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Diss Factsheets
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EC number: 941-031-8 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (only 4 animals per group, occlusive wrapping, limited reporting)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- : only 4 animals per group, occlusive wrapping, limited reporting
- Principles of method if other than guideline:
- Pre-guideline study, but method used is similar to OECD TG 402.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isovaleraldehyde
- EC Number:
- 209-691-5
- EC Name:
- Isovaleraldehyde
- Cas Number:
- 590-86-3
- Molecular formula:
- C5H10O
- IUPAC Name:
- 3-methylbutanal
- Details on test material:
- - Name of test material (as cited in study report): 3-Methylbutyraldehyde
- No further information on test substance
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: part of the trunk
- % coverage: no data
- Type of wrap if used: impervious plastic film
- Restraining of animals: animals are immobilized during the 24 h exposure period
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): graduate doses were applied, but individual doses are not specified - Duration of exposure:
- 24 hours
- Doses:
- no individual doses specified
- No. of animals per sex per dose:
- 4 male rabbits per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data - Statistics:
- LD50 values were calculated by the method of Thompson (1947, Bacteriol. Rev. 11, 115) using the tables of Weil (1952, Biometrics 8, 249. The limits of ± 1.96 standard deviations are presented.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 534 mg/kg bw
- Remarks on result:
- other: ± 1.96 standard deviations (1546 - 4128 mg/kg bw ); values are converted from mL/kg bw as reported by authors.
Any other information on results incl. tables
The acute dermal LD50 was reported as 3.18 mL/kg bw (1.94 - 5.18 mL/kg bw). The figures in parentheses show the limits of ± 1.96 standard deviations. Using a density of 0.7969 g/mL (Sect. 4.4), the LD50 calculates to 2534 mg/kg bw (1546 - 4128 mg/kg bw).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 was 2534 mg/kg bw in male rabbits. No classifcation required according to EU legislation.
- Executive summary:
The acute dermal toxicity of isovaleraldehyde (3 -methylbutyraldehyde) was determined in groups of 4 male albino New Zealand rabbits receiving graduate single doses of test substance per group. Number and quantity of individual doses are not specified. The exposure time was 24 hours followed by an observation period of 14 days. Individual data on mortality, weight development, clinical signs, and gross necropsy findings are not reported. From mortality data, the LD50 and a range of ± 1.96 SD was calculated according to the method of Thomson (1947).
The acute dermal LD50 for isovaleraldehyde was determined to be 2534 mg/kg bw in rabbits (Carpenter, 1974).
Overall, the study was conducted similar to OECD test guideline 402 with some restrictions (only 4 animals per group, occlusive wrapping, limited reporting). The deviations from the test guideline are considered not to invalidate the result. It is rather estimated that the value determined is close-by a result from a test in compliance with the test guideline and will be located within its range of uncertainty.
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