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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 203-957-4 | CAS number: 112-31-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study meets generally accepted scientific standards with acceptable restrictions for the standard test.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Unclear; makes reference to FDA (1987)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- no details specified
- Limit test:
- yes
Test material
- Reference substance name:
- Heptanoic acid
- EC Number:
- 203-838-7
- EC Name:
- Heptanoic acid
- Cas Number:
- 111-14-8
- Molecular formula:
- C7H14O2
- IUPAC Name:
- heptanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Aldehyde, 5-heptenal, 2,6-dimethyl
- Molecular formula: C₇H₁₄O₂
- Molecular weight: 310.079
- Smiles notation: O=C(O)CCCCCC
- InChl: InChI=1S/C7H14O2/c1-2-3-4-5-6-7(8)9/h2-6H2,1H3,(H,8,9)
- Structural formula attached as image file
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- 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: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum):No data
- Water (e.g. ad libitum):No data
- Acclimation period:No data
- Other: Nulliparous
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food):No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle: No data
- Concentration in vehicle: No data
- Amount of vehicle: 5 mL/kg bw/d - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 1 week treatment followed by 7 d cohabitation period through gestation, parturition and 4-d postpartum period.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 females per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE-SIDE OBSERVATIONS
- Viability was monitored twice daily during the study.
- Rats were observed daily for clinical signs approx. 30 mins after gavage administration.
BODY WEIGHT
- Measurement of body weight was performed weekly.
FOOD CONSUMPTION
- Food consumption measurement was also conducted weekly during the premating/premating period and then on days 0, 6, 14, 16, 21, and 25 of gestation and on days 1 and 4 of lactation/postparturition.
MATING PERFORMANCE
- Mating performance was evaluated daily during the cohabitation period.
- Dams were evaluated daily during gestation for duration of gestation, maternal behaviour, litter size and pup viability. - Oestrous cyclicity (parental animals):
- Mating, day 0 of gestation identified on basis of spermatozoa in vaginal smear.
- Postmortem examinations (parental animals):
- SACRIFICE
- Dams that did not deliver litters were sacrificed on day 25 of presumed gestation and dams that did deliver litters were sacrificed on days 4 or 5 of lactation. All dams were examined for gross lesions and implantation sites.
GROSS NECROPSY
- Ovaries from all dams and any observed gross lesions were preserved in neutral 10% formalin for possible evaluation. - Postmortem examinations (offspring):
- GROSS NECROPSY
- Vital signs at birth were determined for pups that were stillborn or died before the initial examination of the litter.
- Each litter was evaluated for viability a minimum of twice daily during the 4-day lactation period.
- Dead pups were removed and necropsied.
- Tissues with gross lesions were preserved for possible examination.
- Pups in each litter were counted and observed for nursing behaviour and physical abnormalities daily.
- Pup body weights were measured on days 1 and 4 of postpurition. - Statistics:
- Fisher's ANOVA followed by Dunnett's test
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- MORTALITY
- 1 and 3 deaths were reported in the 1000 and 2000 mg/kg bw/day dose groups, respectively. - Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
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)
- 1 and 3 deaths were reported in the 1000 and 2000 mg/kg bw/day dose groups, respectively.
CLINICAL SIGNS
- Clinical signs at 200 mg/kg bw/day in dams during premating and gestation included a significant increase in rales (P<0.01). This effect was not
reported during the lactation period. In the 1000 and 2000 mg/kg bw/day dose group, significant increases in the incidence of rales (P<0.01), excess salivation (P<0.01) was reported during premating and gestation. Excess salivation continued during lactation in the high-dose group.
- Other significant (P<0.01) effects during gestation in the high-dose group included decreased activity, ungroomed coat and labored breathing.
BODY WEIGHTS
- The 2000 mg/kg bw/day group showed reduced body weight gains during premating, and significantly (P<0.05 to <0.01) decreased average maternal body weights on days 10 and 16 of gestation.
FOOD CONSUMPTION
- Average and relative food consumption was reduced in the high-dose group of dams throughout the study. The high dose also was associated with reduced mating and fertility that were related to mortality.
COHABITATION INDICES
-The duration of cohabitation and fertility and gestation indices 200, 1000, or 2000 mg/kg bw/day were not different from comparable indices in thee control group.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- mortality
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 1 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- mortality
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
- The high-dose group exhibited reduced pup weights on day 4 postparturition.
OTHER
No biologically relevant or statistically significant differences in the number of implantations, duration of gestation, the percentage of dams delivering one or more live pups, and the pup viability index were observed.
GROSS PATHOLOGY
- No malformations or gross lesions were observed in pups at any dose levels.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- yes
Applicant's summary and conclusion
- Conclusions:
- The test substance was assessed for toxicity to reproduction in a one-generation test, using rats exposed to the test substance via oral gavage. Dose levels of 200 mg/kg bw/day of heptanoic acid had no significant adverse effects on the reproductive performance of female Sprague-Dawley rats or the growth or development of their offspring.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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