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EC number: 904-790-6 | 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
- EC Number:
- 904-790-6
- Molecular formula:
- C28H48O; C29H50O; C29H48O
- IUPAC Name:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:JN
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain Mice, CBA/JN
Sex Females (nulliparous and non-pregnant)
Age 7 to 8 weeks old, 21 to 25 grams
Supplier Charles River Italia S.p.A., Calco (Lecco), Italy
Weight range at arrival 17 to 20 grams
Acclimatisation period At least 5 days
Animals per cage 5 during acclimatisation; 1/cage during the study
Housing Polysulfone solid bottomed cages measuring 35.5 × 23.5 × 19
cm with nesting material
Cage control Daily inspected and changed as necessary (at least
twice/week)
Water drinking water supplied to each cage via a water bottle
Water supply ad libitum
Diet 4 RF 21 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo
Milanese (MI) Italy)
Diet supply ad libitum throughout the study
Room lighting Artificial (fluorescent tubes), daily light/dark cycle of 12/12
hours
Air changes Approximately 15 to 20 air changes per hour
Temperature range 22 °C ± 2 °C
Relative humidity range 55 % ± 15 %
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- In the main assay, the test item was topically administered at concentrations of 10, 5 and
2.5 % (w/w), in propylene glycol.
Five concentrations [10 (maximum feasible concentration), 5, 2.5, 1 and 0.5 % w/w in
acetone:olive oil 4:1 (v/v)] were tested in the preliminary phase. - Details on study design:
- A solubility trial was performed in order to establish if acetone/olive oil 4:1 v/v could be used as vehicle.
At concentrations of 50, 25 and 10 % w/w in acetone/olive oil 4:1 v/v, no dosable prepara-
tions were obtained. Therefore, 3 further vehicles were tested: DMSO, PEG and propylene
glycol at the same concentrations. Results of this trial indicated propylene glycol as vehicle
with a maximum achievable concentration oh 10%. - Positive control substance(s):
- other:
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- high dose group 10% w/w
Any other information on results incl. tables
Neither mortality nor clinical signs were recorded in animals treated at all dose levels investigated [10, 5 and 2.5 % (w/w)].
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
A slight increase in cell proliferation of draining lymph nodes was observed in the high dose group [10 % (w/w)], with a Stimulation Index of 1.70. The other calculated indices (SI) were 1.42 and 1.20 respectively, at a low and medium dose group [2.5 % and 5 % (w/w)
respectively]. No correlation with the doses nor statistical significance was observed. The above results indicate that the test item may elicit a sensitisation response. However, due to the borderline positive response, the absence of a dose-response relationship and statistical
significance, the observed reaction is not sufficient to require classification.
In the group treated with the positive control item, a Stimulation Index of 3.28 was calculated.
As it was greater than 2, the study was regarded as valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A slight increase in cell proliferation of draining lymph nodes was observed in the high
dose group [10 % (w/w)], with a Stimulation Index of 1.70. The other calculated indices
(SI) were 1.42 and 1.20 respectively, at a low and medium dose group [2.5 % and 5 % (w/w)
respectively]. No correlation with the doses nor statistical significance was observed. The
above results indicate that the test item may elicit a sensitisation response. However, due to
the borderline positive response, the absence of a dose-response relationship and statistical
significance, the observed reaction is not sufficient to require classification.
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