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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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 (LC50 not statistically determined, no concentrations and particle size distribution measured, only 6 rats used, sex not specified, reporting not according to test guideline)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- only 4 animals per group, occlusive wrapping, limited reporting
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- 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
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- yes
- 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 - 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 animals 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.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 857 mg/kg bw
- Remarks on result:
- other: LD50 is originally reported in mL/kg bw
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 was 4857 mg/kg bw in male rabbits. No classification is required according to Regulation (EC) 1272/2008.
- Executive summary:
The acute dermal toxicity of valeraldehyde 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 valeraldehyde was determined to be 4857 mg/kg bw in rabbits (Smyth, 1969).
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.
The acute dermal LD50 was reported as 6 mL/kg bw. Using a density of 0.8095 g/mL (Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988), the LD50 calculates to 4857 mg/kg bw. There is no information on local effects reported.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- limited reporting on test substance and test performance
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- non fasted animals, limited reporting
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Carworth-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breeding
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 990 to 120 g
- Fasting period before study: no
- Housing: no data
- Diet (e.g. ad libitum): Rockland rat diet, complete
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Whenever possible, the test substance was administered undiluted.
- Doses:
- Doses were arranged in a logarithnic series differing by a factor of two.
No data on individual doses. - No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- 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 (Thompson WR 1947, Bacteriol Rev 11, 115) using the Tables of Weil (Weil GS 1952, Biometrics 8, 249). The figures in parentheses show the limits of +/- 1.96 standard deviations.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 582 mg/kg bw
- Remarks on result:
- other: Highest dose tested; no fractional mortality was observed with the various doses tested; no limits of standard deviation could be calculated.
- Mortality:
- None of the doses tested resulted in fractional mortality. No mortality was observed even at the highest dose tested.
- Interpretation of results:
- other: GHS critertia under EU CLP (1272/2008/EC) not met
- Conclusions:
- The acute oral LD50 of valeraldehyde is > 4582 mg/kg bw (highest dose tested, no mortality). No classification is required according to EU CLP (1272/2008/EC).
- Executive summary:
The acute oral toxicity of valeraldehyde was determined in groups of 5 male Carworth-Wistar rats receiving the test material by oral gavage. The doses were spaced by a factor of 2 (logarithmically). The observation period was 14 days. The LD50 was calculated according to the method of Thomson (1947). No fractional mortality was observed for valeraldehyde at the various doses tested. Thus there was no mortality at the highest dose tested. No limits of standard deviations could be calculated. Overall the study was conducted in accordance with the recently retracted OECD test guideline 401.
The acute oral LD50 was determined to be > 4582 mg/kg bw in rats (Smyth et al., 1969) (LD0 = 4582 mg/kg bw).
The highest tested dose is reported as 5.66 mL/kg bw. Using a density of 0.8095 g/mL (Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988), this value is converted to 4582 mg/kg bw.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- test substance application (amount, concentration) and evaluation (scoring) of eye reactions not according to OECD test guideline 405 or Draize.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pre-guideline study; primary eye irritation test, but quantity of test substance applied and scoring system (reference 2: Carpenter, 1946) are study specific and different from OECD TG 405 or Draize.
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye of the animal
- Amount / concentration applied:
- 0.005 and 0.02 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24 h
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: specific proprietary scoring system different from the system of Draize or OECD TG 405
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: visual examination in strong diffuse daylight and after staining with fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Remarks on result:
- other: distinct grading system different from grading scores of OECD TG 405 or Draize
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test result indicate that the test substance causes severe eye injury. Due to methodological deficiencies, this study cannot be used for classification.
Application of 0.005 mL of pure test substance for 24 hours caused an injury grade 5 (severe eye injury) of a scale with a maximum score of 10. The specific character and severity of the eye injury cannot be extracted from the score.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- test substance volume only 0.01 ml; evaluation of skin reactions not according to OECD test guideline 404 or Draize, application site: belly
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Primary skin irritation test, but only 0.01 mL of test substance is applied, specific grading system different from OECD TG 404 or Draize.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.01 mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- no data
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: rabbit belly
- % coverage: no data
- Type of wrap if used: application site uncovered
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM: own scoring sytem ranging from grade 1 (no reaction from undiluted sample) to grade 10 (edema as maximum reaction from diluted (aceton) sample, concentration < 0.01%) - Irritation parameter:
- overall irritation score
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 10
- Remarks on result:
- other: distinct grading system, score 2 indicates weak reaction (least visible capillary injection)
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this primary irrtiation test (0.01 mL of test substance administered), valeraldehyde was found to be only very weakly irritating to rabbit skin (barely perceptible capillary injection). However, due to methodological deficiencies this study cannot be used for classification according to Regulation (EC) 1272/2008.
