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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- Soybean oil, epoxidized, acrylate
- EC Number:
- 294-415-6
- EC Name:
- Soybean oil, epoxidized, acrylate
- Cas Number:
- 91722-14-4
- Molecular formula:
- C63H108O15
- IUPAC Name:
- Soybean oil, epoxidized, acrylate
- Details on test material:
- - Name of test material (as cited in study report): Epoxidized Soybean Oil Acrylate
- Substance type: UVCB
- Physical state: yellow viscous liquid
- Analytical purity: 100 %
- Lot/batch No.: S702300037
- Expiration date of the lot/batch: 31 December 2012
- Storage condition of test material: Room temperature (15-25 oC, below 70 RH%)
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (LLNA)
- 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)
Results and discussion
- 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.
In vivo (LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
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.