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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-970-5 | CAS number: 112-42-5
- 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
The acute oral toxicity key study reports an LD50 value of >15800 mg/kg in rat in a reliability 2 study (Younger Labs 1972). The inhalation key study reports and LC50 value of 700 mg/m³ air in response to a 6 hour exposure (Younger Labs 1972), which is the only available information for the inhalation endpoint. The rabbit acute dermal LD50 value was reported to be >5010 mg/kg (Younger Labs 1972).
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Screening test with basic information and result reporting. Appears valid.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The observation period was 7 days, and animals per dose was not according to guideline.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 215-260g
- Route of administration:
- oral: gavage
- Vehicle:
- other: undiluted
- Details on oral exposure:
- No detail available.
- Doses:
- 5010 mg/kg, 7940 mg/kg, 12600 mg/kg, 15800mg/kg
- No. of animals per sex per dose:
- 5010mg/kg; 1F, 7940mg/kg; 1F, 12600mg/kg; 1F, 15800mg/kg; 3M, 2F.
- Control animals:
- not specified
- Details on study design:
- Observations were made for toxic signs and the viscera of the test animals were examined macroscopically. Observation period 7 days.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 800 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: Toxic signs included reduced appetite and activity and lethargy lasting two to three days.
- Gross pathology:
- Surviving animals were sacrificed seven days after dosing. The viscera appeared normal by macroscopic examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The rat oral LD50 for undecyl alcohol was >15800 mg/kg. The study was not conducted according to GLP and the observation period was 7 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 800 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Observation period was 10 days.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Average temperature inside chamber: 78F
Average relative humidity inside chamber: 80% - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- The rats were placed in a stainless steel chamber of 35 litres capacity and exposed to a concentrated atmosphere of vapours produced by passing a stream of air through 130.5 grams of the compound contained in a 300 milliliter flask. The sample was maintained at a temperature of 100C by immersing flask in heated sand bath. Vapours from the flask passed into one litre bottle to remove droplets and then into the chamber. Air flow through tthe sample was 4.0 litres per minute as measured by a calibrated rotameter. This was sufficient to violently agitate the liquid. No supplementary air was introduced inasmuch as the above supply was ample for the animals oxygen requirements.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 6 h
- Concentrations:
- 0.4 mg/l
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- The animals were observed for behaviour during exposure and for ten days following exposure. The viscera of the animals were examined macroscopically.
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 700 mg/m³ air
- Exp. duration:
- 6 h
- Mortality:
- There were no deaths during the exposure or the 10 days observation period.
- Clinical signs:
- other: Upon removal from the chambre the fur was roughened; respiration was normal and no other signs of toxic distress were noted.The ten day observation period was uneventful.
- Body weight:
- The weight gain was normal.
- Gross pathology:
- The viscera appeared normal by macroscopic examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Rat 6 hour LC50 was reported to be >700mg/m3 air. The study was equivalent to guideline. The result was read across from undecan-1-ol (CAS 112-42-5).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 700 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The undiluted compound was applied in increasing doses at increments of 0.2 fractional log intervals to the closely clipped, in tact skin of male/female rabbits.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 1.8-2.5kg
- Housing: individual cages - Type of coverage:
- occlusive
- Vehicle:
- other: undiluted
- Details on dermal exposure:
- Test material was applied to intact skin.
- Duration of exposure:
- 24 hours
- Doses:
- 3160, 5010 and 7940 mg/kg
- No. of animals per sex per dose:
- 3160 mg/kg; 1F, 5010mg/kg; 1M, 7940 mg/kg;1M, 1F.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 010 - < 7 940 mg/kg bw
- Based on:
- test mat.
- Mortality:
- A female rabbit died at 7940mg/kg dose level on day 4.
- Clinical signs:
- other: Reduced appetite and activity and lethargy (three to five days in survivors), increasing weakness, collapse and death.
- Gross pathology:
- At necropsy there was slight lung congestion, liver discolouration, enlarged gall bladder and slight gastrointestinal inflammation. Surviving animals were sacrificed 14 days after dosing. The viscera appeared normal by macroscopic examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The rabbit acute dermal LD50 was reported to be > 5010 mg/kg (but <7940 mg/kg). The study was not compliant with GLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 010 mg/kg bw
Additional information
The key inhalation data from Younger Labs (1972) was the best data available for this endpoint.
The highest average concentration in the test chambre is reported to be 700 mg/m3. The saturated vapour concentration calculated using the ideal gas equation on the basis of the physiocemical properties of undecan-1 -ol implies that the highest theoretically achievable vapour concentration for undecanol is less then the reported value of 700mg/m3. Therefore the recorded concentration in the key study represents the highest possible exposure concentration and can be considered for classification purposes. In order to support the key result, a read across is included from the structurally analogous substance 1 -decanol which reports an acute inhalation LC50 value of >71 mg/l (mist) (Scientific Associates, 1977).
All the reliability 3 and 4 supporting studies support the findings of the key studies by the Younger Labs, although the available information in the supporting studies was not sufficient for determining classification.The key study report by the Younger Laboratories (1972) was the most recent and high reliability source available, which was premise for its allocation as the key study.
Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:
Acute toxicity tests of the linear and essentially linear alcohols do not indicate any potential hazard for acute, dermal or inhalation toxicity. The available data for the Category have been reviewed with the conclusion that the long chain alcohols are of a low order of acute oral and dermal toxicity, and the inhalation LC50 is expected to be greater than the substantially saturated vapour concentration (Veenstra G, Webb C et al., 2009). Tests on various substances included in this category are all supportive of these results and do not warrant classification for most of the acute toxicity endpoints under GHS criteria. The majority of the substances are therefore not classified for acute toxicity in accordance with Regulation (EC) No 1272/2008. The only exception to this is hexan-1-ol, which finds that the acute dermal data for the test substance are consistent with Acute dermal tox category 4 and Acute oral tox 4 H302/R22, in line with the Annex VI entry. A full discussion of the Category can be found in the Human Health Alcohols C6-24 Category report (PFA, 2016).
Justification for classification or non-classification
Based on the available information, undecan-1 -ol is concluded not to need classification or labelling for the acute toxicity endpoints, in accordance with CLP (EC regulation 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.