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Diss Factsheets
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EC number: 204-667-0 | CAS number: 123-96-6
- 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
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Endpoint summary
Administrative data
Description of key information
One acute study by oral route is available for octan-2-ol with an LD50 > 2000 mg/kg. No mortality was observed indicating that acute toxicity is of low concern. No acute studies are available by dermal route or inhalation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 October 2009 to 10 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar strain rats were supplied by Harlan Laboratories UK Limited, Bicester, Oxon, UK. On receipt the animals were randomly allocated to
cages. The females were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random
and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the
animals were eight to twelve weeks of age. The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of
an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food
(2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study. The diet, drinking
water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the
purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these
targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour
and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have
affected the purpose or integrity of the study. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was
calculated according to its fasted bodyweight at the time of dosing. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 (females only)
- Control animals:
- no
- Details on study design:
- Clinical observations were made ½, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks
were made twice daily.
Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of
an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No
tissues were retained. - Statistics:
- Not applicable
- Preliminary study:
- A single animal was tested at a dose level of 2000 mg/kg. No mortality was observed.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the course of the study.
- Clinical signs:
- other: Signs of systemic toxicity noted in all animals up to six days after dosing were hunched posture, lethargy, ataxia, pilo erection, prostration, splayed gait, increased respiratory rate and noisy respiration. Red/brown staining around the snout was also
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The acute oral toxicity of octan-2-ol was evaluated in rats in a Fixed Dose Procedure study specified in EU Method B1 bis. Octan-2-ol was administered without vehicle. All animals (female Wistar strain rat) were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. Clinical observations were made ½, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose on one female. In the absence of mortality, an additional group of three animals was treated at a dose level of 2000 mg/kg.
There were no deaths during the course of the study. Signs of systemic toxicity noted in all animals up to six days after dosing were hunched posture, lethargy, ataxia, piloerection, prostration, splayed gait, increased respiratory rate and noisy respiration. Red/brown staining around the snout was also noted in one animal one day after dosing. Noisy respiration persisted in one animal throughout the observation period.
Animals appeared normal 3, 6 or 7 days after dosing, except for one animal which showed signs of systemic toxicity at all observations.
Four animals showed bodyweight loss during the first week with expected gain in bodyweight during the second week. The remaining animal showed expected gains in bodyweight during the study. No abnormalities were noted at necropsy.
Thus, the acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the available data and CLP criteria, no classification is warranted for the acute toxicity. In addition, no classification for Specific Target Organ Toxicity-Repeated Exposure is warranted according to CLP criteria.
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