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EC number: 232-452-1 | CAS number: 8031-44-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- The primary dermal irritation of the substance in rabbits was evaluated by the test method described in Draize et al.1944
Draize, J.H., Woodard, G. and Calvery, H.O. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J.Pharm. & Ex. Ther. 82, 377. - GLP compliance:
- no
- Remarks:
- study was performed before GLP
Test material
- Reference substance name:
- Lanolin, hydrogenated
- EC Number:
- 232-452-1
- EC Name:
- Lanolin, hydrogenated
- Cas Number:
- 8031-44-5
- Molecular formula:
- UVCB: not available
- IUPAC Name:
- Lanolin, wool wax, hydrogenated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml (0.5 g). - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- six
- Details on study design:
- TEST SITE
- Area of exposure: the trunk of animal. The test material was applied to clipped areas of intact and abraded skin.
- Type of wrap if used: applications were made under occlusive patches (1'' x 1'' gauze, covered by adhesive tape). An impermeable occlusive wrapping was used.
Other: the abrasions were longitudinal epidermal incisions sufficiently depp to generate the stratum corneum but not so deep as to destroy the integrity of the derma.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hrs folowing application.
OBSERVATION TIME POINTS: at 24 and 72 hours the test sites were observed for erythema and edema.
SCORING SYSTEM:
- Method of calculation: the sites were individually examined and scored separately for edema and erythema at 24 and 72 hours.
Erythema and Edema formation
very slight erythema (barely perceptible) 1
well defined erythema 2
moderate to severe erythema 3
severe erythema (beet redness) to slight eschar formation
(injuries in depth) 4
total possible erythema score = 4
Edema formation
very slight edema (barely perceptible) 1
slight edema (edges of area well defined by definite raising) 2
moderate edema (area raised appr. 1 mm) 3
severe edema (raised more than 1 mm and extending beyond
area of exposure) 4
total possible edema score = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: clipped and abraded
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hrs
- Remarks on result:
- other: clipped and abraded
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: clipped and abraded
Any other information on results incl. tables
The summary of scores for skin irritation is presented in the table below.
Table
Rabbit no | Skin | 24 hours | 72 hours | ||
Erythema | Edema | Erythema | Edema | ||
1 | NA | 1 | 0 | 0 | 0 |
A | 1 | 0 | 0 | 0 | |
2 | NA | 1 | 0 | 0 | 0 |
A | 1 | 0 | 0 | 0 | |
3 | NA | 1 | 0 | 0 | 0 |
A | 1 | 0 | 0 | 0 | |
4 | NA | 1 | 0 | 0 | 0 |
A | 1 | 0 | 0 | 0 | |
5 | NA | 1 | 0 | 0 | 0 |
A | 1 | 0 | 0 | 0 | |
6 | NA | 1 | 0 | 1 | 0 |
A | 1 | 0 | 1 | 0 |
NA = Non-abraded skin
A = Abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as skin irritant according to CLP Regulation (EC) No.1272/2008
- Conclusions:
- Non-skin irritant
- Executive summary:
The substance was evaluated for its skin irritation potential according to a test method described by Draize et al. (1944). The substance was applied in the trunk of 6 New Zealand albino rabbits, to clipped areas of intact and abraded skin. Following application the trunk of each animal was covered with an impermeable occlusive wrapping. 24 hours following application the wrapping and test substance were removed and the test sited were individually examined and scored for erythema and edema at 24 and 72 hours.
The mean score for erythema (24 /72 hours) was 0.66 for 5 rabbits (reversible within 48 hrs) and 1 for all rabbits whereas edema was 0 for all animals.
Taking in consideration the erythema and edema score, it can be considered that the substance is not a skin irritant to rabbits.
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