Registration Dossier
Registration Dossier
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: 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- Between 23 March 2010 and 6 April 2010
- 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. GLP Compliance statement (OK GLP standards); GLP standards published as OECD (ENV/MC/CHEM(98)17); Requirements of Directives 2004/9/EC and 2004/10/EC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p 31: evaluation and skin reactions.
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- Lanoline Alcohols
- IUPAC Name:
- Lanoline Alcohols
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan laboratories UK Limited
- Females were nulliparous and non-pregnant.
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: at least 200 g. The variation did not exceed ± 20% of the mean weight for each sex.
- Acclimation period: at least five days
- Marking: number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
- Housing: On receipt the animals were randomly allocated to cages. Rats housed in suspended solid-floor polypropylene cages furnished with woodflakes. Animals were housed individually during the 24 hour exposure period and in group of five, by sex.
- Diet: ad libitum, Teklad Global Rodent diet supplied by Harlan Teklad, UK.
- Water: ad libitum
The diet, drinking water and bedding were routinely analysed and considered not to contain any contaminants.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): limits of 19 - 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes
- Photoperiod (hrs dark / hrs light): lighting controlled by a time switch, to have twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- pre-treatment: on day before treatment the back and lanks of each animal were clipped free of hair.
- Area of exposure: 10% of the total body surface area.
- Type of wrap if used: a piece of surgical gauze with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Wipping: after the contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test material.
- Time after start of exposure: animals were caged individually for the 24 hours exposure period.
Shortly after dosing the dressing were examined to ensure that they were securely in place.
TEST MATERIAL
- Amount applied: 2000 mg/kg with arachis oil BP. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males
5 females - Details on study design:
- - Duration of observation period following administration: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes, rats were killed by cervical dislocation. The gross necropsy consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: once daily for fourteen days the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J H (1977) "Dermal and Eye Toxicity tests" Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and
Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p 31: evaluation of skin reactions (table 1).
- Individual bodyweights were recorded prior to application of the test material on Day 0 and on Day 7 and 14.
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:
- No deaths
- Clinical signs:
- other: No signs of systemic toxicity No Individual dermal reactions for males No Individual dermal reactions for females No signs of dermal irritation
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987)
Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008.
A group of ten animals (Five males and five females) was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study, all animals were subjected to gross necropsy.
Mortality, no signs of systemic toxicity and no signs of dermal irritation were observed. No abnormalities were noted at necropsy.
Animals showed expected gains in bodyweight over the study period except for one female which showed no gain in bodyweight during the first week with expected gain in bodyweight during the second week.
It could be concluded that the acute dermal median lethal dose (LD5o) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
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.
