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EC number: 290-844-8 | CAS number: 90268-43-2
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- From May 15th to June 25th, 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Data have been obtained from a study on a substance with structural similarity. Good laboratory practice regulation GLP; United States Food and Drug Administration Good Laboratory Practice Regulation. Existing OECD TG 401 (EU B.1) data would normally be acceptable but testing using this deleted method must no longer be performed.
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)
- Version / remarks:
- The OECD 401 has been deleted in 2002. Now alternative is OECD Test Guidelines 423. Existing OECD TG 401 (EU B.1) data would normally be acceptable but testing using this deleted method must no longer be performed.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines for Non-Clinical Studies of Drug Manual
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Lanoline Alcohol
- IUPAC Name:
- Lanoline Alcohol
- Test material form:
- other: solid
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
- Selection: according to EC and OECD guidelines;
- Numbers of animal: 1O (5 male, 5 female)
- Age at study initiation: male 36 days; female 45 days
- Weight at study initiation: 164 - 210 g
- Fasting period before study: discontinued approx. 16 hours before administration
- Housing: groups of 2 or 3 animals in Makrolon cages (type III), with bedding material in granulated texture wood; The cages where changed and cleaned twice a week. Periodic analysis of the bedding material for contaminants based on EPA/USA is conducted at least once a year by LUFA-ITL3.
- Diet : standard diet Altromin 1324. Periodic analysis of the food for contaminants based on EPA/USA is conducted at least twice a year by AUA2 (limitation for contaminants in the diet), with certificates of analysis.
- Water: tap water ad libitum. Drinking water is examined according to the 'Deutsche Trinkwasserverordnung, Bun- desgesetzblatt, Jahrgang 1990' by the Hamburger Wasserwerke, D-205 39 Hamburg, at least four times a year. In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a
year for means of bacteriological investigations according to the German 'Deutsche Trinkwasserverordnung, Bundesgesetzblatt, Jahrgang 1990, Anlage 4.
- Acclimation period: at least 5 adaptation days;
- Identification: by coloured marks and cage label.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50% ± 15%
- Photoperiod (hrs dark / hrs light): 150 lux at approx 1.5 room height. Darkened for periods of 12 hours each.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Selection of route of administration: according to OECD guidelines and most likely route of exposure.
- Administration volume: 20 ml/kg b.w - Doses:
- 2.000 mg/kg b.w
- No. of animals per sex per dose:
- 5 males
5 females - Details on study design:
- - Duration of the experiment: 1 test day, 2 recovery weeks.
- Duration of observation period following administration: 14 days
Observation at A 5, 15, 30, 60 minutes; 3, 6, 24 hours
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Observations on mortality at least once daily.
No compound-related mortality. LD50 could not be calculated because no lethality occurred in the limit test. - Clinical signs:
- other: No toxic symptoms
- Gross pathology:
- At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically.
All gross pathological changes were recorded. From animals which survive 24 hours or longer a microscopic examination of all organs which showed evident lesions was performed, if necessary.
Autopsy and macroscopic inspection of animals which died prematurely were carried out as soon as possible after exitus. - Other findings:
- Observation at least once a day until each working day during the follow-up period: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity, possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Any other information on results incl. tables
Summarized results are indicated in Table 1.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Under the present test conditions a single oral administration 2000 mg (limit test) lanoline alcohol to rats revealed no toxic symptoms.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments lanoline alcohol can be classified as relatively non-toxic. - Executive summary:
OECD Guideline 401 (Acute Oral Toxicity) has been performed in 2001.
The OECD 401 has been deleted in 2002. Now alternative is OECD Test Guidelines 423.
Five rats per sex were observed for 14 days following a single dose of 2000 mg/kg b.w (limit test).
Observations on mortality was done at least once daily, the LD50 could not be calculated due to no compound-related mortality observed.
Individual body weights were recorded before administration of the substance and at death changes in weight were calculated and recorded (table 1). Lanoline alcohol to rats revealed no toxic symptoms.
All gross pathological changes were recorded after autopsy and macroscopic inspection of animals.
Observations as changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity, possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma were observed.
No other findings were registered.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments lanoline alcohol can be classified as relatively non-toxic.
Further testing may not be considered necessary.
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