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EC number: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
- 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
- Remarks:
- other: Repeat dose study with histopathology of reproductive organs.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.
Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.
Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 022
- Reference Type:
- publication
- Title:
- Exhibit II.
- Author:
- Scientific Associates, Inc.
- Year:
- 1 966
- Bibliographic source:
- Final report on thirteen-week subacute feeding of Alfol 6 and Alfol 16 to rats.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Rats treated via the diet for 90 days with limited evaluation, but including reproductive organs.
Groups of 20 rats (10 of each sex) were fed Alfol 16 in the diet for 13 weeks. The control group consisted of 20 males and 20 females at dose levels of 1, 2.5 and 5% with the top dose level increasing at week 11 to 7.5% and for weeks 12& 13 to 10% in the diet. At termination, all animals were necropsied and tissues from 5 males and 5 females (including gonads) of the high dose group and a similar number of controls were examined histopathologically. Testes and ovary weights were recorded together with other organ weights. - GLP compliance:
- not specified
- Remarks:
- Pre-dates widespread introduction of GLP
- Limit test:
- no
Test material
- Reference substance name:
- Hexadecan-1-ol
- EC Number:
- 253-149-0
- EC Name:
- Hexadecan-1-ol
- Cas Number:
- 36653-82-4
- Molecular formula:
- C16H34O
- IUPAC Name:
- hexadecan-1-ol
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report): Alfol 16 (tradename)
- Substance type: white, waxlike solid, with an odour similar to coconut oil
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 624-6537 and 624-6539 from the Continental Oil Company, USA
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino Charles river
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc.
- Age at study initiation: no data but "young"
- Weight at study initiation: males 104.1 g, females 90.5 g
- Fasting period before study: no data
- Housing: individually in suspended wire-mesh cages
- Use of restrainers for preventing ingestion (if dermal): not applicable
- Diet (e.g. ad libitum): Purina Laboratory Chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data but "controlled within narrow limits"
- Humidity (%): no data but "controlled within narrow limits"
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): basal laboratory diet (Purina Laboratory Chow)
- Storage temperature of food: no data - Details on mating procedure:
- no mating - screening study
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Exposure period: 13 weeks
Duration of test: 13 weeks - Frequency of treatment:
- continuous in diet
- Details on study schedule:
- no mating - screening study
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 5 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 2.5 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 1 other: %
- Remarks:
- nominal in diet
- No. of animals per sex per dose:
- 10 (treated), 20 (controls)
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): no data - Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: 5 days/week
- Cage side observations included: general physical appearance, gross signs of systemic toxicity and/or pharmacological effect, behaviour, mortality
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Time schedule for examinations: weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as mg/kg bw/day: Yes
WATER CONSUMPTION: No
OTHER: Haematology and urinalysis (reported elsewhere) - Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- Parameters examined in males: testis weight
- Litter observations:
- no litters - no mating - screening study
- Postmortem examinations (parental animals):
- SACRIFICE
- Males: All surviving animals, after 13 weeks of treatment
- Females: All surviving animals after 13 weeks of treatment
GROSS NECROPSY
- Gross necropsy included external and internal examinations of the cervical, thoracic, and abdominal viscera
ORGAN WEIGHTS: brain, thyroid, heart, liver, spleen, kidneys, adrenals, gonads (testes or ovaries)
HISTOPATHOLOGY: Yes
- brain, thyroid, parathyroid, heart, lung, liver, spleen, stomach, small intestine, large intestine, pancreas, kidney, urinary bladder, adrenal, gonads (testes or ovaries), lymph node, bone, bone marrow
- all listed tissues from 5/sex from high dose and controls examined - Postmortem examinations (offspring):
- no offspring - no mating - screening study
- Statistics:
- Chi-squared test for comparing relative organ weights. Original organ weight analyses using the Chi square test were supplemented by Tukey tests carried out by the Weinberg group (see 'Any other information on materials and methods')
- Reproductive indices:
- no mating - screening study
- Offspring viability indices:
- no offspring - no mating - screening study
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- 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:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
- none of the animals displayed overt signs of intoxication due to oral exposure to hexadecanol during the 13 weeks of the experiment.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
- food consumption and body weights differed significantly for both males and females at various times in the intermediate and high dose levels.
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
- animals in the low, mid and high dose groups were administered dietary concentration of 1%, 2.5% and 5-10% respectively
- average compound intake for males, calculated from weekly food consumption data, was 723, 1822 and 4257 mg/kg bw/day respectively
- average compound intake for females, calculated from weekly food consumption data, was 875, 2064 and 4567 mg/kg bw/day respectively
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
- not examined
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
- not examined
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
- not examined
ORGAN WEIGHTS (PARENTAL ANIMALS)
- the relative testes weights were increased over control levels in all treatment groups reaching signficance in the low and high dose group according to the study report. The organ weight data were reanalysed by the Weinberg Associates using a Tukey test when significance was attained only at the high dose level (see 'Remarks on results' section)
- there were no significant changes in ovary weight
GROSS PATHOLOGY (PARENTAL ANIMALS)
- no effects
HISTOPATHOLOGY (PARENTAL ANIMALS)
- histopathological examination revealed no treatment-related changes in the ovaries or testes.
OTHER FINDINGS (PARENTAL ANIMALS)
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 822 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 4 567 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
Details on results (F1)
Effect levels (F1)
- Generation:
- F1
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: no offspring - no mating - screening study
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Gonad weight mean relative:
|
Control |
Low |
Mid |
High |
Males |
0.793 |
0.768* |
0.787 |
0.902*+ |
SD |
0.062 |
0.003 |
0.084 |
0.052 |
*Significant using Chi square test as reported in original report. +Significant in Tukey test.
Applicant's summary and conclusion
- Conclusions:
- In a reliable screening study, a repeated oral dose NOAEL of 1822 mg/kg/day for males and 4567 mg/kg/day (the highest dose tested) in females was determined for effects on reproductive organs in the rat.
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