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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
Endpoint summary
Administrative data
Description of key information
No other symptoms than respiratory irritation were noted in rats exposed for 7 hours at saturation concentration (approx. 2060 mg/m³, calculated).
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- 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 - 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
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
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 only one day after the treatment. The study was equivalent to OECD 404 (adopted 1992); (BASF, 1980).
No study was located for eye irritation. The substance is corrosive to the skin, therefore sufficient information is available for the classification of the substance, and no study is required.
Regarding respiratory irritation, symptoms were noted in the acute inhalation study where rats were exposed for 7 hours at saturation concentraton (approx. 2060 mg/m³, calculated) (BASF, 1980).
Justification for selection of skin irritation / corrosion endpoint:
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).
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Effects on respiratory irritation: irritating
Justification for classification or non-classification
According to the regulation EC/1272/2008 isovaleric acid was corrosive to the skin and requires Cat 1B classification (irreversible changes) following 1 hour of exposure. A 3 -minute exposure did also cause necrosis, but not within 1 hour. Classification into Cat 1A does therefore not apply.
According to regulation EC/1272/2008, section 3.3.2.3 skin corrosive substances shall be considered as leading to serious damage to the eyes as well (Category 1). This does apply to isovaleric acid and accordingly classification is proposed.
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