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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

Endpoint summary
Administrative data
Description of key information
skin irritation: not irritating
eye irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 18th 1980 to December the 12th 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: The procedure followed was a modification of that desribed by Draize
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: not stated
- Age at study initiation: about 3 months
- Weight at study initiation: 2 kg
- Housing: housed in galvanised or stainless steel cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Animals were acclimitised at least 3 days prior to test initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darkness
IN-LIFE DATES: From Day 0 To: End of study - Vehicle:
- not specified
- Controls:
- other: yes, the other eye was used for control purposes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): If any of the test article remained in the eye for 24 hours, the eye was washed out with lukewarm water after the 24 hour reading.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: not stated - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- for all animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 hour
- Irritant / corrosive response data:
- The test material showed no effects to either the cornea, iris or conjuctivae.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not an occular irritant to rabbits under the conditions of the test.
- Executive summary:
The test substance is not an occular irritant to rabbits under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a non-standard skin irritation study, six rabbits each received a single dermal application of 0.5 mL of the test substance (mixed as a 50% gravimetric mineral oil suspension) on two test sites, one abraded and one intact (Cade, 1980). The test substance was covered with a surgical gauze pad and the entire trunk of each animal was encased in an impermeable occlusive wrapping fixed in place with adhesive tape. The wrapping and the test substance were removed 24 h following application. Remaining test substance was gently wiped from the skin, and each test site was individually examined and scored at 24 and 72 h after application for erythema and edema using the Draize skin scoring scale. For all six animals, mean scores from the 24 and 72 h readings were 3 for erythema and 1.7 for edema on intact skin. The irritant effects were not reversible within 72 h. Under the conditions of the test, the test substance was irritating to the skin.
However, the skin irritation study was considered inappropriate and not suitable for classification as the exposure conditions presenting a worst case scenario compared to the current OECD test guideline 404. According to the current OECD 404, the patch with the test substance should be loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period, which is normally 4 hours. This is in contrast to the exposure conditions of the available in-vivo skin irritation study of Cade (1980): the exposure period lasted 24 h under occlusive conditions indicating worst case conditions.
Furthermore, the available dermal acute toxicity study in rats indicates no signs of skin irritation at a dermal dose level of 2000 mg/kg bw. In accordance with column 2, 8.1.1 of Annex VIII of the REACH regulation, an in-vivo skin irritation study does not need to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg bw). Based on the exposure conditions of the skin irritation study and the outcome of the acute dermal toxicity study (no signs of skin irritation), the in-vivo skin irritation study was disregarded and the result not used for classification. Based on the results of the acute dermal toxicity study, the test substance is not classified as a skin irritant.
Eye irritation was assessed and the test substance was found not to be an ocular irritant to rabbits under the conditions of the test.
Justification for classification or non-classification
The available data on skin and eye irritation/corrosion of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and according to Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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