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Diss Factsheets
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EC number: 226-242-9 | CAS number: 5333-42-6
- 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
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:
- October until November 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: - missing test substance characterisation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- A goal of the investigation is it to win knowledge on the sign of poisoning, the lowest toxic and the deadly dose (LD50) of 2-Octyl-Dodecanol by oral administration at rats.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S.IVANOVAS, Kießlegg, Germany
- Age at study initiation: male 38; female 42 days
- Weight at study initiation: 100-105 g
- Fasting period before study: 15-16 hours
- Housing: single in Macrolon cages (type II)
- Diet : ALTROMIN 1323 (ad libitum)
- Water: tap water (ad libitum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24° ± 0.5
- Humidity (%): 60 ± 3
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): not mentioned
IN-LIFE DATES: From: October 1974 To: November 1974 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 50.4 ml/kg bw
single application by gavage - Doses:
- 25.2, 31.8, 40.0 and 50.4 ml/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 4 weeks
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, bodyweight and fodder consumption were determined - Statistics:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50.4 mL/kg bw
- Mortality:
- No animals died.
- Clinical signs:
- other: None incompatibility reaction was observed. After 20 hours no toxic symptoms was observed.
- Gross pathology:
- Dissection of surviving animals at the end of the experiment showed no pathological findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-Octyldodecan-1-ol is practically nontoxic after oral administration of high doses to rats.
- Executive summary:
2-Octyldodecan-1-ol is practically nontoxic after oral administration of high doses to rats. No mortality occured after oral administration of up to 50.4 ml/kg bw.
Reference
Table 1: Mortality and number of animals with evident toxicity
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity (#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
25.2 |
0/10 |
0/10 |
0/20 |
- |
0/10 |
0/10 |
0/20 |
31.8 |
0/10 |
0/10 |
0/20 |
- |
0/10 |
0/10 |
0/20 |
40.0 |
0/10 |
0/10 |
0/20 |
- |
0/10 |
0/10 |
0/20 |
50.4 |
0/10 |
0/10 |
0/20 |
- |
0/10 |
0/10 |
0/20 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 42 316 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Value:
- 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:
- October to November 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: missing test substance characterisation, reduced observation period of 7 days, no information on clinical observations and body weights
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: HAZARDOUS SUBSTANCES, Part 191, Section 11, FDA, Washington 1965
- GLP compliance:
- no
- Test type:
- other: Rabbits were exposed to test substance for 24 hours on intact and scarified skin. The treatment was followed by a 7-day observation period. Skin reactions, behaviour, general condition, food and water consumption and body weight gain were recorded.
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: laboratory breed
- Age at study initiation: not mentioned
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Altromin 2023, ad libitum, supplied by Altromin GmbH, Lage, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 60 ± 3
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 15 x 16 cm on the back of the animals, 3 animals per sex were treated on intact skin, 3 animals per sex were treated on abraded skin
- % coverage: 10
- Type of wrap if used: not wrapped
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30°C)
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.3-2.8 ml and 4.6-5.6 ml
- Constant volume or concentration used: no - Duration of exposure:
- 24 hours
- Doses:
- 1 and 2 mL/kg b.w.
- No. of animals per sex per dose:
- 3 with intact skin, 3 with scarified skin
- Control animals:
- other: control group (3 animals per sex with intact skin, 3 animals per sex with scarified skin) exposed with methylhydroxy ethyl Cellulose Gel 300 P, 1% in water
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: skin effects (erythema, edema) were recorded 5, 15, 30 min, 1, 2, 4, 24, 48, 72, 96, 120, 144 and 168 hours after removal of the test substance. General behaviour, food and water intake and body weight were recorded daily.
- Necropsy of survivors performed: no
- Other examinations performed: none - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 mL/kg bw
- Mortality:
- no mortality occured during the course of the study
- Clinical signs:
- other: only slight skin irritation noted
- Gross pathology:
- not performed
- Other findings:
- Necrosis and rhagades were not observed, growth of hair was not affected.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-Octyldodecan-1-ol is practically nontoxic after dermal administration to rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 1 679 mg/kg bw
Additional information
Experimental studies of 5 representatives of the category of Guerbet alcohols show a very low acute oral toxicity. Mortalities were only observed after application of the shortest chain Guerbet alcohol 2 -Butyl-octan-1-ol (C12) but only at doses of about 15,000 mg/kg bw and above. No clinical symptoms were observed for Alcohols C16 -20, branched and longer chain guerbet alcohols after application of very high doses. No pathological findings were observed at dissection of the animals.
Acute dermal toxicity studies of C16 and C20 Guerbet alcohol also show a low dermal toxicity at doses of up to 2 ml/kg. The test substances were applied on intact as well as on scarificed skin with a damaged skin barrier. No deaths occurred at any of the doses applied. In case of the experiment with scarificed skin it should be considered that doses systemically available were actually much higher.
Based on the available data it can be concluded that all Guerbet alcohols of the category are of very low acute oral and dermal toxicity.
Justification for classification or non-classification
Available data are conclusive but not sufficient for classification of 2 -octyldodecan-1-ol with regard to acute toxicity.
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.
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