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EC number: 285-107-2 | CAS number: 85029-82-9
- 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 (non-LLNA)
- Remarks:
- Modified Buehler Method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11mApr 2017 Experimental starting date (Primary Irritation Phase – animals shaved) to 01 Jun 2017 Experimental termination (completion) date (scheduled euthanasia)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- EPA OPPTS Guideline 870.2600 OECD Guideline 406
EEC Guideline 92/69, Annex V, B6 - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The substance is surface active and can form micelles. Surface active materials have been demonstrated to induce false positive responses in the LLNA but not in standard guinea-pig assays. The Buehler method is more humane than the Magnusson-Kligman maximisation test, and therefore it was selected for use to evaluate this substance instead of the LLNA.
Test material
- Reference substance name:
- Soybean oil, maleated, ester with triethanolamine
- EC Number:
- 285-107-2
- EC Name:
- Soybean oil, maleated, ester with triethanolamine
- Cas Number:
- 85029-82-9
- Molecular formula:
- C63H113NO12 to C67H123NO12
- IUPAC Name:
- Soybean oil, maleated, ester with triethanolamine
- Test material form:
- other: Clear amber viscous liquid
- Details on test material:
- 100% product
Physical state/Appearance: Clear amber viscous liquid
Expiry Date: 24 June 2018
Storage Conditions: Room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
Exp. date: 17 Feb 2019
[ID No. 170071]
Brown, translucent, viscous liquid
Date of Receipt 23 Feb 2017
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Hartley (Crl:HA) albino guinea pigs
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Hartley (Crl:HA) albino guinea pigs were used as the test system on this study. The animal model, the Hartley albino guinea pig, is generally recognized as appropriate for skin sensitization studies. The number of animals selected for this study (4 animals/sex for the Primary Irritation Group, 10 animals/sex/group for the Test Group, 5 animals/sex for the Naïve Control-I Group, and 5 animals/sex for the Positive Control Group) was the number required to satisfy regulatory guidelines.
The albino guinea pigs utilized for this study were received in good health from Charles River Laboratories, Inc., Stone Ridge, NY. The guinea pigs were inspected by a qualified technician upon receipt, weighed, and uniquely identified by a cage card displaying the animal number.
The guinea pigs were acclimated to laboratory conditions for a minimum of 5 days. During the acclimation period, the guinea pigs were observed twice daily for mortality and moribundity.
All animals were housed throughout the acclimation period and during the study in an environmentally controlled room. The room temperature and humidity controls were set to maintain environmental conditions of 68 °F to 78°F (20°C to 26°C) and 30% to 70%, respectively. Room temperature and relative humidity data were monitored continuously and were scheduled for automatic collection on an hourly basis. These data are summarized in Appendix 3. Actual mean daily temperature ranged from 72.5°F to 73.3°F (22.5°C to 22.9°C) and mean daily relative humidity ranged from 44.6% to 52.9% during the study. Fluorescent lighting provided illumination for a 12-hour light (0600 hours to 1800 hours)/12-hour dark photoperiod. Lighting conditions were recorded every 15 minutes. The 12-hour light/12-hour dark photoperiod was interrupted if necessary to allow for the performance of protocol-specified activities. Air handling units were set to provide a minimum of 10 fresh air changes per hour
Upon arrival, all animals were housed in individual suspended wire-mesh cages. The animals were maintained by the animal husbandry staff of Charles River in accordance with SOPs.
Animals were maintained in accordance with the Guide for the Care and Use of Laboratory Animals.2 The animal facilities at Charles River Ashland are accredited by AAALAC International. Enrichment devices were provided to all animals as appropriate throughout the study for environmental enrichment and to aid in maintaining the animals’ oral health, and were sanitized weekly.
The basal diet used in this study, PMI Nutrition International, LLC, Certified Guinea Pig LabDiet® 5026, is a certified feed with appropriate analyses performed by the manufacturer and provided to Charles River. Municipal water supplying the facility was analyzed for contaminants according to Charles River SOPs. The results of the diet and water analyses are maintained at Charles River. No contaminants were present in animal feed or water at concentrations sufficient to interfere with the objectives of this study. The basal diet and municipal water, delivered by an automatic watering system, were provided ad libitum throughout the acclimation period and during the study.
