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EC number: 224-030-0 | CAS number: 4170-30-3
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: full study report available
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Principles of method if other than guideline:
- none
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Crotonaldehyde
- EC Number:
- 224-030-0
- EC Name:
- Crotonaldehyde
- Cas Number:
- 4170-30-3
- Molecular formula:
- C4H6O
- IUPAC Name:
- but-2-enal
- Details on test material:
- Lot #R6870, Batch 02 from Midwest Research Institute
recieved on Nov 20 1984 and Dec 4 1984
stored at 4C
100% purity listed on msds (98.8 % by analysis)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- none
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- corn oil
- Details on exposure:
- 2.5 ml gavage daily
- Details on mating procedure:
- males dosed 61 d prior to breeding and females dosed 31 days prior to breeding.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- 98.8% purity
- Duration of treatment / exposure:
- Males were dosed 61 prior to breeding and terminated after breeding at day 71.
Females were sacrificed day 5 postpartum and non-pregnant at day 99 (68 days of dosing) - Frequency of treatment:
- daily
- Details on study schedule:
- None
- No. of animals per sex per dose:
- 20
- Details on study design:
- None
- Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- Male and female: no notable clinical observations.
- Oestrous cyclicity (parental animals):
- gulati and russel, 1987
- Sperm parameters (parental animals):
- gulati and russel, 1987
- Litter observations:
Mean weights were the same at day 0 and day 5.
Clinical observations revealed no compound realted abnormalities.- Postmortem examinations (parental animals):
- No statitistically significant changes in mean testes or epididymis weights , Compound related histomorphologic alterations wewre not observed in the testes or epididymides.
No compound related -histomorphological alterations in the ovaries, oviducts, uterus, cervix or vagina. - Postmortem examinations (offspring):
- None
- Statistics:
- body weight gains, organ weights adn organ/body ratios of the control gruop were compared statistically to the data from the same sex of the treated groups. If variances of untransformed data were heterogeneous, analyses were performed on transformed data to achieve variance homogeneity by Levene;s test. All values were homogeneous. Group comparisons were performed routinely (Dunnett's t test) at 5% two tailed probability level unless otherwise specified
- Reproductive indices:
- female fertility was shown to be 83, 93, 100 and 88% in the 0, 2.5, 5 and 10 mg/kg groups respectively
male fertility showed success rates of 90, 75, 84.2 and 85 % for the 0, 2.5, 5 and 10 mg/kg groups respectively - Offspring viability indices:
- gestation index = 100%
viability index = was comparable among all groups.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day
- Sex:
- female
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day
- Sex:
- male
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 10 mg/kg bw/day
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- NOAEL of 10 mg/kg bw in male and female parental animals as well as F1 generation. No LOAEL identified.
- Executive summary:
In this subchronic reproductive study, 20 rats (F344) of each sex were randomized into three dose groups (2.5, 5 and 10 mg crotonaldehyde per kilogram body weight), and on control group (corn oil) and gavaged daily wiht 2.5 ml/kg until sacrifice. Males were dosed at 61 days prior to breeding. The males were terminated after breeding at Days 71 and 72. Females were dosed for 31 days prior to breeding. THe females were sacrificed at day 5 postpartum, as were the pups. Non-pregnant females were terminated at Day 99 (after 68 days of dosing).
One male from the 5 mg/kg group was found dead during week 2. There were no notable clinical observations in the males. There were no statistically significant changes in the mean testes or epididymis weights in any of the treatment groups when compared to controls. Compound-realted histomorphologic alterations were not observed in the testes or epididymides.
All females survived to scheduled sacrifice. Clininal observations in the females were not notable. There were no compound related histomorphologic alterations in the ovaries, uterus, oviducts, vagina or cervix.
Female fertility was shown to be 83, 93, 100 and 88% in the 0, 2.5, 5 and 10 mg/kg bw groups, respectively. Male fertility showed success rates (sperm or plug positive females) of 90, 75, 84.2 and 85 % for 0, 2.5, 5 and 10 mg/kg bw groups respectively.
The gestation index(number of live litters/number of pregnancies) was 100% for all groups. The viability index (number of pups surviving to day 5/number of pups born alive) was also comparative among all groups: 99.2, 100, 98.9 and 100 for the 0, 2.5, 5 and 10 mg/kg bw groups, respectively. The mean group weights of live pups taken at day 0 were similar as were mean group weights at day 5. Clinical observation in pups at days 0 and 5 did not reveal any compound-related abnormalities.
In conclusion, under conditions of this study, crotonaldehyde administered at dose levels up to 10 mg/kg from prior to breeding through delivery did not produce and toxicoloical effects in gonadal function, mating behavior and fertility of male and female F344 rats.
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