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EC number: 204-017-6 | CAS number: 112-92-5
- 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
Endpoint summary
Administrative data
Description of key information
In the key study, no adverse effects were seen after dietary administration of a reliable 13 week oral feeding study in rats using hexadecan-1-ol reported a NOAEL value of >4400 mg/kg bw. (Scientific Assoc, 1966a; rel. 2) In addition read across from a reliable 28 day oral gavage study in rats using octadecan-1-ol reported a NOAEL value of >1000 mg/kg bw (Henkel, 1985a; rel. 2). A four week reliable oral study in rats using octadecan-1-ol reported a NOAEL value of 1000 mg/kg bw, the highest dose tested (Henkel, 1986a; rel. 1). A reliable 26 week oral gavage study in rats using docosan-1-ol reported no adverse effects at the highest dose tested, 1000 mg/kg bw (Iglesias et al., 2002a). Further supporting data come from a 90 day feeding study in rats with of Alcohols, C14-15-branched and linear (Ito et al., 1978) which reported a NOAEL value of >3548 mg/kg bw/day. A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Valid with restrictions including lack of biochemical investigations and limited reporting of statistical findings
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats treated via the diet for 90 days with limited evaluation
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: albino
- 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
- 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 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral 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 - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continuous in diet
- Dose / conc.:
- 1 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 2.5 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 5 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 7.5 other: %
- Remarks:
- nominal in diet
- Dose / conc.:
- 10 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
- Rationale for selecting satellite groups: no satellite groups - Positive control:
- none
- Observations and examinations performed and frequency:
- 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
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: days 30 and 90
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5/sex per group
- Parameters examined: microhaematocrit, haemoglobin, total and differential leukocyte count
CLINICAL CHEMISTRY: No
URINALYSIS: Yes
- Time schedule for collection of urine: days 30 and 90
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- How many animals: 5/sex per group (samples pooled)
- Parameters examined: albumin, acetone, bilirubin, colour, occult blood, sugar, pH, appearance, microscopic examination of sediment
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
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, gonad, lymph node, bone, bone marrow
- all listed tissues from 5/sex from high dose and controls examined - Other examinations:
- none
- 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')
- 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:
- 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:
- not examined
- Urinalysis findings:
- no effects observed
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- all animals survived the 13 week treatment period.
- all surviving animals appeared normal
BODY WEIGHT AND WEIGHT GAIN
- significantly reduced (84.7 - 89.8% of controls) in top dose males for most study weeks, in mid dose females at weeks 4-13 and high dose females (81.7-89.7%) throughout the study
- changes were attributed at least in part to reduced food consumption and the high content of test material in the diet.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
- significantly reduced (76.4 - 89.2% of controls) in top dose males at weeks 1 and 12, in mid dose males at week 13, in mid dose females at week 1 and high dose females weeks 1 and 12 (79.1 - 89.9% of controls).
FOOD EFFICIENCY
- no data
WATER CONSUMPTION
- not examined
OPHTHALMOSCOPIC EXAMINATION
- not examined
HAEMATOLOGY
- no effects
CLINICAL CHEMISTRY
- not examined
URINALYSIS
- no effects
NEUROBEHAVIOUR
- not examined
ORGAN WEIGHTS
- the original report indicated that there were significant differences in some relative organ weights from treated groups compared to controls. These were reanalysed by the Weinberg Group using the Tukey test (see 'Remarks on results' section)
GROSS PATHOLOGY
- unremarkable
HISTOPATHOLOGY: NON-NEOPLASTIC
- there were no treatment related histopathological changes in the control and top dose animals examined (including testes & ovaries).
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
- not applicable
HISTORICAL CONTROL DATA (if applicable)
- no data - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 4 257 other: mg/kg (bw) based on highest dose tested.
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No adverse effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 4 567 other: mg/kg (bw) based on highest dose tested.
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effects observed
- Critical effects observed:
- no
- Conclusions:
- In a reliable study, in which rats were treated with Alfol 16 via the diet for 13 weeks, an NOAEL of >4400 mg/kg bw/day (highest dose tested) was determined. Reduced weight gain, food consumption and organ weight changes were deemed to be secondary to the high dose administered but not specific to the test substance.
