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EC number: 696-271-3 | CAS number: -
- 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
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Start Date: January 16, 2012 End Date: February 24, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed accrding to recognised method, and conducted in accordance with the Declaration of Helsinki, the ICH. Guideline E6 for Good Clinical Practice, and the testing company's Standard Operating Procedures, and approved protocol.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- This trial has been conducted in accordance with the Declaration of Helsinki, the ICH. Guideline E6 for Good Clinical Practice, the requirements of 21 CFR Parts 50 and 56, other applicable laws and regulations, the testing company's Standard Operating Procedures, and the approved protocol.
- GLP compliance:
- no
- Remarks:
- Not GLP study. Trial conducted according to the Declaration of Helsinki, the ICH. Guideline E6 for Good Clinical Practice, 21 CFR Parts 50 and 56, other applicable laws and regulations, the testing company's SOPs, and the approved protocol.
- Type of study:
- other: Repeat Insult Patch Test
- Species:
- human
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Participants:
Fifty-six (56) qualified subjects, male and female, ranging in age from 18 to 67 years, were selected for this evaluation. Fifty-one (51) subjects completed this study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
Inclusion Criteria:
a. Male and female subjects, age 16 (with parental or guardian consent) and over.
b. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
d. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e. Considered reliable and capable of following directions.
Exclusion Criteria:
a. Ill health.
b. Under a doctors care or taking medications) which could influence the outcome of the study.
c. Females who are pregnant or nursing.
d. A history of adverse reactions to cosmetics or other personal care products. - Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (ca. 2ml)
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (ca. 2ml)
- No. of animals per dose:
- 56 (51 completed study)
- Details on study design:
- Methodology:
The upper back between the scapulae served as the treatment area. Approximately 2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to the 1x1 absorbent pad portion of a clear adhesive dressing. This was then applied to the appropriate treatment site to form a semi-occlusive patch.
Induction Phase:
Patches were applied three (3) times per week (e.g., Monday, Wednesday, and Friday) for a total of nine (9) applications. The site was marked to ensure the continuity of patch application. Following supervised removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty-four hours after application. The evaluation of this site was made again just prior to reapplication. If a participant was unable to report for an assigned test day, one (1) makeup day was permitted. This day was added to the induction period.
With the exception of the first supervised induction Patch reading, if any test site exhibited a moderate (2-level) reaction during the Induction Phase, application was moved to an adjacent area. Applications were discontinued for the remainder of this test phase, if a moderate (2-level) reaction was observed on this new test site. Applications would also be discontinued if marked (3-level) or severe (4-level) reactivity was noted.
Rest periods consisted of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal.
Challenge Phase:
Approximately two (2) weeks after the final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site, following the same procedure described for Induction, The patch was removed and the site scored at the clinic twenty-four and seventy two hours post-application.
Evaluation Criteria (Erythema and additional Dermal Sequelae):
0 = No visible skin reaction
0.5 = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
E = Edema
D = Dryness
S Staining
P = Papules
V Vesicles
B = Bullae
U = Ulceration
Sp = Spreading
Erythema was scored numerically according to this key. If present, additional Dermal Sequelae were indicated by the appropriate letter code and a numerical value for severity. - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- ca 2ml (100%)
- No. with + reactions:
- 0
- Total no. in group:
- 51
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: ca 2ml (100%). No with. + reactions: 0.0. Total no. in groups: 51.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- ca 2ml (100%)
- No. with + reactions:
- 0
- Total no. in group:
- 51
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: ca 2ml (100%). No with. + reactions: 0.0. Total no. in groups: 51.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Observations remained negative throughout the test interval.
Under the conditions of this study, test material, Coco-Oleic Estolide Ester DI, did not indicate a potential for dermal irritation or allergic contact sensitization.
Reference
The results of each participant are appended, see table below.
Observations remained negative throughout the test interval.
Under the conditions of this study, test material, Coco-Oleic Estolide Ester DI, did not indicate a potentioal for dermal irritation or allergic contact sensitisation.