Animals used on the Primary Irritation Phase were arbitrarily selected from available stock. Animals used in the main study were selected from available stock and assigned to groups by stratified randomization through use of WTDMS™. The selected animals were young adult; body weight values ranged from 473 g to 655 g for males and from 398 g to 554 g for females at randomization excluding Primary Irritation Phase animals (see Appendix 1 - Study Protocol and Deviations).
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- 100% Test Substance
- Concentration / amount:
- 100% Test Substance
- Day(s)/duration:
- 3 induction doses spaced 1 week apart over a period of 3 weeks
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- The Challenge Phase consisted of a single application of the maximal nonirritating concentration of test substance to determine if delayed contact hypersensitivity had occurred.
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 4 animals / sex for the Primary Irritation Group, 10 animals / sex / group for the Test Group, 5 animals / sex for the Naïve Control-I Group, and 5 animals / sex for the Positive Control Group
- Details on study design:
- The positive control substance was α-hexylcinnamaldehyde (HCA) (Lot No. MKBT2800V, exp. date: 25 Nov 2020).
Acetone, NF (Lot No. 2EL0104, exp. date: 03 Dec 2020) and polyethylene glycol (PEG) 400, NF (Lot No. 2EI0410, retest date: 19 Jun 2018) were used to prepare the HCA formulations for the Challenge and Rechallenge Phases.
Primary Irritation Phase
The test substance was prepared for dosing the Primary Irritation Phase as weight-to-volume (w/v) mixtures in propylene glycol (Lot No. 165702, retest date: 30 Sep 2019) at concentrations of 1%, 2.5%, 5%, 10%, 25%, 50%, 75%, and 100%. The appropriate amount of test substance for each concentration was weighed and vehicle was added in sufficient quantity to obtain the desired concentrations. Sufficient undiluted test substance was also dispensed for dosing.
Induction Phase
Sufficient amounts of undiluted test substance and undiluted positive control substance were dispensed for induction dosing.
Challenge Phase
A sufficient amount of undiluted test substance was dispensed for the Test Group and Naïve Control-I Group. - Challenge controls:
- The Challenge Phase consisted of a single application of the maximal nonirritating concentration of test substance to determine if delayed contact hypersensitivity had occurred.
Two weeks after the final induction dose, undiluted test substance was administered to previously unexposed sites on the posterior left flank of the Test and Naïve Control-I Group
animals at 0.3 mL/site. For the Positive Control Group, 10% and 20% concentrations of HCA in 70% acetone/30% PEG 400 were administered to previously unexposed sites on the posterior left and right flanks, respectively, at 0.3 mL/site. Doses were applied under 25-mm Hill Top Chambers® that were occluded with plastic wrap and overwrapped with nonirritating elastic tape. All challenge exposures were approximately 6 hours, after which the bandages were removed and the sites wiped with disposable paper towels moistened with propylene glycol (see
Appendix 1 - Study Protocol and Deviations). On the following day, at least 3 hours prior to the 24-hour scoring, the hair was carefully clipped with an electric shaver from the dosing area of each animal.
One week after the initial challenge, a rechallenge was performed in which the positive control substance (10% and 20% concentrations of HCA in 70% acetone/30% PEG 400) was administered to previously unexposed sites on the middle right and left flanks, respectively, at
0.3 mL/site (see Appendix 1 - Study Protocol and Deviations). Doses were applied under 25-mm Hill Top Chambers® that were occluded with plastic wrap and overwrapped with
nonirritating elastic tape. All rechallenge exposures were approximately 6 hours, after which the bandages were removed and the sites wiped with disposable paper towels moistened with propylene glycol (see attached Appendix 1 - Study Protocol and Deviations). - Positive control substance(s):
- yes
- Remarks:
- The positive control substance was α-hexylcinnamaldehyde Acetone, NF & polyethylene glycol, retest date: 19 Jun 2018) were used to prepare the HCA formulations for the Challenge and Rechallenge Phases.
Results and discussion
- Positive control results:
- The concentration used at challenge for the Positive Control Group was a known non-irritating concentration; therefore, grades of 1 or greater in the Positive Control Group indicated sensitization responses.
The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge Dosing
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge Dosing
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% HCA
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- other: See remarks
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% HCA
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- other: See remarks
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20% HCA
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- other: See remarks
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20% HCA
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- other: See remarks
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% HCA
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% HCA
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20% HCA
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20% HCA
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- There were no clinical findings observed during the study.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design
Any other information on results incl. tables
There were no deaths during the study.
