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Diss Factsheets
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EC number: 921-548-5 | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This test was already available (it was performed for cosmetic regulation compliance), before REACH regulation requirements.
Test material
- Reference substance name:
- Hydrogenated Stearyl Olive Oil Esters
- Molecular formula:
- not available
- IUPAC Name:
- Hydrogenated Stearyl Olive Oil Esters
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Young adult female guinea pigs of the Dunkin-Hartley strain were obtained from Charles River. Animais were ordered nulliparous and non-pregnant, whithin the weight range of 300 to 350 grams and 4 to 5 weeks of age.
After arrivai, animais were identified by temporary markings. An acclimatisation period of at least 5 days allowed the assessment of the health status of the animals.
Animais were housed in groups of 5, in stainless steel cages. Controls for the animal room were set to maintain temperature within the range of 20-24°C and relative humidity within the range of 45-65%.
Both diet and water were allocated ad libitum. The food was an antibiotic-free pelleted diet, Altromin MSK, obtained from A. Rieper.
Food and water were checked on a regular basis to control the presence of contaminant substances.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 hours, repeated at weekly intervals (days 8 to 9, 15 to 16 of the study)
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 100%, 0.2ml
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 guinea pigs
- Details on study design:
- Animals were allocated to treatment to give a test group of 20 animals and a control group of 10 animals.
On the day of treatment (day 1), the hair was clipped from the left flank of each animal. Animals of the test group were treated with the undiluted test product. A gauze patch measuring 20 x 20 mm was covered with 0.4 ml of the test substance and placed onto the selected skin area. This was secured in position by encircling the trunk of animal with a length of adhesive strapping. The animals of the control group were similarly treated with the selected vehicle i.e. corn oil.
After a 6-hour exposure period, the dressings were removed and the treated areas were cleaned of remaining test substance or vehicle by washing with warm water.
After approximately 24 hours after removal, the treated sites were examined for signs of reaction to treatment. The signs were scored using the scale previously described (see paragraph 3.3.2).
These procedures were repeated at weekly intervals (days 8 to 9 and 15 to 16 of the study).
On day 29, the hair was removed with electric clippers from both the anterior and posterior regions of the right flank of all animals:
A 0.2 ml aliquot of the undiluted test substance was spread evenly over an absorbent patch measuring approximately 20 x 20 mm. This was placed onto the skin of the posterior region of the prepared site on the right flank. All animals of both the treated and the control groups were treated with both the test product and the vehicle. After a 6-hour exposure period, the dressings were removed and the treated areas were cleaned of remaining test substance or vehicle by washing with warm water.
After approximately 21 hours after removal of the patches, the treated sites were again clipped free of hair. Three hours later (i.e. 24 hours after removal of the patches), treated sites were examined for signs of reaction to treatment. The signs were scored using the scale previously described ( - Challenge controls:
- A 0.2 ml aliquot of the vehicle selected for the challenge i.e. acetone was spread evenly over an absorbent patch measuring approximately 20 x 20 mm and was placed onto the anterior region of the prepared site. All animals of both the treated and the control groups were treated with both the test product and the vehicle.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not tested
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- changes in body weight during the period of the study were generally similar in animals from both test and control groups.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- changes in body weight during the period of the study were generally similar in animals from both test and control groups.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% of vehicle selected for challenge i.e. acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- changes in body weight during the period of the study were generally similar in animals from both test and control groups.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% of vehicle selected for challenge i.e. acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- changes in body weight during the period of the study were generally similar in animals from both test and control groups.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% of vehicle selected for challenge i.e. acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- changes in body weight during the period of the study generally similar in animals from both test and control groups. One animal from the control group was found dead day7. Necropsy examination revealed no abnormalities.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% of vehicle selected for challenge i.e. acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- changes in body weight during the period of the study generally similar in animals from both test and control groups. One animal from the control group was found dead day7. Necropsy examination revealed no abnormalities.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The skin sensitization test was performed according to OECD 406 guideline. The data indicate that, in the guinea pig, the test product does not elicit a sensitisation response.
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