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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- Acute oral toxicity was determined according to the procedure suggested by Hagan, E.C. (1959).
Hagan, E.C. (1959). Acute toxicity; Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 17-25. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
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:
- rat
- Strain:
- Wistar
- Remarks:
- albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 188-238 g.
- Fasting period before study: overnight.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum 7 days.
ENVIRONMENTAL CONDITIONS: maintained under standard laboratory conditions.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Observations: animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours post-dosage. Observations were made daily thereafter to a total of 14 days.
- Necropsy of survivors: animals sacrificed at the end of the 14-day observation period were subjected to complete gross necropsy.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: No clinical signs were noted.
- Gross pathology:
- no gross changes observed
Any other information on results incl. tables
Observations and measurements of body weight of the tested animals during the observation period are presented in the table below.
Table
Dose (g/kg) |
Animal no and sex |
Body weight (g) |
Hours | Days | Body weight (g) |
|||||||||
1 | 3 | 6 | 24 | 2 | 3 | 4 | 5 | 6 | 7 | -14 | ||||
5 | 1 M | 210 | N | N | N | N | N | N | N | N | N | N | N | 318 |
2 M | 220 | N | NO CHANGE OBSERVED | 230 | ||||||||||
3 M | 208 | N | 292 | |||||||||||
4 M | 218 | N | 354 | |||||||||||
5 M | 214 | N | 308 | |||||||||||
6 F | 206 | N | 270 | |||||||||||
7 F | 218 | N | 282 | |||||||||||
8 F | 206 | N | 248 | |||||||||||
9 F | 204 | N | 252 | |||||||||||
10 F | 192 | N | 242 |
N=Normal
D=Depression
SD=Slight Depression
XD=Severe Depression
+ = Animal Death
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as toxic/harmful according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- LD50 > 5000 mg/kg b.w.
- Executive summary:
The acute oral toxicity of the test material was tested in a limit test according to according to the procedure suggested by Hagan, E.C. (1959). Five male and five female Wistar-derived albino rats were orally administered the substance, at 5000 mg/kg b.w. During the 14 -day observation period, mortality, body weight, signs of pharmacologic activity and drug toxicity were noted. All surviving animals were sacrificed and were subjected to complete gross necropsy.
No substance-related findings, gross pathological changes or mortality was observed during the study. The body weight for both males and females was increased after 14 days.
LD50 > 5000 mg/kg b.w.
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