There were no clinical findings observed during the study.
There were no remarkable body weight changes noted during the study.
Dermal Observations and Severity Indices
Data: see attached Table 3, Table 6, Table 7, Table 8, Table 9, Table 10
Text Table 5 Challenge Dosing
Group |
Material |
Dermal Scores |
Severity Index |
Incidence Index |
||||||||||
24-hour |
48-hour |
24-hour |
48-hour |
|||||||||||
0 |
± |
1 |
2 |
3 |
0 |
± |
1 |
2 |
3 |
|||||
Test |
100 % OS200034M |
19 |
1 |
0 |
0 |
0 |
19 |
1 |
0 |
0 |
0 |
0.0 |
0.0 |
0% |
NaïveControl-I |
100 % OS200034M |
10 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
0.0 |
0.0 |
NA |
Positive Control |
10% HCA |
7 |
3 |
0 |
0 |
0 |
9 |
1 |
0 |
0 |
0 |
0.2 |
0.1 |
0% |
Positive Control |
20% HCA |
3 |
7 |
0 |
0 |
0 |
7 |
3 |
0 |
0 |
0 |
0.4 |
0.2 |
0% |
Text Table 6 Rechallenge Dosing
Group |
Material |
Dermal Scores |
Severity Index |
Incidence Index |
||||||||||
24-hour |
48-hour |
24-hour |
48-hour |
|||||||||||
0 |
± |
1 |
2 |
3 |
0 |
± |
1 |
2 |
3 |
|||||
Positive Control |
10% HCA |
3 |
5 |
2 |
0 |
0 |
4 |
6 |
0 |
0 |
0 |
0.5 |
0.3 |
20% |
Positive Control |
20% HCA |
0 |
5 |
5 |
0 |
0 |
4 |
3 |
3 |
0 |
0 |
0.8 |
0.5 |
80% |
Based on the severity and incidence indices for the Test Group, there was no indication of a sensitization response following the challenge dosing. Therefore, a rechallenge was not warranted for the Test Group.
The concurrent Positive Control Group exhibited an incidence index of 0% following the challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the Positive Control Group. Following rechallenge, the positive control article, HCA, was a sensitizer when administered as both a 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Under the conditions of this study the test item was a non-sensitizer in albino guinea pigs.
- Conclusions:
- Under the conditions of this study the test item was a non-sensitizer in albino guinea pigs.
- Executive summary:
Objective
The objective of this study was to determine the ability of the test item to induce delayed contact hypersensitivity when applied in close contact to the skin of albino guinea pigs.
Study Design
The sensitization potential of the test item was evaluated in this modified Buehler method dermal sensitization study.
A Test Group of 10 male and 10 female Hartley (Crl:HA) albino guinea pigs was dosed topically with the test substance 1 time per week for 3 weeks for a total of 3 induction exposures. The duration of each exposure was 6 hours. Approximately 2 weeks after the last induction exposure, the animals were challenge-dosed for detection of sensitization by topical application of the test substance to a previously unexposed area of skin. The test substance, was administered at a concentration of 100% (Induction and Challenge).
A Naïve Control-I Group of 5 male and 5 female guinea pigs was dosed with the test substance in the challenge phase in the same manner as the Test Group and served as an irritation control.
A Positive Control Group of 5 male and 5 female guinea pigs was included to demonstrate the reliability of the experimental design. The Positive Control Group was induced and challenged on a similar regimen as the Test Group. The positive control material, α-hexylcinnamaldehyde (HCA), was administered at a concentration of 100% (Induction) and at concentrations of
10% and 20% (Challenge) prepared v/v in 70% acetone/30% PEG 400. Seven days after challenge dosing, Positive Control Group animals were rechallenged to support the initial challenge results.
Reactions to challenge and rechallenge dosing were evaluated at approximately 24 and 48 hours after completion of exposure. Body weights and clinical observations were recorded at randomization (Study Day -1) and at study termination (Study Day 34 or 37).
Prior to conducting the induction and challenge phases of the study, 4 male and 4 female guinea pigs were dosed to determine the appropriate concentrations of test substance to be used for dosing.
Results
There were no deaths, test substance-related clinical findings, or remarkable body weight changes during the study period. The Incidence Index for the Test Group was 0% (0/20) following challenge dosing.
Conclusions
Under the conditions of this study, the test item was a non-sensitizer in albino guinea pigs.
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