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EC number: 941-187-7 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 29 May 1998 to 26 June 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. The original study was reliability 1. Read across to the registered substance is considered scientifically justified and reliabiltiy 2.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- (no functional observations; limited pathological examination)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C10-16
- EC Number:
- 267-019-6
- EC Name:
- Alcohols, C10-16
- Cas Number:
- 67762-41-8
- IUPAC Name:
- tetradecan-1-ol
- Details on test material:
-
- Name of test material (as cited in study report): Compound 33A (Safol 23). Equivalent to Alcohols, C12-13-branched and linear (CAS 740817-83-8).
- Substance type: technical product
- Physical state: colourless liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: mixture of C12-C13 alcohols
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: KPT/SAS/DA/2/98
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable in the vehicle (corn oil) when stored at 2-10oC for 7 days
- Storage condition of test material: in refrigerator
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 5 weeks
- Weight at study initiation: males, 144.2-171.6 g (mean 159.3 g); females, 114.4-134.8 g (124.7 g)
- Fasting period before study: no data
- Housing: in groups of 5 in stainless steel cages with mesh floors
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-25.0
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29-May-1998 To: 26-Jun-1998
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: prepared in corn oil; concentration adjusted to give a constant dosing volume of 5 ml/kg bw. Twice per week the dose volumes were adjusted to the latest body weight of each individual animal. Fresh dosing solutions were prepared weekly.
VEHICLE
- Justification for use and choice of vehicle (if other than water): no data
- Concentration in vehicle: 0, 20, 60 or 200 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations of the test material in corn oil were analysed using a Perkin Elmer 8700 gas chromatograph with flame ionisation detection on day of preparation and after 7 days storage in a refrigerator.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily (7 days/week)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 or 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on a 7-day range-finding study
- Rationale for animal assignment (if not random): animals were weighed of first day of treatment and allocated to the various groups proportionally to weight class by a computer randomization program - Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily (once daily at weekends)
- Cage side observations included: all abnormalities, signs of ill health and reactions to treatment
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 4, 11, 14, 18, 21, 25, 27 and 28
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at study termination on day 28
- Anaesthetic used for blood collection: Yes, ether
- Animals fasted: Yes
- How many animals: all groups
- Parameters examined: haemoglobin, packed cell volume, red blood cell count, reticulocytes, total white blood cell count, differential white blood cell count, prothrombin time, thrombocyte count. Mean corpuscular volume, mean corpuscular haemoglobin and mean corpuscular haemoglobin concentration were calculated.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at study termination on day 28
- Animals fasted: Yes
- How many animals: all groups
- Parameters examined: alkaline phosphatase (ALP), aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma glutamyl transferase (GGT), total protein, albumin , albumin/globulin ratio, urea, creatinine, fasting glucose, bilirubin, cholesterol, triglycerides, phospholipids, calcium, sodium, chloride, inorganic phosphate
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. Full necropsy performed. Due to some difficulties during dosing it was decided to remove, examine and sample the oesophagus from all animals. However these samples were not processed for histopathological examination.
- Organ weights: adrenals, brain, kidneys, liver, spleen, testes
HISTOPATHOLOGY: Yes. Adrenals, heart, kidneys, liver, spleen, testes and gross lesions from all control and high dose animals. - Statistics:
- Body weights: one-way analysis of covariance (covariate body wt day 0) followed by Dunnetts multiple comparision tests
Food consumption: no statistics
Haematological parameters: one-way analysis of covariance (ANOVA) followed by Dunnetts multiple comparision tests.
Differential WBC: Kruskal-Wallis non-parametric ANOVA followed by Mann-Whitney U-tests.
Histopathology: Fishers exact probability test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
At the high-dose most males (80%) and all females showed thinly haired areas of skin (probably due to hair nibbling). 3/5 high-dose males showed weakness, thin appearance and respiratory disorders, one of these died on day 27, probably due to faulty dosing. High-dose animals in particular showed some resistance to dosing. A few rats regurgitated the test material immediately after dosing. No other clinical signs were attributed to the test material.
BODY WEIGHT AND WEIGHT GAIN
The high-dose males showed a reduction in mean body weight which reached statistical significance in the first and last weeks of the study (p<0.05). On day 27 the mean body weight of the control males was 269 g while the mean body weight of the high-dose males was 232 g.
FOOD CONSUMPTION AND COMPOUND INTAKE
Food consumption was decreased in the high-dose males compared to the controls [control 17.3 g/rat per day; high-dose 14.4 g/rat per day].
FOOD EFFICIENCY
Food efficiency was decreased in the high-dose males compared to the controls [control mean 0.23 g wt gain/g food consumed; high-dose 0.17 g wt gain/g food consumed, the value for week 4 in the high-dose group was -0.01 g wt gain/g food consumed].
HAEMATOLOGY
High-dose females: thrombocyte count was significantly reduced [control 1185 x 10E9/l; high-dose 1066 x 10E9/l (p<0.01)] and the absolute number of monocytes was increased [control 0 x 10E9/l; treated 0.04 x 10E9/l (p<0.05)].
Mid-dose males: mean corpuscular haemoglobin was significantly reduced [control 1.34 fmol; test 1.26 fmol (p<0.05)]. [The investigators considered this to be "fortuitous" presumably because of the lack of effect at the high dose.]
No other changes were evident.
CLINICAL CHEMISTRY
Significant increases in high-dose females for plasma ALP [control mean 101 U/l; high dose 150 U/l p<0.05], ALAT [control mean 27 U/l; high-dose mean 39 U/l (p<0.05)] and cholesterol [control mean 1.73 mmol/l; high-dose mean 2.21 mmol/l (p<0.01)]. A reduction in the albumin/globulin ratio was seen in high dose males [control mean ratio 1.05, high-dose mean ratio 0.88 (p<0.05)]. There were no other differences between the groups for the parameters analysed.
ORGAN WEIGHTS
There was a dose-related statistically significant increase in relative kidney weight in mid- and high-dose males [controls 6.80 g/kg bw; low-dose 7.15 g/kg bw; mid-dose 7.31 g/kg bw (p<0.05); high-dose 7.80 g/kg bw (p<0.01)]. Absolute kidney weights showed no significant change from controls. There were no other significant changes in absolute or relative organ weights.
GROSS PATHOLOGY
Pathological changes in two high-dose males (hydrothorax & spotted lungs in the animal which died) and a grossly abnormal thoracic cavity filled with fibrin in another male were considered by the investigators to have been associated with the dosing procedure .
HISTOPATHOLOGY: NON-NEOPLASTIC
Pleuritis and severe haemorrhage of the lungs were present in the rat that died before study termination, suggesting that the test material had come into contact with the lungs during dosing. In the two other high-dose males showing clinical signs of distress, there was evidence of pericarditis in one animal and pericarditis with myocarditis and inflammation of the thoracic wall muscles was observed in the other. These changes were attributed to the administration procedure. There were no other treatment-related histopathological changes.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: kidney weight increased in males at 300 and 1000 mg/kg bw/day, but no accompanying clinical chemistry or pathological findings
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a reliable study, conducted to OECD guideline 407, an NOAEL of 300 mg/kg bw/day was established for Compound 33A (a mixture of C12-C13 alcohols). The study was performed in compliance with GLP.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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