- Executive summary:
For hexadecan-1-ol, oral NOAELs were > 4257 and > 4567 mg/kg bw/day in male and female rats respectively in a 90-day repeated dose toxicity test in which a somewhat limited range of endpoints was evaluated (Scientific Associates 1966a).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 4 412 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read across data from the reliable 13 week repeat dose/reproductive oral feeding study in rats using structurally analogous hexadecan-1-ol (Scientific Associates 1966a) will be considered as the basis for classification for octadecan-1-ol. The key study was selected from data for substances with similar human health classification and physicochemical properties and therefore absorption properties to the registration substance. As no adverse systemic effects were observed for category members, the study using the highest dose from the available data was selected as key. A full discussion of the Category can be found in the Human Health Alcohols C6-24 Category report (PFA, 2016)..
In a 13-week study in rats hexadecan-1-ol (CAS 36653-82-4) was administered in the diet at concentrations of 0 (control), 1, 2.5 or 5- 10%; the level in the highest dose group being increased stepwise to 10% during the last 3 weeks of the study. Reductions in body weight gain (82-90% of control values) and food consumption (76 – 90% of control values) in the highest dose group and, occasionally, at the 2.5% level were the main findings of this study. Relative liver weights were increased in males at the top dose level (124% of control values) but in the absence of any microscopic findings the significance of this change is uncertain. A NOAEL was established to be equivalent to 4400 mg/kg/day (Scientific Assoc., 1966a).
Supporting data are available from a 28 day repeated dose oral study in which octadecan-1-ol was administered by oral gavage to male and female rats at 0, 100, 500, 1000 mg/kg bw/day (Henkel, 1986a). Statistically significant changes in some clinical chemical and haematological parameters and organ weights changes were not accompanied by histopathological changes and were either not dose related or appeared in only one sex. These effects are not considered of toxicological significance, so the NOAEL is considered to be >1000 mg/kg/day, the highest dose tested.
Further data for octadecan-1-ol comes from a combined repeated dose and reproductive/developmental screen feeding study in which octadecan-1-ol was tested in Wistar rats. Male animals were exposed for 37 days including the mating period, and no treatment-related histopathological changes were recorded. Clinical changes observed were without a dose response and are not considered to be adverse. The NOAEL was established to be 30 000ppm equivalent to 2000 mg/kg/day, the highest dose tested (Hansen, 1992b).
Docosan-1-ol (CAS 661-19-8) was administered daily to groups of rats at levels up to 1000 mg/kg for 26 weeks. Body weight and food consumption was not affected by treatment. Haematology, clinical chemistry and gross necropsy investigations showed no evidence of toxicity. There were no treatment related microscopic changes (Iglesias et al., 2002a).
In a 26 week oral gavage study docosan-1-ol (CAS 661-19-8; C22 alcohol) was administered daily to groups of dogs in levels up to 2000 mg/kg. Body weight and food consumption was not affected by treatment. Haematology, clinical chemistry and gross necropsy investigations showed no evidence of toxicity. There were no treatment related microscopic changes (Iglesias et al., 2002a).
The available repeated dose toxicity data for long chain alcohols have been reviewed and discussed, with the conclusion that the long chain alcohols are of low systemic toxicity (Veenstra G, Webb C et al., 2009).
Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:
In summary, the sub-category of the linear LCAAs is of a low order of toxicity upon repeated exposure. The LCAAs at lower end of this group caused local irritation at the site of first contact and induced signs of depression and respiratory effects when administered at very high dose levels and only as a bolus dose (C6, C8 alcohol) in the dog (C6 alcohol) and the rat (C8 alcohol). Other routes of exposure induced no apparent neurotoxicity either centrally or peripherally. Intermediate (>C8 to C12) and higher (>C12) linear LCAAs are non-irritant at the site of first contact and are without a neurotoxic potential. At high dose levels some of the higher LCAAs showed changes in clinical chemistry and liver weight but without further evidence of systemic toxicity; this finding may be indicative of mild, sub-clinical effects in the liver. There are no species differences observed for this sub-category, based on a comparison of the results of parallel studies in the rat and the dog.
In summary, the data for the essentially linear LCAAs, including the data from supporting substances, indicate a low order of toxicity upon repeated exposure. A consistent finding for this group is the effect on the liver: mild organ weight increases and/or slight clinical chemical changes but without evidence of significant histopathological effects. The clinical chemistry changes were generally of a slight grade but showed some inconsistencies, some of which relating to decreases in transferase activity, a change not normally associated with adverse hepatic effects. The (small) degree of the liver weight increases, the pattern of the clinical chemical changes and the absence of markers support the conclusion that this sub-category of LCAAs lacks a potential for the induction of peroxisomal proliferation. There is evidence of irritation at the first site of contact for the lower members of this group.
