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EC number: 614-947-8 | CAS number: 693217-63-9
- 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:
- 19 February to 27 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to a recognised OECD protocol with no significant deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Soybean oil, reaction products with ethaneperoxoic acid
- Cas Number:
- 693217-63-9
- Molecular formula:
- C59 H106 O11
- IUPAC Name:
- Soybean oil, reaction products with ethaneperoxoic acid
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Agrol® 3.6 Soy-Based Polyol
- Substance type: UVCB
- Physical state: Liquid
- Lot/batch No.: 13-3.6-ASO-004
- Expiration date of the lot/batch: Given as 360 days from date of analysis: 8 February 2013
- Storage condition of test material: Ambient temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley; Indianapolis, IN
- Age at study initiation: 8 weeks
- Weight at study initiation: 21.3 - 24.3 g
- Housing: Polycarbonate boxes with bedding; 1-5 per cage
- Diet (e.g. ad libitum): PMI Feeds Inc.™ Formulab #5008; available ad libitum
- Water (e.g. ad libitum): Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system
- Acclimation period: Not given.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 28-79%
- Air changes (per hr): 10+ air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: From: 20 March 2013 To: 25 March 2013
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100%; 50% and 25% in 4:1 acetone:olive oil
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS: N/A
- Compound solubility:
- Irritation:
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Liquid scintillation counting/disintegrations per minute
- Criteria used to consider a positive response: Positive control test item produced a stimulation index > 3, and is therefore considered a sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION:
Healthy mice were released from quarantine prior to testing. Five females were selected for each of three Test groups (Groups I - III). On Days 1, 2 and 3, each Test animal in its group received an open application of 25 μL of appropriate dilution (25 or 50%) of test item, or 100% test item undiluted, to the dorsum of both ears. The Vehicle Control group (5 females) was treated the same way as test animals, but with vehicle alone instead of test item. The Positive Control group (5 females) was treated with 100% alpha-hexylcinnamaldehyde. All Test and Control animals were given a two-day rest period on Days 4 and 5.
On Day 6 of the study, all Test and Control animals were injected in the tail vein with 250 μL of 0.01 M phosphate-buffered saline (PBS; Sigma, Lot 081M8207, Exp Nov 2021), pH 7.4 at 25oC per manufacturer, containing 20 μCi of [methyl-3H] Thymidine (PerkinElmer, Lot 201303, Exp Mar 2014). Five hours after injection, animals were sacrificed with an overdose of CO2, the draining auricular lymph nodes excised and pairs from each individual animal processed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No statitical analyses were performed on the data.
Results and discussion
- Positive control results:
- Animal number DPM Count
1 8290.0
2 7585.7
3 3320.8
4 5718.7
5 8876.5
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: See table below.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table below.
Any other information on results incl. tables
Animal Group | Test Item Concentration | Average Count per Mouse | Number of Mice in Group | Stimulation Index |
Vehicle control | N/A | 622 | 5 | N/A |
Test Group I | 25% | 655 | 5 | 1.1 |
Test Group II | 50% | 414 | 5 | 0.7 |
Test Group III | 100% | 749 | 5 | 1.2 |
Positive control | N/A | 6758 | 5 | 10.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Agrol® Polyol (CAS 693217-63-9) produced a stimulation index < 3 in all groups of Test animals, and is not therefore considered a sensitizer (defined as producing a positive response).
- Executive summary:
A skin sensitization study was conducted on 3 groups of 5 female mice to determine if test item Agrol® Polyol (CAS 693217-63-9) possesses a significant potential to cause skin sensitization. Five females were assigned to each of three groups, designated Groups I - III. Test groups were treated with an appropriate dilution (25 or 50%) in 4:1 acetone:olive oil, or 100% test item. Each animal received 25 μL to the dorsum of each ear. Animals were treated once daily for three days. After a two-day rest period, all animals were injected with tritiated methyl-thymidine in the tail vein. Five hours later, animals were sacrificed, and the draining auricular lymph nodes removed and prepared for cell suspension and scintillation counting. A Vehicle Control group of five females was run concurrently, treated in the same manner with vehicle only instead of test item or dilution. A Positive Control group of five females was also run concurrently, treated with 100% alpha-hexylcinnamaldehyde. The test item produced a stimulation index
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