Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
Endpoint summary
Administrative data
Description of key information
Under test conditions, the substance was not a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Batch No.: OP.1501019
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- 8 (2 mice/group) female mice aged between 9 and 11 weeks were used for preliminary assay and 25 (5 mice/group) female mice between 9 and 11 weeks for main study. The animals were nulliparous and non-pregnant.
The rats were provided with feed (1334-P Maintenance Diet -Rat/mice) and water (UV sterilised water) ad libitum. Moreover, environmental conditions were strictly controlled: the temperature was between 19 to 23 °C with a relative humidity of 49-58% and a minimum 15 air changes/hour. - Vehicle:
- dimethyl sulphoxide
- Concentration:
- The test substance was tested at concentrations of 5% - 10% - 25% (w/w).
The preliminary assay was performed for the selection of the doses.During the preliminary assay no eryhtema was observed and an increase of less than 25% in ear thickness was observed at tested concentrations of 2.5% - 5% - 10% - 25%. - No. of animals per dose:
- 5 mice were used for group: G1, vehicle control; G2, 5% test substance; G3, 10% test substance; G4, 25% test substance; G5, positive control.
- Details on study design:
- PRELIMINARY STUDY:
four groups of mice comprising 2 females per group were treated with the test substance, applied at 2.5%, 5%, 10% and 25% (w/w) in Dimethylsulphoxide (DMSO) (25 µL/ear) for three consecutive days (days 0, 1 and 2). Clinical observations (including systemic clinical signs and scoring of irritation) were recorded daily during the experiment. Ear thickness was measured on days 0, 2 and 5. Body weight was recorded on days 0 and 5.
MAIN STUDY:
Three groups (G2 to G4) were treated topically for three consecutive days (days 0, 1 and 2) on the dorsal surface of both ears (25 L/ear) with the test substance at concentrations of 5%, 10% and 25% (w/w) the test substance in dimethylsulphoxide, respectively. Mice from vehicle control group (G1) and positive control group (G5) were handled in the same manner but received 25 L/ear of vehicle Dimethylsulphoxide (DMSO) and 25% a-Hexylcinnamaldehyde (v/v) in vehicle (Dimethylsulphoxide (DMSO)), respectively. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical analysis was carried out for the assessment of the dose response relationship and pair-wise comparison made between the treatment and the solvent/vehicle control group. All the parameters characterised by continuous data such as body weight was subjected to Bartlett’s test.
However, as the DPM was not homogenous it was directly subjected to Student’s t-test. To compare vehicle and positive control data, Student’s t-test was performed to calculate significance. - Positive control results:
- A positive response for HCA (a-hexylcinnamaldehyde) of SI=6.85 confirmed the reliability of the test procedure.
The test item is regarded as a skin sensitiser when the SI for a dose group is > 3 together with consideration of a dose-response relationship. - Key result
- Parameter:
- SI
- Value:
- ca. 2.16
- Test group / Remarks:
- G4: test substance concentration of 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.69
- Test group / Remarks:
- G3: test substance concentration of 10%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.18
- Test group / Remarks:
- G2: test substance concentration of 5%
- Cellular proliferation data / Observations:
- A statistically significant increase in DPM was observed at 25% (w/w) test substance in Dimethylsulphoxide (DMSO) and 25% (v/v) a-Hexylcinnamaldehyde in DMSO when compared to vehicle control group values (see Table below).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under test conditions, the test item was not a skin sensitiser.
Reference
Table 1
Group N° | Dose Concentration (%) | N° of Mice Used | Group Mean DPM | Stimulation Index (SI) |
G1 | Dimethylsulphoxide (DMSO) | 5 | 1030.60 ± 91.51 | 1 |
G2 | 5% Recovery titanium for ceramic frits (w/w) | 5 | 1220.60 ± 531.91 | 1.18 |
G3 | 10% Recovery titanium for ceramic frits (w/w) | 5 | 1738.00 ± 406.87 | 1.69 |
G4 | 25% Recovery titanium for ceramic frits (w/w) | 5 | 2225.20↑ ± 534.37 | 2.16 |
G5 | 25% HCA (v/v) | 5 | 7062.20 ↑↑ ± 2128.34 | 6.85 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available, the substance has not to be classified as skin sensitiser.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.