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Diss Factsheets
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EC number: 252-091-3 | CAS number: 34562-31-7
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 Nov 2017-April 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- liquid
- Details on test material:
- Purity > 84%, yellow to amber liquid. Lot # 0000152614. Expiry date 06 March 2018.
Constituent 1
- Specific details on test material used for the study:
- The substance was stored at room temperature. Composition of test substance was reported to be [composition]. The test substance appeared as [description of substance] with [odour of substance]. The substance was expected to be stable for the duration of testing. The expiration date of the test substance was [expiration date].
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant:
- Microbiological status of animals, when known:
- Age at study initiation: 11-12 weeks
- Weight at study initiation:
- Housing: The animals were individually housed in plastic solid bottom cages during the dosing and resting phase of the study. After final weighing until sacrifice, animals were housed in their respective dose groups in plastic cages with bedding. Bedding in the plastic, solid bottom cages was changed at least once per week. Enrichment (e.g., nesting material) was placed in each cage. All caging conformed to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011).
- Diet (e.g. ad libitum): [Food source], ad libitum
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: 21 days
- Indication of any skin lesions: None
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 ˚C
- Humidity (%): 41-56%
- Air changes (per hr): 13. Airflow measurements were evaluated regularly and records are kept on file at testing facility.
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
- IN-LIFE DATES: Not reported
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Dose range finder: 100%, 50%, 25%, and 10%
- No. of animals per dose:
- Preliminary Irritation (4 groups): 2 per group
Test (3 groups): 5 per group
Vehicle (Negative) Control: 5
Positive Control: 5 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The treated groups and negative vehicle control group were compared using a One-Way Analysis of Variance (ANOVA), followed by comparison of the treated groups to control by Dunnett’s t-test for multiple comparisons (INSTAT Biostatistics, Graph Pad Software, San Diego, CA). Outlier analysis was conducted using Grubbs (1969).
Results and discussion
- Positive control results:
- Valid
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- All animals died
Any other information on results incl. tables
Test was not continued due to the lethality of the substance to mice. In dose-range finding studies in CD1 mice (one per dose), the substance was applied to the dorsal aspect of the ears at concentrations of 100% in AOO, 50%, and 10%. Animals either died or were killed in extremis within 24 h. The test was discontinued as it was felt that this extreme and perhaps idiosyncratic response prevented the test system from accurately predicting the sensitisation potential for humans.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was attempted to be tested for dermal sensitisation in OECD Guideline 429 (murine LLNA). In dose-range finding studies in CD1 mice (one per dose), the substance was applied to the dorsal aspect of the ears at concentrations of 100% in AOO, 50%, and 10%. Animals either died or were killed in extremis within 24 h. The test was discontinued.
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.
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