Conclusion:
The repeat dose toxicity of the category of LCAAs with chain lengths ranging from C6 to C22 indicates a low order of toxicity upon repeated exposure. NOAELs recorded for this category range between approx. 200 mg/kg/day to >4000 mg/kg/day in the rat upon sub-chronic administration via the diet. No adverse systemic effects have been seen in reliable studies with members of the Category of C6-24 Alcohols, therefore the NOAELs represent the highest dose tested. At the lower end, members of this category induce local irritation at the site of first contact. Other notable findings observed for several members within this group suggest mild changes consistent with low-grade liver effects with the changes in essentially linear LCAAs being slightly more pronounced than in linear alcohols. Typical findings include: slightly increased liver weight, in some cases accompanied by clinical chemical changes but generally without concurrent histopathological effects. Special studies demonstrated that this category does not have a potential for peroxisome proliferation. A potential for depression as observed for short chain aliphatic alcohols (C1 to C4; not included in this category) was also identified for hexan-1-ol and octan-1-ol, however this effect was only expressed upon repeated administration of a bolus dose; effects were absent upon inhalation or dietary administration. Similarly, hexan-1-ol and octan-1-ol induced respiratory distress upon repeated administration of a bolus dose. LCAAs do not have a potential for peripheral neuropathy. Furthermore, the data from the substances supporting this category (i.e. isoamyl alcohol), demonstrate that the toxicological profile of the repeated dose toxicity of 100% branched alcohols is qualitatively similar to that of the corresponding essentially linear alcohols. Chronic and sub-chronic toxicity studies have shown that LCAAs are of low toxicity. Furthermore, combined repeated-dose studies with developmental endpoints, as well as reproductive and developmental studies showed no effects at the highest dose tested. Where data gaps exist, the gap is filled by read-across from reliable evidence within the C6-24 Alcohols Category, where possible using interpolation between at least two reliable studies using higher and lower carbon number test substances.
Repeated dose toxicity data for the Category
|
CAS |
CHEMICAL NAME |
Species/ Study type/ Duration 1 |
Route |
NOAEL
(Ref) |
Rel. |
C5 |
123-51-3 |
Isoamyl alcohol (supporting) |
Rat 17 wk |
Gavage |
500 mg/kg |
2 |
C6 |
111-27-3 |
Hexan-1-ol |
Dog 13 wk |
Diet |
370 mg/kg |
2
|
C6 |
111-27-3 |
Hexan-1-ol |
Rat 13 wk |
Diet |
1127 mg/kg (Sc.Assoc.1966) |
2
|
C6 |
111-27-3 |
Hexan-1-ol |
Rat 3 wk |
Diet |
1000 mg/kg bw/day (Moody, 1978-1982) |
2 |
C6 |
111-27-3 |
Hexan-1-ol |
Rat subchronic 30 wk |
Intraperit oneal |
No peripheral neuropathy (Perbellini et al., 1978) |
2 |
C8 |
111-87-5 |
Octan-1-ol |
Rat |
gavage |
130 mg/kg (Hellwig, 1997) No systemic toxicity expected based on read across of a dermal study on Fatty Alcohol Blend of which octan-1-ol is a constituent, and on read-across from an oral study on hexan-1-ol. No adverse systemic effects were observed at the highest dose in either study. |
2 |
C9 |
143-08-8 |
Nonan-1-ol |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
|
C10 |
112-30-1 |
Decan-1-ol |
|
|
No systemic toxicity expected based on read across of a dermal study on Fatty Alcohol Blend of which decan-1-ol is a constituent, and on read-across from an oral study on hexan-1-ol. No adverse systemic effects were observed at the highest dose in either study. |
|
C11 |
112-42-5 |
Undecan-1-ol |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
2 |
C12 |
112-53-8 |
Dodecan-1-ol |
