Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-008-8 | CAS number: 505-32-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed data, available as short summary from secondary source, reliability according to HPV/ICCA SIDS.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 998
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:
- 14 day recovery group
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- EC Number:
- 208-008-8
- EC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Cas Number:
- 505-32-8
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Cr1:CD(SD)BR (VAF plus)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK, Margate, UK
- Age at study initiation: approximately 28 days old at arrival
- Weight at study initiation: males 154-186 g and females 122-164 g
- Housing: groups of six per sex in grid-bottomed stainless-steel cages (TR18, Modular Systems, Kent, UK), suspended over cardboard-lined litter trays.
- Diet (e.g. ad libitum): SQC Rat and Mouse Maintenance Diet No. 1, Expanded (Special Diets Services, Whitham, UK) ad libidum
- Water (e.g. ad libitum): tap water ad libidum
- Acclimation period: 13 days prior to the start of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 36 to 49%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Separate formulations were prepared daily for each dose level.
VEHICLE
- Amount of vehicle (if gavage): 50 ml solution/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- As a confirmation of concentrations, samples of each formulation including the vehicle only control prepared on day 1 of weeks 1 and 4 of dosing were sent to the sponsor and analysed.
- Duration of treatment / exposure:
- 28 consecutive days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000
Basis:
actual ingested
- No. of animals per sex per dose:
- 12 (control, 1000 mg/kg bw/day group)
6 (250, 500 mg/kg bw/day group) - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily for mortality and morbidity.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All visible signs (including behavioural) of reaction to treatment were recorded daily.
BODY WEIGHT: Yes
- Time schedule for examinations: start of the study and then twice weekly up to the day of necropsy.
FOOD CONSUMPTION:
The amount of food consumed by each cage of animals was recorded weekly throughout the treatment and treatment-free periods
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: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: from the first 6 males and females in each group during week 4 of treatment. Further samples were taken from the remaining animals towards the end of week 2 of the treatment-free period.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: from the first 6 males and females in each group during week 4 of treatment. Further samples were taken from the remaining animals towards the end of week 2 of the treatment-free period.
- Animals fasted: No data
URINALYSIS: Yes
- Time schedule for collection of urine:from the first 6 males and females in each group during week 4 of treatment. Further samples were taken from the remaining animals towards the end of week 2 of the treatment-free period.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
At the end of the treatment and treatment-free period, the respective animals were killed by CO2 asphyxiation. Dissections were completed in two days respectively one day for the remaining treatment-free animals. All animals were weighed, examined externally, the abdominal cavity opened, exsanguinated, macroscopically examined and the following selected organs excised and weighed: adrenals, brain, epididymides, heart, kidneys, liver, ovaries, spleen, testes, thymus. Tissue samples were taken and fixed for histology from 22 organs and sites, including all gross lesions. - Statistics:
- Sexes were analysed separately. Observations included bodyweights, bodyweight gains over the treatment period, food consumption, absolute and relative organ weights as well as clinical pathology data. The data were subjected to ANOVA. If between-group differences in variance were detected, pairwise tests versus controls were performed using Williams' test. Statistical significance was declared at two-sided 5% level and also noted at 1% and 0.1% levels. Haematological, biochemical and urinalytical results were analysed non-parametrically.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
There were no mortalities during this study. Fur-staining was recorded in a number of females given 1000 mg/kg bw/d. One female from this group also showed hypoactivity, hunched posture, weight loss and pallor. These signs were considered related to the treatment. All other signs noted were considered not to be related to the treatment.
BODY WEIGHT AND WEIGHT GAIN
Both bodyweights and bodyweight gains were normal for rats of this age and strain in all four groups.
FOOD CONSUMPTION
There were no obvious treatment-related effects on food consumption.
HAEMATOLOGY
At the end of the 4-week treatment, increased white blood cell (WBC) count was noted for the high-dose females. In the high-dose males the group mean prothrombin time was slightly reduced. At the end of the treatment-free period, the WBC count in females remained marginally higher than in controls but fell within the quoted background ranges and was considered to have recovered. The prothrombin time in males was comparable with controls.
CLINICAL CHEMISTRY
Small but statistically significant increases in alanine aminotransferase (ALT) were observed in mid-dose males and in both sexes at high dosage. Groups mean cholesterol levels in females demonstrated an apparent dose-related increase. Calcium levels were also elevated in low-dose females and in both sexes at mid and high dose. At the end of the treatment-free period there were no significant differences from controls regarding those parameters reexamined.
URINALYSIS
After 4 weeks of treatment urine volumes were increased, with a corresponding decrease in specific gravity, in mid-dose males and in both sexes at high dosage. At the end of the treatment-free period the group mean urine volume in both sexes at high dosage was higher than in associated controls, again with a corresponding decrease in specific gravity.
ORGAN WEIGHTS
Absolute and relative liver weights were increased in both sexes at a dose of 1000 mg/kg bw/d. Absolute kidney weights were increased in females at all dose levels, although when related to bodyweight this increase was only significant at the high dose. Absolute spleen weights were increased in both sexes in all dose groups; when related to bodyweight, spleen mass showed an increase for females only at the high dose. The dead bodyweights of males from treated groups were significantly higher than controls, which was considered to be the reason for the apparent increased absolute spleen weights and also a reduction in bodyweight-related brain weights seen in both sexes at high dose. At the end of the treatment-free period the liver weights of females had dropped to significantly below the comparable control levels. The liver weights of males from the high-dose group had regained levels similar to controls. Other, minor changes noted were considered not to be related to treatment.
GROSS PATHOLOGY
No obvious treatment-related abnormalities were observed at dissection.
HISTOPATHOLOGY
No treatment-related effects were recorded during histopathology. A small number of findings were within the normal range of background alterations for untreated rats of this strain and age and were considered not to be related to treatment.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
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.