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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 680-341-5 | CAS number: 41438-38-4
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, according to guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- draft
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Methods for the determination of toxicity, Annex to Directive 96/54/EC (OJ n° L248 of 30.9.96), Part B, Method B.6. Skin sensitization
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Janvier, Le Genest-Saint-Isle, France- Age at study initiation: 9 weeks old- Weight at study initiation: mean±SD 19.8±1.4 g- Housing: individually in disposable crystal polystsrene cages (22cmx8.5cmx8cm)- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 days before the beginning of the studyENVIRONMENTAL CONDITIONS- Temperature (°C): 22±2- Humidity (%): 30 to 70- Air changes (per hr): 12 cycles of filtered, non-recycled air- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.5, 5 and 50% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:- Compound solubility: the test item was freely soluble in vehicle, acetone/olive oil (4/1, v/v)MAIN STUDYANIMAL ASSIGNMENT AND TREATMENT- Name of test method: LLNA- Criteria used to consider a positive response: stimulation index ≥3TREATMENT PREPARATION AND ADMINISTRATION: On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- no data
- Positive control results:
- In the positive control group given HCA at the concentration of 25 %, an increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI=11.32) were noted.
- Parameter:
- SI
- Remarks on result:
- other: 2 (0.5%): 1.37, 3 (5%): 1.08, 4 (50%): 1.99, 5 (control positive): 11.32
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 1 (control): 1226.59, 2 (0.5%): 1686.53, 3 (5%): 1328.39, 4 (50%): 2443.20, 5 (control positive): 13886.44
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Under experimental conditions, the test item Mexoryl SBU does not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
- Executive summary:
The aim of this study was to evaluate the potential of the test item Mexoryl SBU to induce delayed contact hypersensitivity using the murine LLNA. The study was conducted in compliance with the principes of GLP Regulations and according to OECD guidelines 406 and 429 (draft). Five groups of four animals received 0.5, 5 and 50 % of test item, vehicle (negative control group, receiving a mixture acetone/olive oil (4/1, v/v)) and reference item α-hexylcinnamaldehyde (HCA)at the concentration of 25 % (v/v) (positive control group).
No mortality and no clinical signs were observed. No cutaneous reactions and no increase in ear thickness were observed in the animals of the treated groups. No lymphoproliferation was noted at any tested concentration, while significant lymphoproliferation was observed with the reference item.
In conclusion, the test item did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The aim of this study was to evaluate the potential of the test item Mexoryl SBU to induce delayed contact hypersensitivity using the murine LLNA. The study was conducted in compliance with the principes of GLP Regulations and according to OECD guidelines 406 and 429 (draft). No mortality and no clinical signs were observed. No cutaneous reactions and no increase in ear thickness were observed in the animals of the treated groups. No lymphoproliferation was noted at any tested concentration, while significant lymphoproliferation was observed with the positive reference item.
In conclusion, the test item did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
Justification for selection of skin sensitisation endpoint:
key study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Justification for classification or non-classification
According to the Globally Harmonized System of Classification and Labelling of Chemicals and to CLP-Regulation (EC) No. 1272/2008,the test item should not be classified as skin sensitizer.
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.