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EC number: 240-714-1 | CAS number: 16669-27-5
- 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
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guidelines for Detection of Toxicity to Reproduction for Medicinal Products
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- A fertility and reproduction study in rats administered a maximum dose of 1000 mg/kg bw/day Docosan-1-ol was conducted.
- GLP compliance:
- yes
- Remarks:
- Huntingdon Life Sciences Ltd (Suffolk, England)
- Limit test:
- no
Test material
- Reference substance name:
- Docosan-1-ol
- EC Number:
- 211-546-6
- EC Name:
- Docosan-1-ol
- Cas Number:
- 661-19-8
- Molecular formula:
- C22H46O
- IUPAC Name:
- docosan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited (Margate,Kent, England)
- Age at study initiation: (P) males: 6 to 7 weeks; females: 10 to 11 weeks
- Weight at study initiation: (P) Males:193 and 240 g; Females: 208 and 262 g;
- Housing: TR18 stainless-steel cage (Modular Systems and Developments Company Limited, Hereford, England); during mating period, 1 male and 1 female were
housed in a RB3-modified high-grade polypropylene cage with stainless-steel mesh lids and floors (North Kent Plastic Cages Limited, Erith, Kent, England).
- Diet: ad libitum, expanded rodent diet (Special Diets Services Ltd., Witham, Essex, England) containing no added antibiotic, or other chemotherapeutic
or prophylactic agent
- Water: ad libitum, tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 55%
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/w Tween 80
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Whe required amount of behenyl alcohol was weighed into a glass container and heated (approximately 80°C) until molten using an electric mantle.
An appropriate volume of vehicle (1% Tween 80) was heated in a water bath to at least 75°C and then combined with the molten behenyl alcohol under continuous magnetic stirring, to a concentration of 20% behenyl alcohol. The resulting suspension was slowly cooled, with homogenization to a temperature of below 60°C, and then further cooled in a water bath to a temperature of 30°C. The 20% behenyl alcohol suspension was prepared weekly.
The lower concentrations were prepared on the day of use by dilution of the 20% suspension with 1% w/w aqueous Tween 80.
VEHICLE
- aqueous Tween 80
- Amount of vehicle (if gavage): 1%
Animals received the test material or vehicle control formulations by gavage, at volume-dosage of 5 mL/kg bw, using an 8 or 10 choke rubber catheter. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The composition and stability of behenyl alcohol were documented throughout the study.
- Duration of treatment / exposure:
- Males were treated with Behenyl alcohol daily for 71 days prior to mating, during mating, and until termination. Females were treated with the test
substance for 15 days prior to mating, during mating, and up to Day 17 of gestation.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 10 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 44 (22 males and 22 females)
- Control animals:
- yes, concurrent vehicle
- Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly (males), on Gestation Days 0, 3, 7, 10, 14, 18, and 20 (females)
FOOD CONSUMPTION AND COMPOUND INTAKE:
Prior to mating,food and water consumption for males and females was recorded weekly and daily, respectively. During the gestation
period, food and water consumption was measured only for females during the following time periods: Gestation Days 0 to 2, 3 to 6, 7 to 9,
10 to 13, 14 to 17, and 18 to 19, inclusive.
- Oestrous cyclicity (parental animals):
- 10 days before the mating period began, vaginal smear samples were obtained daily from all females to assess the regularity, as well as the duration of estrous
cycles. - Sperm parameters (parental animals):
- The left vas deferens was ligated to obtain a 5 μL sample from the cauda epididymis to assess for motility according to the following grades:
no sperm motile; few sperm motile; most sperm motile, slow moving; or most sperm motile, fast moving. - Postmortem examinations (parental animals):
- Females:
- killed on Day 20 of gestation by carbon dioxide inhalation, and uterine contents examined
- each female macroscopically examined for evidence of disease or adverse reaction
- number of corpora lutea in each ovary counted
- reproductive tract, including ovaries dissected out
- for each female, the numbers of pre- and post-implantation sites, early and late resorption sites, and viable fetuses, as well as the distribution of fetuses in each uterine horn, examined
- uterus of any female presumed to be nonpregnant was stained using 10% aq (v/v) ammonium sulfide solution and examined for implantation sites
Males:
- reproductive organs weighed - Postmortem examinations (offspring):
- - each fetus weighed, subjected to detailed external examination
- placental weights were recorded and examined macroscopically for any abnormalities
- neck, thoracic, and abdominal cavities were removed from half of the fetuses, the contents of the thoracic and abdominal cavities were examined, and sex was recorded
- fetuses subjected to a skeletal examination - Statistics:
- To test the statistical significance of suggestive intergroup differences, one-way analysis of variance and t test were performed on body weights, body weight
changes, and food and water consumption. Organ weights were evaluated by Dunnett’s or Behren’s-Fisher’s tests. Nested analysis of variance and weighed
t test were conducted on fetal and placental weights. Differences with an associated probability of P<0.05 were deemed to be statistically significant.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- One male treated with 1000 mg/kg bw/day and demonstrating abdominal distension, pallor, ptosis, irregular respiration, and a decrease in body weight was killed during Week 6.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
- absolute and relative weights of reproductive organs similar between treatment groups and control group
- evaluation of sperm number and motility revealed no findings attributable to treatment
- placental weights were not affected by treatment
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Table 1: Mean Reproductive parameters of rats treated with Behenyl alcohol
Dose (mg behenyl alcohol/kg body weight) |
||||
0 | 10 | 100 | 1000 | |
Number of pregnant animals | 22 | 22 | 22 | 21 |
Corpora lutea count | 17.8 (2.7) | 18.4 (4.0) | 18.7 (2.3) | 18.9 (2.4) |
Implantations | 17.2 (2.6) | 17.0 (3.2) | 18.1 (1.8) | 18.0 (2.3) |
viable young male | 8.4 (2.9) | 8.4 (2.3) | 8.5 (2.5) | 8.6 (2.6) |
viable young female | 8.0 (3.0) | 7.5 (2.6) | 8.5 (2.2) | 8.3 (2.2) |
viable young total | 16.4 (3.2) | 15.9 (3.5) | 17.0 (2.3) | 16.9 (2.2) |
early resorptions | 0.82 (0.90) | 1.09 (1.04) | 1.14 (1.07) | 1.05 (1.02) |
late resorptions | 0.00 (0.00) | 0.0 (0.00) | 0.00 (0.00) | 0.00 (0.00) |
total resorptions | 0.82 (0.90) | 1.09 (1.04) | 1.14 (1.07) | 1.05 (1.02) |
Pre-Implantation loss (%) | 3.3 | 8.3 | 3.2 | 5.8 |
Post-Implantations loss (%) | 4.7 | 6.4 | 6.3 | 5.8 |
Numbers in parentheses represent standard deviations.
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.