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EC number: 267-041-6 | CAS number: 67763-18-2
- 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
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 15 Jun 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2002)
- Deviations:
- yes
- Remarks:
- no analytical purity/batch not reported
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- - Name of test material (as cited in study report): diisostearyl malate
- Physical state: viscous colourless liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- 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
- Weight at study initiation: 21.5 ± 1.3 g
- Housing: The animals were housed individually in disposable crystal polystyrene cages. Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet: A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test: 2.5, 5, 10 and 25%
Main test: 1, 2.5, 5, 10, 25% - No. of animals per dose:
- 1 (preliminary test)
4 (main test) - Details on study design:
- RANGE FINDING TESTS
- Compound solubility: highest concentration that was suitable for dosing: 25%
- Irritation: neither signs of systemic toxicity nor local skin irritation were observed up to the highest concentration of 25%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3Hmethyl-thymidine incorporation
- Criteria used to consider a positive response: The test item will be regarded as a sensitiser if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a “non-sensitiser”.
TREATMENT PREPARATION AND ADMINISTRATION
25 μL of the test item was applied to the dorsal surface of each ear of each mouse for three consecutive days; Further groups of four mice each received the vehicle or positive control alone in the same manner. Local irritation reactions were assessed. On day 6 an injection of 250 μL 0.9% NaCl containing 20 μCi of 3-Hmethyl-thymidine (3HTdR) was made into the tail vein of each experimental mouse. Five hours later, the draining auricular lymph node of each ear was excised and pooled for each experimental group. For each experimental group, a single cell suspension of auricular lymph node cells (ALNC) was prepared by mechanical dissagregation in Petri dishes with the plunger of a syringe. Cell suspensions were washed with 15 mL of 0.9% NaCl and pellets obtained were re-suspended in 0.9% NaCl for numeration of lymphocytes (cellularity) and determination of their viability by exclusion of trypan blue. Each cell suspension was then centrifuged and pellets were precipitated with 3 mL of 5% (w/v) trichloroacetic acid (TCA) in purified water at 4 °C overnight. After a last centrifugation, the pellets were precipitated with 1 mL of 5% TCA. Three mL of Ultima GoldxR scintillation fluid (Packard) were added in order to measure incorporation of 3HTdR using β-scintillation counting. The results were expressed as disintegration's/min (dpm) per group and per node. Stimulation Indices (SI) were calculated according to the formula: SI = dpm of treated group / dpm of control group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- A group of four animals was treated with 25 μL of the positive control substance α-hexylcinnamaldehyde (HCA) as a 25% solution in acetone/olive oil 4/1 (v/v). The stimulation index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is 6.72. Therefore, α-hexylcinnamaldehyde (HCA) was considered to be a sensitizer under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Test material concentrations of 1, 2.5, 5, 10 and 25% in acetone/olive oil (4/1 v/v) show stimulation indices (SI) of 1.21, 1.14, 1.32, 0.87 and 1.39, respectively. Based on this result, the test substance is considered as a non-sensitiser under the experimental conditions of the test.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The number of disintegrations per minute/node (dpm/node) for the vehicle was 45.30. Test material concentrations of 1, 2.5, 5, 10 and 25% in acetone/olive oil (4/1 v/v) show dpm/node of 54.93, 51.55, 59.87, 39.63 and 62.87, respectively.
Any other information on results incl. tables
Table 1: Experimental results of the LLNA assay
Concentration (% in v/v) acetone/olive oil (4/1) |
dpm/group |
dpm/node |
Stimulation index |
Result |
Vehicle |
362.40 |
45.30 |
NA |
NA |
1 |
439.41 |
54.93 |
1.21 |
Negative |
2.5 |
412.42 |
51.55 |
1.14 |
Negative |
5 |
478.97 |
59.87 |
1.32 |
Negative |
10 |
317.01 |
39.63 |
0.87 |
Negative |
25 |
502.98 |
62.87 |
1.39 |
Negative |
Positive control |
2436.56 |
304.57 |
6.72 |
Positive |
dpm: disintegration per minute
Systemic clinical signs and mortality
No clinical signs and no mortality were observed during the study.
Body weight
The body weight change of the treated animals was similar to that of the control animals.
Local irritation
No cutaneous reactions and no increase in ear thickness were observed at any tested concentration.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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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