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EC number: 607-233-2 | CAS number: 2343-89-7
- 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
Endpoint summary
Administrative data
Description of key information
In a recently conducted, reliable, guideline LLNA study, the substance gave a negative ie non sensitising result.
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:
- 21/5/15 to 25/6/15
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Horst, The Netherlands
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: Suspended solid floor polypropylene cage
- Diet (e.g. ad libitum): Free access to 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark, 12 hours light - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25, 50 and 100% v/v in vehicle
- No. of animals per dose:
- 4
- Key result
- Parameter:
- SI
- Value:
- 1.48
- Test group / Remarks:
- 25%
- Remarks on result:
- other: negative
- Key result
- Parameter:
- SI
- Value:
- 1.35
- Test group / Remarks:
- 50%
- Remarks on result:
- other: negative
- Key result
- Parameter:
- SI
- Value:
- 1.36
- Test group / Remarks:
- 100%
- Remarks on result:
- other: negative
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
Introduction
A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Methods
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.
Results
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (% v/v) in acetone:olive oil 4:1 Stimulation Index Result 25 1.48 Negative 50 1.35 Negative 100 1.36 Negative Conclusion
The test item was considered to be a non-sensitizer under the conditions of the test.
Reference
Individual Clinical Observations and Mortality Data
Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | |||||
Concentration (% v/v) in acetone/olive oil 4:1 | Animal Number | Pre-dose | Post-dose | Pre-dose | Post-dose | Pre-dose | Post-dose | |||
Vehicle | 1 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vehicle | 1 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vehicle | 1 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vehicle | 1 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | 2 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | 2 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | 2 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | 2 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 3 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 3 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 3 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 3 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
100 | 4 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
100 | 4 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
100 | 4 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
100 | 4 -4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Individual Body Weights and Body Weight Change
Body Weight (g) | ||||
Concentration (% v/v) in acetone/olive oil 4:1 | Animal Number | Day 1 | Day 6 | Body Weight Change (g) |
Vehicle | 1 -1 | 20.3 | 20.5 | 0.2 |
Vehicle | 1 -2 | 20.4 | 21.1 | 0.7 |
Vehicle | 1 -3 | 19.5 | 20.7 | 1.2 |
Vehicle | 1 -4 | 18.8 | 19.4 | 0.6 |
25 | 2 -1 | 20.7 | 20.8 | 0.2 |
25 | 2 -2 | 21.0 | 21.1 | 0.1 |
25 | 2 -3 | 18.4 | 18.7 | 0.3 |
25 | 2 -4 | 22.1 | 22.0 | -0.1 |
50 | 3 -1 | 17.7 | 19.8 | 2.1 |
50 | 3 -2 | 22.3 | 21.2 | -1.1 |
50 | 3 -3 | 19.1 | 19.9 | 0.8 |
50 | 3 -4 | 17.8 | 18.3 | 0.5 |
100 | 4 -1 | 19.1 | 19.6 | 0.5 |
100 | 4 -2 | 19.4 | 20.2 | 0.8 |
100 | 4 -3 | 22.4 | 21.4 | -1.0 |
100 | 4 -4 | 21.0 | 20.7 | -0.3 |
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
The substance gave a negative ie non sensitising result in a reliable LLNA and is therefore classification is not justified.
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