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EC number: 233-126-1 | CAS number: 10042-59-8
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study (OECD) (No specific fertility study but treatment long enough to cover sperm maturation (no mating performed).)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 408 (Subchronic Oral Toxicity - Rodent: 90-day study, May 12, 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- 2-propylheptan-1-ol
- EC Number:
- 233-126-1
- EC Name:
- 2-propylheptan-1-ol
- Cas Number:
- 10042-59-8
- Molecular formula:
- C10H22O
- IUPAC Name:
- 2-propylheptan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Propylheptanol
- Analytical purity: 99.5% (GC)
- Lot/batch No.: CIW/E, Reg. No. 20 595
- Test substance No.: 94/279
- Stability under test conditions: by reanalysis after the in-life phase of the study; the stability of the test substance in the vehicle over a period of 3 hours was proven before the start of the study (as the emulsions were prepared daily and administered within this time period, the stability was guaranteed)
- Homogeneity: proven by visual inspection
- Storage condition of test material: room temperature; protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Germany
- Age at study initiation: 42 days
- Weight at study initiation: the body weight of the males was in the range of 100 - 124 g (group mean: 110 g) and the body weight of the females was in the range of 85 - 101 g (group mean: 94 g)
- Housing: single
- Diet: ground Kliba maintenance diet rat/mouse/hamster, 343 meal, supplied by Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: drinking water (from water bottles) were available ad libitum
- Acclimation period: 6 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:
- other: Cremophor EL(R) in bi-distilled water (approximately 5 mg/100 ml)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
To prepare the emulsion, Propylheptanol was weighed depending on the dose group, then the vehicle was filled up to the desired volume and subsequently mixed using an Ultra Turrax. During administration to the animals the test substance preparations were kept homogeneous with a magnetic stirrer. The test substance preparations were prepared daily.
The administration volume was 10 ml/kg body weight, based upon the latest individual body weight determination. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- At the beginning of the administration period the homogeneity of the test substance in the vehicle was checked at the low and high concentration; these analyses served also as concentration controls. Further concentration control analyses were carried out in samples from the mid dose drawn at the beginning of the administration period, and in samples from all doses drawn at the end of the administration period. Analytical checks of the concentrations revealed 89% - and 103% of the target concentrations. Although one value was only 89% of the target concentration (high dose at termination of the study), this was assessed as being acceptable.
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- daily
- Duration of test:
- 3 months
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 150, 600 mg/kg bw/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- other: yes, group #1: bi-distilled water, group #2: emulsifier (double distilled water with approx. 0.005% Cremophor EL)
- Details on study design:
- - Dose selection rationale:
Based upon the findings in a prenatal toxicity screening study with Propylheptanol (1580, 790 and 158 mg/kg body) the following doses were selected for the present study: 600 mg/kg body weight (as high dose with expected effects on body weight), 150 mg/kg body weight (as mid dose), 30 mg/kg body weight (as low dose) - Statistics:
- Means and standard deviations of each test group were calculated. As two control groups were used in this study (groups 0 and 1), comparison was performed using either group 0 as the reference control group (with which groups 1 to 4 were compared) or group 1 was taken as the reference control group (with which groups 2 to 4 were compared).
Food consumption, body weight, body weight change, food efficiency: Parametric one-way analysis using the F-test (ANOVA) (two-sided). If the resulting p-value was equal or less 0.05, a comparison of each group with the control group using the DUNNETT's test (two-sided) was performed for the hypothesis of equal means.
Clinical pathology parameters, except differential blood count: Parametric one-way analysis using the F-test (ANOVA) (two-sided). If the resulting p-value was equal or less 0.05, a comparison of each group with the control group was performed using DUNNETT's tes (two-sided) for the hypothesis of equal means.
Urinalysis, except volume, color and turbidity: Pairwise comparison of each dose group with the control group using FISHER's exact test for the hypothesis of equal proportions.
Weight parameters: A comparison of each group with the control group using the DUNNETT's test (two-sided) was performed for the hypothesis of equal means.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- disregarding peroxisomal proliferation
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- other: LOAEL disregarding peroxisomal proliferation
- Effect level:
- 600 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: human hazard: impairment of food consumption/body weight/body weight change/terminal body weight, hematology, clinical chemistry, increase in squamous epithelial cells in the urine, histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/L air (nominal)
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: effects due to peroxisomal proliferation: increased mean relative liver weight, diffuse hypertrophy of the liver cells at 150 mg/kg bw
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LOAEL
- Effect level:
- 600 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: impairment of food consumption/body weight parameters, hematology, clinical chemistry, urinalysis at 600 mg/kg bw, no effects on reproductive parameters; effects on liver due to peroxisomal proliferation
Observed effects
Substance-related effects were seen at 600 mg/kg in both sexes and at 150 mg/kg in females, only. Main target organ was the liver, most probably related to a peroxisome proliferating potential of the test substance.
Applicant's summary and conclusion
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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