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Diss Factsheets
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EC number: - | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: Information on metabolite lauric acid.
- Adequacy of study:
- other information
- Study period:
- 1994
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Does not meet important criteria for today's standard method. Study uses a single dose on day 12 of gestation using a small number of test animals.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: An embryotoxicity study of octanoic acid in rats was performed.
- Short description of test conditions:In this study 12 pregnant female rats were dosed with 18.75 mmol/kg of octanoic acid on day 12 of pregnancy. The rats were then sacrificed on day 20 of pregnancy.
- Parameters analysed / observed: The number of fetuses and resorptions counted. The fetuses were also checked for malformations and weight - GLP compliance:
- not specified
Test material
- Details on test material:
- Purity: no data
Carbon chain length distrbution: C8
Source: Material was purchased from Sigma Chemical Company, St Louis, MO.
Remarks: Octanoic acid was one of 4 test materials included in the study.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sigma Chemical Company
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: day 6 or 7 of pregnancy
- Housing: small groups in hanging wire cages
- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 to 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 50 +/- 5
- Photoperiod (hrs dark / hrs light): 12 hrs light/dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- day 12 of gestation
- Frequency of treatment:
- single
- Duration of test:
- eight days (single dose on day 12 of gestation, with sacrifice on day 20)
Doses / concentrations
- Dose / conc.:
- 18.75 other: mmol/kg
- No. of animals per sex per dose:
- 12
- Control animals:
- other: 10 undosed animals
Examinations
- Ovaries and uterine content:
- On day 20 of gestation, animals were sacrificed, and the uterine horns were examined for placement of fetuses and counting of resorption sites.
- Fetal examinations:
- Fetuses were weighted and the sexes were determined. Fetuses were also examined for gross malformations, and fixed in either Bouin's fluid for razor blade sectioning and examination, or alcohol for staining for cartilage and bone examination.
- Statistics:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 1 of the 12 animals did not survive until the end of the study.
Maternal developmental toxicity
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 10 (9%)
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 18.75 other: mmol/kg
- Based on:
- test mat.
- Basis for effect level:
- mortality
Results (fetuses)
- Fetal body weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- mean fetal weight (M/F): control: 3.9/3.71, test 3.48/3.23
- Reduction in number of live offspring:
- effects observed, non-treatment-related
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- # of malformed surviving fetuses: control 1%, test 3%
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
no embryotoxic effects except a slight reduction on fetal body weight
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 18.75 other: mmoles/kg
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Key result
- Abnormalities:
- not specified
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Additional transplacental pharmacokinetic studies indicated that octanoic acid is poorly absorbed via the intestinal tract.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL (teratogenicity) was 18.75 mmoles/kg.
- Executive summary:
An embryotoxicity study of octanoic acid was performed. In this study 12 pregnant female rats were dosed with 18.75 mmol/kg of octanoic acid on day 12 of pregnancy. The rats were then sacrificed on day 20 of pregnancy, and the number of fetuses and resorptions counted. The fetuses were also checked for malformations and weight. Only one of the 12 female rats did not survive until sacrifice. The fetal observations are summarized below:
No. implantation sites: control 108, test 131
No. of resorption or dead fetuses: control 6%, test 9%
No. of malformed surviving fetuses: control 1%, test 3%
Mean fetal weight (M/F): control: 3.9/3.71, test 3.48/3.23
Additional transplacental pharmacokinetic studies indicated that octanoic acid is poorly absorbed via the intestinal tract.
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.
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