Rat 5wk |
Diet |
2000 mg/kg (Hansen,1992a) |
2 |
C13 |
112-70-9 |
1-Tridecan-1-ol (supporting) |
Rat 2 wk |
Gavage |
184 mg/kg (Rhodes, 1984) |
2 |
C14 |
112-72-1 |
Tetradecan-1-ol |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
2 |
C15 |
629-76-5 |
Pentadecan-1-ol |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
2 |
C16 |
36653-82-4 |
Hexadecan-1-ol |
Rat 4 wk
|
Diet
|
>1000 mg/kg (Henkel, 1985a)
|
2
|
C16 |
36653-82-4 |
Hexadecan-1-ol |
Dog 13 wk
|
Diet
|
>1054 mg/kg (Sc.Assoc, 1966b) |
2 |
C16 |
36653-82-4 |
Hexadecan-1-ol |
Rat 13 wk |
Diet
|
>4257 mg/kg |
2 |
C18 |
112-92-5 |
Octadecan-1-ol |
Rat 4 wk
Rat 5 wk |
Gavage
Diet |
>1000 mg/kg (Henkel, 1986a) 2000 mg/kg (Hansen, 1992b) |
1
2 |
C18 |
143-28-2 |
9-Octadecen-1-ol, (9Z)- |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
2 |
C20 |
629-96-9 |
Icosanan-1-ol |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
2 |
C22 |
661-19-8 |
Docosan-1-ol |
Rat 26 wk |
Gavage |
1000 mg/kg (Iglesias,2002a) |
1
|
C22 |
661-19-8 |
Docosan-1-ol |
Dog 26 wk |
Gavage |
2000 mg/kg (Iglesias,2002b) |
1 |
C24 |
506-51-4 |
Tetracosan-1-ol |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
|
C8 |
60435-70-3 |
2-methylheptan-1-ol |
|
|
|
|
C9 |
68515-81-1 |
Nonan-1-ol, branched and linear |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
|
C10 |
90342-32-8 |
Decan-1-ol, branched and linear |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
2 |
C11 |
128973-77-3 |
Undecan-1-ol, branched and linear
|
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
|
C13 |
90583-91-8 |
Tridecan-1-ol, branched and linear (supporting) |
|
|
Low systemic toxicity expected |
2 |
C15 |
90480-71-0
|
Pentadecan-1-ol, branched and linear |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
2 |
C7-9 |
|
Alcohols, C7-9 |
Rat 1-wk
Rat 1 wk |
Gavage
Gavage |
4175 mg/kg 128 mg/kg(Rhodes, 1984) |
2
2 |
C8-10 |
|
Fatty Alcohol Blend |
rat 90 day |
dermal |
1000 mg/kg bw/day (WIL Research, 1995) |
2 |
C9-11 |
|
Alcohols, C9-11 |
Rat 2 wk |
Gavage |
<4150 mg/kg(Brown, 1970) |
2 |
C9-11 |
|
Alcohols, C9-11- branched and linear |
Rat 9-day |
Inhalation |
<4150 mg/kg(Brown, 1970) |
2 |
C11 |
|
Reaction mass of 2-methyldecan-1-ol and 2-propyloctan-1-ol and 2-ethylnonan-1-ol and 2-butylheptan-1-ol |
|
|
No systemic toxicity expected based on data for category indicating no adverse systemic effects at highest dose tested. |
|
C12-13 |
75782-86-4 |
Alcohols, C12-13 |
Rat 4wk
|
Gavage
|
300 mg/kg; (Sasol, 1999 |
1 |
C12-13 |
740817-83-8 |
Alcohols, C12-13-branched and linear |
Rat 4wk (read-across)
|
Gavage
|
300 mg/kg; (Sasol, 1999 |
1 |
C12-15 |
90604-40-3 |
Alcohols, C12-15-branched and linear |
Rat 2 wk |
Gavage
|
209 mg/kg(Rhodes, 1984) |
2 |
C14-15 |
75782-87-5 |
Alcohols, C14-15 |
Rat 90 day |
Diet |
167 mg/kg; |
2 |
C14-15 |
|
Alcohols, C14-15-branched and linear |
Rat 90 day (read-across) |
Diet |
167 mg/kg; |
2 |
References:
Veenstra G, Webb C et al., (2009) Human health risk assessment of long chain alcohols. Ecotoxicology and environmental safety 71 1016-1030.
PFA (2016). C6-24 Alcohols Category Report: Human Health. Version number: 01. Peter Fisk Associates Ltd. February 2016.
Justification for classification or non-classification
Based on the available data, it is concluded that there is no basis for classification and labelling of octadecan-1-ol. This is supported by the additional repeat dose studies that have been conducted in octadecan-1-ol together with the absence of any treatment related effects in the various types of repeated dose studies that have been conducted within the category. Therefore no classification is proposed for octadecan-1-ol according to Regulation (EC) No 1272/2008.
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.