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EC number: 232-430-1 | CAS number: 8027-33-6 A complex combination of organic alcohols obtained by the hydrolysis of lanolin.
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Dose volume of 20 ml/kg bw used to administer dosage of 2000 mg/kg bw. Dose volume should not normally exceed 10 ml/kg for aqueous vehicles. Does not affect relevance of results produced.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- Dose volume of 20 ml/kg bw used to administer dosage of 2000 mg/kg bw. Dose volume should not normally exceed 10 ml/kg for aqueous vehicles. Does not affect relevance of results produced.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: May and June 2000. Date of signature: 2nd August 2000
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Lanolin alcohols
- IUPAC Name:
- Lanolin alcohols
- Details on test material:
- Designation: Wollwachsalkohl / Lanolinalkohol
Batch no.: 6480
Receipt no.: 22921
Date of receipt: 07/05/2001
Characteristics: Yellow, solid
Storage conditions: at 7°C (+/- 2°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633, Sulzfeld
- Age at study initiation: Males - 36 days, Females - 45 days
- Weight at study initiation: 164 to 210 g
- Fasting period before study: 16 hours
- Housing: Granulated textured wood was used as bedding material for the cages. During the 14-day observation period animals were kept in groups of 2 or 3 animals in MARKOLON cages (type III).
- Diet: ad libitum access
- Water: as libitum access to tap water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 3°C)
- Humidity (%): 50% (+/- 15%)
- Air changes (per hr): Not stated in report
- Photoperiod (hrs dark / hrs light): The rooms were lit (150 lux at approximately 1.5 m room height) and darkened for periods of 12 hours each.
IN-LIFE DATES: From: Day 0 To: Day 14 (Day of sacrifice)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/ 20 ml/kg bw
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: not stated in report
- Lot/batch no. (if required): not stated in report
- Purity: not stated in report
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- not applicable - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration. All surviving animals were observed daily for a period of 14 days.
- Necropsy of survivors performed: yes. Gross pathological changes were recorded.
- Other examinations performed: during the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and smotomotor activity, behavious pattern. Attention paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. bodyweight. - Statistics:
- Standard deviation
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed.
- Clinical signs:
- other: No substance-related findings.
- Gross pathology:
- No substance-related findings
- Other findings:
- - Not detailed in report
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The substance is not classified as toxic or harmful by the oral route of exposure.
- Executive summary:
A study to determine the oral toxicity of the test substance was conducted following the OECD Guidelne 401 and EC guideline B1.
Under the test conditions (a single oral dose of the test material at 2000 mg/kg bw) to rats revealed no toxic symptoms.
The substance is not classified as toxic or harmful by the oral route of exposure.
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