Primary irritation was recorded in a 10-grade ordinal series of a dose-related reaction: Here the reaction score is 2, indicating a week irritation reaction (least visible capillary injection).
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- LC50 not statistically derived, no actual concentrations and particle size distribution measured, only 6 rats used, sex not specified, reporting not according to test guideline
- Principles of method if other than guideline:
- Pre-guideline study, but method is similar to OECD TG 403. A test with graduate doses (standard test) and an inhalation hazard test were performed.
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
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): valeraldehyde
- no further information on test substance
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breeding facility
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 g
- Fasting period before study: no
- Housing: no data
- Diet (e.g. ad libitum): Rockland rat diet, complete, ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Test with graduate doses (standard test)
Test atmosphere was generated by injecting definite amounts of test substance into the flowing stream of breathing air using a suitable proportioning pump.
Inhalation hazard test
Test atmosphere was generated by passing a stream of dried air at 2.5 L/min at room temperature through a fritted glass disc immersed to a depth of at least 1 inch in approximately 50 mL of the test substance contained in a gas washing bottle. Six male or female albino rats were exposed for different exposure times to this atmosphere (flowing stream of air saturated or close to saturation with vapour). - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Remarks on duration:
- test with graduate doses
- Concentrations:
- For the standard test, doses were spaced in a logarithmic series with a factor of 2. Number of doses and individual concentrations are not reported.
For the inhalation hazard test, the test atmosphere was saturated or close to saturation with test substance vapor as indicated by the generation method of test atmosphere (saturated vapor concentration of valeraldehyde: 92 mg/L at 20°C according to Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988) - No. of animals per sex per dose:
- six male or female animals per dose
- Control animals:
- not specified
- 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
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- 14.3 mg/L air (nominal)
- Exp. duration:
- 4 h
- Remarks on result:
- other: Standard test: at the given dose, 3 of 6 animals died. Dose is converted from ppm as reported by the authors (4000 ppm)
- Sex:
- not specified
- Dose descriptor:
- discriminating conc.
- Effect level:
- ca. 92 mg/L air (nominal)
- Exp. duration:
- 15 min
- Remarks on result:
- other: Inhalation Hazard Test: as discriminating dose the saturated vapor concentration of test substance is given. Exposure duration is the longest exposurte time resulting in no death
- Mortality:
- After exposure for 4 hours to a concentration of 4000 ppm test substance (ca. 14.3 mg/L; conversion factor from ppm to µg/L = 3.58, Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988), 3 of 6 animals died within 14 days. This concentration is taken as LC50.
For the exposure to (nearly) saturated vapor, the exposure time was restricted to 15 min in order to produce no mortality.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Exposure to valeraldehyde vapor in air at a concentration of 14.3 mg/L (4000 ppm) for 4 hours resulted in the death of 3 out of 6 animals (observation period 14 days). This value indicates LC50 and corresponds to category 4 for acute inhalation toxicity according to EU regulations (Regulation (EC) 1272/2008).
- Executive summary:
For this acute inhalation toxicity study, a standard graduate dose test and an inhalation hazard test were performed. The observation period for both tests was 14 days.
Groups of six albino rats were exposed for 4 hours to graduate doses of valeraldehyde vapor in the breathing atmosphere of test animals. Doses were spaced in a logarithmic series with a factor of 2. Actual concentrations were not measured and individual doses are not reported.
In the inhalation hazard test, test animals were exposed for various time periods starting from one forth hour up to 8 hours (if appropriate, spacing factor of 2) to an atmosphere saturated or close to saturation with vapor of valeraldehyde. Actual atmosphere concentrations were not measured but can be estimated to be saturated or close to saturation by the method the atmosphere was generated. Saturated vapor concentration of valeraldehyde at 20°C in air is 92 mg/L (Auer Technikum, Edition 12, Auergesellschaft GmbH, Berlin, 1988).
In the standard test, a concentration of 4000 ppm (ca. 14.3 mg/L) caused a mortality of 3 of 6 animals. This concentration represents the LC50.
In the inhalation hazard test (saturated vapor), the exposure time was restricted to 15 min in order to produce no mortality.
A LC50 value using a statistical method was not determined. But the concentration causing 3 deaths out of 6 animals is considered to represent the LC50. Thus the concentration of 14.3 mg/L (4000 ppm) is taken as LC50 value (Smyth 1969).
Standards of the OECD test guideline 403 (Acute Inhalation Toxicity) are only met with restrictions by this investigation (only 6 rats used, sex not specified, no concentrations measured, deficiencies in reporting). Due to the high volatitiy of the test substance, the nominal concentrations are estimated to be close to the actual concentrations.
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