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EC number: 205-583-7 | CAS number: 143-08-8
- 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
All the acute toxicity key studies are read across from decanol (112-30-1). The acute oral key study in rat reports an LD50 value of >5000 mg/kg (Eurofins 2009; rel 1). The acute inhalation key study in rat exposed the animals to atmosphere generated as mist for 1 hour, with a result of LC50 >71mg/L (Scientific Associates 1977; rel 2). The acute dermal key study in rat reports an LD50 value of >5000 mg/kg (Eurofins 2009; rel 1).
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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals Inc., Boyertown, PA
- Age at study initiation: Young adult (10-12 weeks)
- Weight at study initiation: 183-210 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-21C
- Humidity (%): 63-87 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 175mg/kg, 550 mg/kg, 1750mg/kg, 5000mg/kg
- No. of animals per sex per dose:
- 175mg/kg (1 animal), 550 mg/kg (1 animal), 1750mg/kg (1 animal), 5000mg/kg (3 animals)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for mortality, signs of gross toxicity and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. OBservations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- The acute oral toxicity (Guideline 425) Statistical Program (Westat, version 1.0 May 2001) was used for all data analyses including dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: All animals appeared active and healthy during the study. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour at the lower doses, however at the 5000mg/kg following administration all females exhibited ano-genital st
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14 day observation period.
- Other findings:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of >5000mg/kg is reported in a reliable study conducted according to an appropriate guideline. The study was also compliant with GLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: contract laboratory protocol
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: COX-CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 216 to 253 grams
- Housing: Glass chamber for the duration of exposure to the test substance which after the animals were placed in individual wire-bottomed cages elevated above droppings.
- Diet: Purina laboratory Chow, pelletized (ad libitum)
- Water: ad libitum
IN-LIFE DATES: Not stated. - Route of administration:
- other: mist
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: atmosphere generated as a mist
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: DeVilbiss Nebulizer
- Exposure chamber volume: 57 litres
- Method of holding animals in test chamber: shared glass chamber
- Source and rate of air: six litres per minute
TEST ATMOSPHERE
- Brief description of analytical method used: non specified
- Samples taken from breathing zone: not specified
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 1 h
- Concentrations:
- 71 mg/l
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed for gross effects at regular intervals on the day of exposure and daily thereafter for fourteen days. All animals were weighed at the beginning and end of the test period. - Statistics:
- No statistical analysis performed.
- Preliminary study:
- No preliminary study.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 71 mg/L air
- Exp. duration:
- 1 h
- Mortality:
- All rats survived the 1 hour exposure and subsequent 14 day observation period.
- Clinical signs:
- other: During exposure, all animals displayed hypoactivity and/or ataxia, salivation and gasping. Generalised weakness was also evident when the animals were removed from the chamber at the end of the exposure. At the 24 hour observation period, all animals show
- Body weight:
- Final bodyweight records of the animals at termination (14 days) showed gains within expected limits, in all animals.
- Gross pathology:
- Gross necropsy of the animals at fourteen days showed slight to moderate pulmonary (all animals) and adrenal (two animals) congestion; otherwise findings were unremarkable.
- Other findings:
- The lungs were affected in all rats.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result was read across from 1-decanol. The rat 1 hour LC50 for Alfol 10 (mist) was >71 mg/l. Signs of intoxication during exposure included lethargy,and/or ataxia, salivation and gasping. Gross necropsy revealed congestion of the lungs in all animals.
Reference
Table 1: Concentrations, exposure conditions and number of evident toxicity per animals treated.
Nominal Conc. (mg/L) |
Number with evident toxicity (#/total) |
||
Males |
Females |
Combined |
|
71 |
0/5 |
0/5 |
0/10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 71 000 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
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The humidity was below the targeted lower limit of 30% during the study. A portable humidifier was used to increase the humidity levels during this time.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace animals Inc., Boyertown, PA
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 221-236g males, 182-200g females
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet: Purina rodent chow, ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 19-52
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: trunk
- % coverage: 10
- Type of wrap if used: the gauze pad under which the test material resided was wrapped with tape to avoid dislocation of the pad and to minimize loss of the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently cleansed with a 3% soap solution followed by ethanol then tap water using a clean paper towel to remove any residual test substance
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): individual doses were calculated based on the initial body weights, taking into account the specific gravity of the test substance. - Duration of exposure:
- 24 hours
- Doses:
- 5000mg/kg
- No. of animals per sex per dose:
- 5M, 5F
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded prior to test substance application (initial) and again on days 7 and 14. The animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Tissues and organs of the thoracic and abdominal cavities were examined. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: Other than the dermal irritation noted at all dose sites between days 1 and 12, there were no other clinical findings recorded for any animal over the course of the study.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14 day observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of >5000 mg/kg is reported in a reliable study conducted according to an appropriate guideline. The study was compliant with GLP.
Reference
Erythema, desquamation and hyperkeratosis were present at the dose site.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
The acute toxicity key results are read across from decanol (CAS 112 -30 -1) based on the notion that the available acute toxicity across category is found to be low. The available reliability 4 supporting studies for nonan-1-ol for each of these endpoints further support the read across results.
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 it is proposed that nonan-1-ol will not be classified for acute oral, inhalation or dermal toxicity in accordance with CLP (EC regulation 1272/2008).
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