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EC number: 248-471-3 | CAS number: 27458-94-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline (414): GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Differential prenatal toxicity of one straight-chain and five branched-chain primary alcohols in rats
- Author:
- J. Hellwig and R. Jackh
- Year:
- 1 997
- Bibliographic source:
- Food and Chemical Toxicology. 35:489-500
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- only 10 animals used per group
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isononyl alcohol
- EC Number:
- 248-471-3
- EC Name:
- Isononyl alcohol
- Cas Number:
- 27458-94-2
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): isononanol type 1 and type 2
- Physical state: liquid
- 2 different isononanols were used, referred to as type 1 and type 2
Type 1 consisted of roughly equivalent amounts of 3,4-, 4,6-, 3,6-, 3,5-, 4,5- and 5,6-dimethylheptanol-1.
Type 2 consisted of 4,5-dimethylheptanol-1, 4-methyloctanol-1, 3-ethylheptanol-1, 6-methyloctanol-1, and 3-ethyl-4-methylhexanol-1.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 68-85 days old
- Weight at study initiation: 214-233 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Chemicals were freshly prepared for gavage administration every day in aqueous emulsions under rapid stirring in double-distilled water containing approximately 0.005% Cremophor EL as an emulsifier - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/4
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnany - Duration of treatment / exposure:
- From day 6 to day 15 post conception
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 158, 790, 1580
Basis:
analytical conc.
mg/kg/day isodecanol
- Remarks:
- Doses / Concentrations:
0, 144, 720, 1440
Basis:
analytical conc.
mg/kg/day isononanol type 1
- Remarks:
- Doses / Concentrations:
0, 130, 650, 1080
Basis:
analytical conc.
mg/kg/day isononanol type 2
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: study termination
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- weight of uterus before opening
- number of corpora lutea
- number of implantations
- live fetuses
- dead implantations
- early resorptions
- late resorptions
- dead fetuses - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes: /half per litter
- Head examinations: Yes: - Statistics:
- Dunnett’s test and Fisher’s exact test were used for evaluating data.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal effects generally included decreased body weight gain, apathy, nasal discharge, and signs of CNS depression.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Remarks:
- isononanol type 1
- Effect level:
- 720 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Remarks:
- isononanol type 1
- Effect level:
- 720 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Remarks:
- isononanol type 2
- Effect level:
- 650 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Remarks:
- isononanol type 2
- Effect level:
- 650 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Embryotoxicty was not examined in this study.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
In this study, isononanol type 1 (consisting of isomers with a moderate degree of branching (dimethyl heptanols) and approximately 16% isodecanol), isononanol type 2 (consisting of isomers with a low degree of branching (dimethyl heptanols and methyl octanols), were evaluated for their potential to induce developmental toxicity. All chemicals were orally administered daily to pregnant dams during gestation day 6 through 15.
Isononanol type 1 (0, 144, 720, or 1440 mg/kg/day) at the highest dose was lethal for all 10 dams. At 720 mg/kg bw/day effects on the dams consisted of unsteady gait, nasal discharge, initially reduced food consumption and effects on body weight parameter including retarded body weight gain during treatment. No effects on the fetus were observed at this dose.
Isononanol type 2 (0, 130, 650, 1080 mg/kg/day) was lethal for 3 dams at 1440 mg/kg bw/day. Further marked effects consisted of impaired state of health including abdominal or lateral position, unsteady gait and apathy, reduced food consumption, effects on body weight parameters including body weight losses. At 650 mg/kg bw/day, there were no statistically significant effects on the fetus.
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