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EC number: 203-931-2 | CAS number: 112-05-0
- 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:
- key study
- Study period:
- 11 May 1982 to 24 June 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- : minor deviations and some deficiencies in data reporting
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
- Details on test material:
- - Name of test material (as cited in study report): C-182 (nonanoic acid)
- Purity: > 96% (see attached document)
- Substance type: clear colourless liquid
- Physical state: liquid
- 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. New York
- Age at study initiation: about 14 weeks
- Weight at study initiation: 230.5 +/-17.9 g
- Housing: individually, 2 females per male during mating
- Diet (ad libitum): Purina Rodent Laboratory chow
- Water (ad libitum): tap water
- Acclimation period: about 9 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24.4 +/- 0.5
- Humidity (%): 57 +/- 4.8
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The amount of compound required was weighed and diluted with vehicle, dosing was performed from stirred dilutions
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/2
- Length of cohabitation: maximum of three weeks
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- gd 6 - 15
- Frequency of treatment:
- 1x/d
- Duration of test:
- 9 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1500 mg/kg bw/day in corn oil
Basis:
nominal conc.
- No. of animals per sex per dose:
- 22
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Administered dose was based on individual body weights from the most recent weighing interval and approximately the same time each day.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once daily
BODY WEIGHT: Yes
- Time schedule for examinations: on days 0, 6, 9, 12, 15 and 50 of gestation
FOOD AND WATER CONSUMPTION. Yes
- Time schedule for examinations: on days 6-8, 9-11, 12-14, 15-17, 18-20
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: gross examination of all internal organs, detailed examination of ovaries (see below) - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: about one-third per litter
- Skeletal examinations: Yes: about two-third per litter
- Head examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data
- Body weights and crown-rump distance: Yes - Statistics:
- The following statistic tools were used:
National Cancer Institute Package; Box's test for homogeneity of variance, followed by one-way ANOVA and Dunnett's T-test; test of multiple proportions; Fisher's exact test - Indices:
- Mean incidence of visceral anomalies: group mean of [(number fo fetuses with anomalies per litter/number of fetuses examined viscerally per litter) x 100]
Mean incidence of visceral variants: group mean of [(number fo fetuses with variants per litter/number of fetuses examined viscerally per litter) x 100]
Mean incidence of skeletal anomalies: group mean of [(number fo fetuses with anomalies per litter/number of fetuses examined viscerally per litter) x 100]
Mean incidence of skeletal variants: group mean of [(number fo fetuses with variants per litter/number of fetuses examined viscerally per litter) x 100]
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
There were no compound-related maternal effects (body weight gain, food and water consumption, gross pathology).
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Skeletal variants and delayed ossification (both 38.2%) were identical to the values of the control group (38.2%). No statistically significant compound-related skeletal anomalies were noted: Of a selection of 80 fetuses from 22 litters, there were two instances of cleft palate, two with small tongue, and a single incidence of hydroureter that were not seen in control fetuses.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Summarised results (maternal body
weights, ovarian, uterine and litter data, fetal examinations) are
presented in the attached document.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this developmental study there were no effects with respect to dams or offspring.
- Executive summary:
22 female Sprague-Dawley rats were treated orally by gavage with 1500 mg/kg bw/day of the test item on days 6 -15 of gestation in a developmental toxicity test. The 22 control animals received the vehicle corn oil. After the sacrifice at day 20 of gestation no adverse effects could be observed in the exposed dams. There were no differences between the offspring of treated and control rats with respect to teratogenic or fetotoxic effects (resorptions, viability, fetal weights, skeletal or visceral malformations or variations). Therefore the NOAEL of this study is 1500 mg/kg bw/day for dams and offspring (Celanese/Hazleton, 1983).
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