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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- 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): n-Valeraldehyde
- Test substance No.: 06/0576-1
- Batch No.: Verkaufstank B533 v. 05.09.06
- Purity: >99%
- Homogeneity: given
- Stability: The stability will be verified by reanalysis after completion of the administration period of the subsequent guideline study
- Date of production September 05, 2006
- Physical state / Appearance: Liquid/colorless, clear
- Storage conditions: Refrigerator (KS), under N2, under light exclusion
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on days 7, 14 and 29
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on days 7, 14 and 29 - Other examinations:
- The plasma metabolome was examined by metanomics GmbH after appropriate sample work up using GC/MS and LC/MS techniques. Test substance related changes in the metabolome were compared to typical metabolite profiles (up- and down-regulations of the analytes) of known toxicological modes of action. Based on these evaluations, the toxicological mode of action (including target organs and toxic mechanisms) of the test substance was assessed.
Results and discussion
Results of examinations
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Details on results:
- 1000 mg/kg bw:
- N-VALERALDEHYDE showed almost no changes in the metabolite profile compared to the control in both sexes (p < 0.05; based on 290 metabolites).
- The metabolite profile of N-VALERALDEHYDE in both sexes did not match with the specific metabolite profiles of a number of modes of action in the MetaMapTox database: males: the best matches were with compounds that did not indicate a clear spectrum of toxicity (up to 28 % concordance). females: the best matches were also with compounds that did not indicate a clear spectrum of toxicity (up to 17 % concordance).
- N-VALERALDEHYDE did not match established metabolite profiles for specific toxicity in both males and females.
300 mg/kg bw:
- N-VALERALDEHYDE showed almost no changes in the metabolite profile compared to the control in both sexes (p < 0.05; based on 290 metabolites).
- The metabolite profile of N-VALERALDEHYDE in both sexes did not match with the specific metabolite profiles of a number of modes of action in the MetaMapTox database: males: the best matches were with compounds that did not indicate a clear spectrum of toxicity (up to 25 % concordance).
females: the best matches were also with compounds that did not indicate a clear spectrum of toxicity (up to 29 % concordance).
- N-VALERALDEHYDE did not match established metabolite profiles for specific toxicity in both males and females.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: clinical signs; body weight; food consumption haematology; clinical chemistry; organ weights
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Results:
- N-VALERALDEHYDE showed almost no changes in the metabolite profile compared to the control in both sexes (p<0.05; based on 290 metabolites):
dose group | sex | Change compared to control | d 7 | d 14 | d 28 |
1000 mg/kg bw | males | up | 2 | 9 | 7 |
down | 2 | 0 | 2 | ||
females | up | 14 | 2 | 5 | |
down | 1 | 6 | 3 | ||
300 mg/kg bw | males | up | 3 | 1 | 0 |
down | 3 | 1 | 5 | ||
females | up | 11 | 9 | 3 | |
down | 3 | 7 | 3 |
Applicant's summary and conclusion
- Conclusions:
- Based on the metabolome analysis it is concluded that n-valeraldehyde is unlikely to have a significant systemic toxicological potential in oral studies in rats.
- Executive summary:
5 male and female Wistar rats were treated with valeraldehyde via oral gavage for 28 days at doses of 300 and 1000 mg/kg bw. There were signs of toxicity during clinical observations. No changes in food consumption, body or organ weights was observed.
n-valeraldehyde showed almost no changes in the metabolite profile compared to the control in both sexes (p<0.05; based on 290 metabolites). The metabolite profile of n-valeraldehyde in plasma does not match well with any of the reference compounds or established toxicological modes of action at the dose levels tested. Based on the metabolome analysis it is concluded that v-valeraldehyde is unlikely to have a significant systemic toxicological potential in oral studies in rats.
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