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EC number: 294-415-6 | CAS number: 91722-14-4
- 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: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June-August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been conducted according to OECD Guideline No. 429 and under GLP.
- 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:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species and strain: CBA/J Rj mice
- Source: ELEVAGE JANVIER
Route des Chènes Secs B.P. 4105
53940 LE GENEST-ST-ISLE, France
- Age at study initiation: 11 weeks old
- Weight at study initiation: 20.3 – 22.5 grams
- Housing: Group caging / mice were provided with glass tunnel-tubes. Cage type: Type II. polypropylene/ polycarbonate
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: 20 June 2012 To: 26 June 2012 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- The Preliminary Irritation/Toxicity Test was performed in CBA/J Rj mice using two doses (test item concentrations of 50 and 25% (w/v)) in the selected vehicle. The observations recorded in the preliminary test suggest that the 50% (w/v) formulation is a suitable maximum dose level for a valid LLNA.
In the main test, groups of four female CBA/J Rj mice were treated with: 50, 25 and 10% (w/v) of the test substance in AOO. - No. of animals per dose:
- 4 females per dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: acetone/olive oil (4:1 v/v) used as vehicle
- Irritation: The Preliminary Irritation/Toxicity Test was performed in CBA/J Rj mice using two doses (test item concentrations of 50 and 25% (w/v)) in the selected vehicle. The observations recorded in the preliminary test suggest that the 50% (w/v) formulation is a suitable maximum dose level for a valid LLNA.
MAIN TEST
TREATMENT PREPARATION AND ADMINISTRATION:
In the main test, groups of four female CBA/J Rj mice were treated with: 50, 25 and 10% (w/v) of the test substance in AOO. The solutions of the test substance were applied on the dorsal surface of ears of experimental animals (25 µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- α-Hexylcinnamaldehyde (25% (w/v) dissolved in AOO) was used as a positive control. A significant lymphoproliferative response (stimulation index value of 6.8) was noted for the positive control chemical and this result confirmed the validity of the assay.
- Parameter:
- SI
- Remarks on result:
- other: Stimulation index values of the test substance were 2.6, 1.0 and 0.4 at treatment concentrations of 50, 25 and 10% (w/v), respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test Group Measured Group No. of DPN Stimulation Name DPM/group DPM Nodes Index Values Background (5 (w/v) % TCA ) 35.5 - Negative control AOO 1891 1855.5 8 231.9 1.0 Epoxidized Soybean Oil Acrylate 50% (w/v) in AOO 4825 4789.5 8 598.7 2.6 Epoxidized Soybean Oil Acrylate 25% (w/v) in AOO 1882 1846.5 8 230.8 1.0 Epoxidized Soybean Oil Acrylate 10% (w/v) in AOO 727 691.5 8 86.4 0.4 Positive control 25 % HCA in AOO 12703 12667.5 8 1583.4 6.8
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance did not have a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
- Executive summary:
The aim of this study was to determine the skin sensitisation potential of test substance following dermal exposure.
The test subtance was soluble in acetone/olive oil (4:1 v/v) (abbreviation: AOO).The test item formed an applicable solution in AOO at 50% (w/v),therefore it was chosen as vehicle for the test. The test item is very viscousliquid at room temperature, which is not applicable undiluted. The Preliminary Irritation/Toxicity Test was performed in CBA/J Rj mice using two doses (test item concentrations of 50 and 25% (w/v)) in the selected vehicle. The observations recorded in the preliminary test suggest that the 50% (w/v) formulation is a suitable maximum dose level for a valid LLNA.
In the main test, groups of four female CBA/J Rj mice were treated with: 50, 25 and 10% (w/v) of the test substance in AOO. The solutions of the test substance were applied on the dorsal surface of ears of experimental animals (25 µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).
No mortality or sign of systemic toxicity or local irritation were observed during the study. No treatment related effects were observed on animal body weights in any treated groups. The observed clinical signs are summarized in Appendix 3. Stimulation index values of the test substance were 2.6, 1.0 and 0.4 at treatment concentrations of 50, 25 and 10% (w/v), respectively.
α-Hexylcinnamaldehyde (25% (w/v) dissolved in AOO) was used as a positive control to demonstrate the appropriate performance of the assay [1]. A significant lymphoproliferative response (stimulation index value of 6.8) was noted for the positive control chemical and this result confirmed the validity of the assay.
In conclusion, under the conditions of the present assay, the test substance did not have a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance did not show any skin sensitising properties in the Local Lymph Node Assay. There is no reason to believe that results obtained in the Local Lymph Node Assay would not be applicable to humans.
Migrated from Short description of key information:
The test substance is not a sensitiser in the Local Lymph Node Assay.
Justification for selection of skin sensitisation endpoint:
There is only one skin sensitisation study available. This study has been conducted according to OECD guideline no. 429 and under GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerge, this will be taken into account.
Migrated from Short description of key information:
There is no relevant information available for respiratory sensitisation.
Justification for classification or non-classification
The test substance is not a sensitiser in the Local Lymph Node Assay. Therefore, there is no need to classifiy the substance for skin sensitisation, according to the Regulation EC 1272/2008 and the Directive 67/584/EEC.
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