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EC number: 203-677-2 | CAS number: 109-52-4
- 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:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Unsuitable test sytem. Range-finding study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- Investigation of the tolerance/adverse effects (maternal toxicity and fertility) of test substance in pregnant rats by application of graduate doses of test substance from day 6 through day 15 of gestation.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Valeric acid
- EC Number:
- 203-677-2
- EC Name:
- Valeric acid
- Cas Number:
- 109-52-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- pentanoic acid
- Details on test material:
- - Name of test material (as cited in study report): C-180
- Physical state: clear colorless liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc., Kingston, NY, USA
- Age at study initiation: 12 weeks
- Weight at study initiation: 177 - 285 g
- Fasting period before study: no data
- Housing: induvidually in stainless steel wire-mesh cages
- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow, ad libitum
- Water (e.g. ad libitum): tap water (via water bottles), ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 25 - 56
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: September 16, 1981 To: November 7, 1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: dissolution of test substance in vehicle and subsequently stirring for 5 minutes
VEHICLE
- Justification for use and choice of vehicle (if other than water): suitable solvent
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 1.0 mL/kg bw for low dose group, 5.0 mL/kg bw for mid-dose group, 10.0 mL/kg bw for high dose group
- Lot/batch no. (if required): no data
- Purity: no data
Details on mating procedure
- M/F ratio per cage: 1/2
- Length of cohabitation: maximal 16 days
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After 9 days of unsuccessful pairing, females were rotated to males that had successfully mated
- Further matings after two unsuccessful attempts: no data
- After successful mating each pregnant female was caged (how): induvidually in stainless steel wire-mesh cages - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - M/F ratio per cage: 1/2
- Length of cohabitation: maximal 16 days
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After 9 days of unsuccessful pairing, females were rotated to males that had successfully mated
- Further matings after two unsuccessful attempts: no data
- After successful mating each pregnant female was caged (how): induvidually in stainless steel wire-mesh cages - Duration of treatment / exposure:
- from day 6 to day 15 of gestation (only dams)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 500, 1000 mg/kg bw and day
Basis:
actual ingested
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: not required for a range finding study
- Rationale for animal assignment (if not random): random assignment
- Other: only female animals were used, exposure period from day 6 to day 15 of gestation. Animals were killed after 15 days of gestation (Day 16).
Examinations
- Maternal examinations:
- SACRIFICE
- Male animals: no data; male animals were not examined.
- Maternal animals: dams were sacrificed by carbon dioxide asphyxiation on day 16 of gestation.
GROSS NECROPSY
- Gross necropsy was performed . The uterus of each female was examined to confirm pregnancy. The number of corpora lutea per ovary, the number and placement of uterine implantations, resorptions and live and dead fetuses were recorded.
HISTOPATHOLOGY / ORGAN WEIGHTS
- not examined - Ovaries and uterine content:
- GROSS NECROPSY
- Gross necropsy was performed . The uterus of each female was examined to confirm pregnancy. The number of corpora lutea per ovary, the number and placement of uterine implantations, resorptions and live and dead fetuses were recorded. - Fetal examinations:
- GROSS NECROPSY
- Gross necropsy was performed . The uterus of each female was examined to confirm pregnancy. The number of corpora lutea per ovary, the number and placement of uterine implantations, resorptions and live and dead fetuses were recorded.
HISTOPATHOLOGY / ORGAN WEIGHTS
- not examined - Statistics:
- Bartlett's test for homogeneity of variance (Bartlett, 1937) to compare data of control group to data of treated groups followed by by a one-way classification analysis of variance (ANOVA) (Snedecor and Cochran, 1957).
Comparision of group mean values by the multiple pairwise comparison procedure of Scheffe (1953) if ANOVA of homogeneous data were significant and by Games and Howell's multiple pairwise comparison procedure (1976) if ANOVA of heterogeneous data were significant.
Ovarian and uterine data were analyzed on a per litter basis using nonparametric comparision of group means (Kruskal and Wallis 1952, Miller 1966) - Historical control data:
- no
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Only pregnant females were examined
CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS)
Two animals of the low dose group died during treatment (at day 10 and day 12). Gross pathology findings indicate tracheal intubation as cause of death (see reference 2). There was no mortality at 500 or 1000 mg/kg bw and day.
Clinical signs were seen in one or two animals of all dose groups. A clear dose related effect is not evident.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
No statistically significant effects on body weight were noted. The rats dosed at 100 mg/kg bw showed a slight decrease in body weight from day 9 to day 12. For the 1000 mg/kg bw dose group, the mean body weight decreased from day 6 to day 9. There was no dose related effect.
GROSS PATHOLOGY (PARENTAL ANIMALS)
Gross pathology findings were observed in 2 animals of the 100 mg/kg bw dose group (affected organs: lung, kidney, stomach), in 1 animal of the 500 mg/kg bw dose group (affected organ: lung) and in 2 animals of the 1000 mg/kg bw dose group (affected organ: kidney). The observed effects were not dose related.
HISTOPATHOLOGY (PARENTAL ANIMALS)
Not examined
OTHER FINDINGS (PARENTAL ANIMALS) - OVARIAN AND UTERINE DATA
There were no significant effects on ovarian or uterine parameters. Mean ovarian and uterine data were comparable between the control and the treated groups except the mean percent resorption in the group dosed with 1000 mg/kg bw. The deviation was caused by one animal which had 100% resorption at its implantation sites.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:not examined
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Based on a transient body weight effect and gross pathology at 1000 mg/kg bw and no significant effect at 500 mg/kg bw, a dose of 750 mg/kg bw was selected as teratology screen dose (reference 2). |
Applicant's summary and conclusion
- Conclusions:
- The investigation of the maternal toxicity of n-valeric acid in pregnant rats did not show significant differences between control and treated groups.
Based on a transient body weight effect and gross pathology at 1000 mg/kg bw and no significant effect at 500 mg/kg bw, a dose of 750 mg/kg bw was selected as teratology screen dose. - Executive summary:
A maternal tolerance study was performed with n-valeric acid in order to determine dose levels for a subsequent teratology screening study. N-valeric acid was administered to pregnant female Sprague-Dawley rats, 6 animals per dose, by gavage at dose levels of 0, 100, 500, and 1000 mg/kg bw. Animals were treated daily from day 6 to day 15 of gestation. At day 16 of gestation, animals were sacrificed and mortality, clinical signs, body weight, food consumption, water consumption, gross pathology, and ovarian and uterine parameters were evaluated.
The observed data did not demonstrate significant differences between control and treated groups. A dose related effect was not observed.
A NOAEL was not determined.
Based on a transient body weight effect and gross pathology at 1000 mg/kg bw and no significant effects at 500 mg/kg bw, a dose of 750 mg/kg bw was selected as teratology screening dose.
The study procedure did not follow a valid test guideline but may be regraded as a range finding study.
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