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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-685-3 | CAS number: 1344-01-0
- 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: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 429.
- 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)
- Species:
- mouse
- Strain:
- other: CBA/CaCrl
- Sex:
- female
- Details on test animals and environmental conditions:
- The test was carried out on Nulliparous, non-pregnant female CBA/CaCrl strain mice. The sex and strain of mouse has been selected for this study in conformance with the design of the validated test method (OECD Guidelines for Testing of Chemicals Method 429, adopted 24 April 2002). Animals in the main study were in a body weight range of 16.9 to 20.5 g on the day before dosing commenced. Individual body weights were within ± 20% of the mean body weight for mice on the study. Based on information from the supplier the mice were approximately 8 to 10 weeks old on Day 1.
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 10, 25 and 50 % w/v
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- mercaptobenzothiazole (CAS No 149-30-4)
- Parameter:
- SI
- Remarks on result:
- other: 10% w/v: 0.8 25% w/v: 1.2 50% w/v: 1.3
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle Control: 1794 DPM 10% w/v: 1448 DPM 25% w/v: 2141 DPM 50% w/v: 2324 DPM
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Stimulation Index (SI) recorded for the test sample was 0.8 (10% w/v test sample), 1.2 (25% w/v test sample) and 1.3 (50% w/v) test sample. These values do not meet the criteria for classifying the substance as a skin sensitiser according to EU CLP criteria.
- Executive summary:
The skin sensitisation potential of the substance was tested in accordance with the OECD Guideline for Testing of Chemicals 429. Groups of four female CBA/CaCrl mice were subjected to topical applications of vehicle or of one of the test formulations (at concentrations of 10, 25 or 50% w/v) to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. The Stimulation Index (SI) recorded for the test sample was 0.8 (10% w/v test sample), 1.2 (25% w/v test sample) and 1.3 (50% w/v) test sample. These values do not meet the criteria for classifying the substance as a skin sensitiser according to EU CLP criteria.
Reference
Sample Identity |
Number of sites yielding lymph nodes |
Disintegrations per minute* (DPM) |
Disintegrations per minute per node (DLM) |
Stimulation Index (SI) |
Scintillation fluid with 5% w/v trichloroacetic acid |
- |
48 |
- |
- |
Vehicle control |
8 |
1794 |
224 |
- |
Test article, 10% w/w |
8 |
1448 |
181 |
0.8 |
Test article, 25% |
8 |
2141 |
268 |
1.2 |
Test article, 50% |
8 |
2324 |
291 |
1.3 |
* All scintillation counts corrected for the blank
SI = Test group DLM value / Control group DLM value
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted on the registered substance to determine the skin sensitisation potential of the substance. The skin sensitisation potential of the substance was tested in accordance with the OECD Guideline for Testing of Chemicals 429. Groups of four female CBA/CaCrl mice were subjected to topical applications of vehicle or of one of the test formulations (at concentrations of 10, 25 or 50% w/v) to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. The Stimulation Index (SI) recorded for the test sample was 0.8 (10% w/v test sample), 1.2 (25% w/v test sample) and 1.3 (50% w/v) test sample. These values do not meet the criteria for classifying the substance as a skin sensitiser according to EU CLP criteria.
Migrated from Short description of key information:
The registered substance is not sensitising to skin.
Justification for selection of skin sensitisation endpoint:
Study was conducted on the registered substance according to GLP standards and using OECD Testing Guideline 429.
Justification for classification or non-classification
The registered substance did not show skin sensitisation potential.
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.