaleric acid
- Cas Number:
- 503-74-2
- Molecular formula:
- C5H10O2
- IUPAC Name:
- 3-methylbutanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Isovaleriansäure; substance No. 77/520
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- 8 days
- Number of animals:
- 2 (1hr) and 4 (3 min exposure)
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: BASF; similar to the table of Draize contained in the OECD test guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- skin contact: 1hr
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Contact period 1 hour in this and following lines.See also section "Any other information on results incl. tables" below.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: day 1
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: necrosis in one animal
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: day 2
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis in both animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: day 8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis in both animals; scoring of skin reaction not possible
Any other information on results incl. tables
Table 1: skin reactions following a 1-hour exposure. Findings were confirmed by pathologist.
animal |
1 hour |
Day 1 |
Day 2 |
Day 8 |
||||
|
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
1 |
2ext |
2ext |
4 N |
2ext |
4 N |
2ext |
N d |
2ext |
2 |
2ext |
2ext |
2ext N |
2ext |
4 N |
2ext |
N d |
2ext |
Table 2: skin reactions following a 3-minute exposure. Findings were confirmed by pathologist.
animal |
1 hour |
Day 1 |
Day 2 |
Day 8 |
||||
|
erythema |
edema |
erythema |
edema |
erythema |
edema |
erythema |
edema |
1 |
2ext |
2ext |
4 N |
2ext |
4 N |
2ext |
4 N |
2ext |
2 |
2 |
sup |
2ext N |
2 |
2ext N |
2ext |
Sup N |
1 |
3 |
1ext |
sup |
4 N |
2ext |
4 N |
2ext |
4 N |
2 |
4 |
2ext |
sup |
2ext |
2ext |
2ext |
3ext |
2 |
2 |
Legend:
grading 1, 2, 3, 4: according to table in OECD 404 (1992)
ext = exteing beyond area of exposure
N = necrosis; N
d = deep, entire skin (= full thickness)
Sup = superficial
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Following a 1- hour exposure period isovaleric acid caused full thickness necrosis of the rabbit's skin. Classification (skin corrosion, Cat 1B) is required.
- Executive summary:
Isovaleric acid caused irreversible skin reactions and necrosis of the rabbit's skin following a 1-hour skin contact period. Skin contact for 3 minutes caused also necroses, but these were seen one day after the treatment. The study was equivalent to OECD 404 (adopted 1992); (BASF, 1980).
The study is considered to be valid for assessment. According to the regulation EC/1272/2008 isovaleric acid was corrosive to the skin and requires Cat 1B classification.
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