Subject Number | Initials | Age | Sex | 24*hr | Induction Phase | Virgin Challenge Site | |||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 24*hr | 72 hr | |||||
1 | TLH | 49 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | J-G | 48 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | MJM | 27 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | DML | 48 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | DAJ | 55 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | J-G | 61 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | DPI | 46 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
8 | IMZ | 61 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
9 | A-V | 33 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10 | MMA | 49 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
11 | NIB | 42 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
12 | A-G | 51 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
13 | MPB | 45 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
14 | M-J | 56 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
15 | KLR | 56 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
16 | LAV | 64 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
17 | L-M | 54 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
18 | C-V | 34 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
19 | CVC | 37 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
20 | MGC | 38 | F | 0 | 0 | 0 | DID NOT COMPLETE | ||||||||
21 | C-V | 65 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
22 | LMF | 67 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
23 | AAK | 20 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
24 | Y-F | 47 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | CAB | 18 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
26 | P-S | 34 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
27 | CEG | 57 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
28 | R-Z | 46 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
29 | JAR | 66 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
30 | J-R | 32 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
31 | AMC | 39 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
32 | DMC | 47 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
33 | LBB | 59 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
34 | CLH | 51 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
35 | RLD | 33 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
36 | SAM | 33 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
37 | MSC | 23 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
38 | RMM | 39 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
39 | A-T | 33 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
40 | N-C | 55 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
41 | SBC | 53 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
42 | TAW | 43 | F | 0 | DID NOT COMPLETE | ||||||||||
43 | M-V | 57 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
44 | ABJ | 22 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
45 | SEW | 23 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
46 | MMM | 59 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
47 | TAW | 46 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
48 | SBW | 26 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
49 | RLB | 36 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | SLA | 37 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
51 | TSC | 23 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
52 | R-P | 23 | M | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
53 | ECM | 19 | M | DID NOT COMPLETE | |||||||||||
54 | ASH | 19 | M | DID NOT COMPLETE | |||||||||||
55 | SEE | 20 | F | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
56 | KRS | 20 | F | 0 | 0 | DID NOT COMPLETE | |||||||||
24* = Supervised removal of 1st induction and challenge patch |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Migrated from Short description of key information:
In a study of 56 voulenteers in which 51 completed the trial, no adverse effects were seen relating to the test item.
Justification for selection of skin sensitisation endpoint:
HRIPT selected due to the good quality of the data, but also with regard to the questionable efficacy in assessment via the LLNA study, as highlighted by the available published knowledge on similar such substances.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
No study available
Justification for classification or non-classification
In the weight of evidence submitted, two studies specifically have been reported, An LLNA performed in 2013, and a HRIPT study, carried out in 2012. The classification has been determined based on the results of the HRIPT, with due recognition of the results highlighted in the LLNA study, which have been disregarded due to the reasons elaborated below regarding calculation of the Stimulation Index in the study.
In accordance with the findings of the Human Repeat Insult Patch test, the substance is considered not classified for skin sensitisation.
HRIPT - CPTC (2012)
This study was carried out with the aid of 56 volunteers, 51 of whom went on to complete the trail, 5 did not continue their participation for reasons unrelated to the application of the test substance.
During the course of the study, no adverse effects were observed or reported, allowing for the conclusion that the substance was not a skin sensitiser.
LLNA - MB Research Laboratories (2013)
In the in vitro LLNA study provided a stimulation index of 2.8 was reported, highlighting a potential for skin sensitisation. However, whereas the study was reportedly conducted in accordance with OECD 442B, the results have not been calculated in accordance with the guideline.
The Stimulation Index (SI) for the 100% test item-treated group was calculated to be 2.8 (hence the ‘positive’ result). This was derived by dividing the mean optical density of the 100% test-item treated group by the mean optical density of the naïve (sham treated) group. However, according to OECD test guideline 442B, paragraph 30, “The SI is derived by dividing the mean BrdU labelling index/mouse within each test substance group, by the mean BrdU labelling index for the solvent/VC group.” Note, the solvent/vehicle control group, not the naïve (sham treated) group. The SI for the 100% test item-treated group, if calculated according to OECD 442B is 1.44 (0.243/0.169) which will be below the 1.6 threshold and therefore highlights a negative result.
See the table below for mean values recalculated using the method prescribed in OECD 442B, and the values reported in the table of Stimulation Index Values from the study summary.
Treatment | Mean OD | SI |
AOO (Vehicle Control) |
0.169 | |
25% HCA (Positive Control) |
0.314 | 1.86 |
25% (v/v) CAS# 1365345-64-7 (SE7B Batch 2137-0) |
0.159 | 0.94 |
50% (v/v) CAS# 1365345-64-7 (SE7B Batch 2137-0) |
0.167 | 0.99 |
100% (v/v) CAS# 1365345-64-7 (SE7B Batch 2137-0) |
0.243 | 1.44 |
Kreiling et al (2008) and Ball, N et al (2011)
These papers has been included to highlight the uncertainty of LLNA studies performed on several surfactants in one and several unsaturated compounds in the other (which share similar properties to the test substance) albeit in accordance with OECD 429 rather than 442B.
The report shows a significant potential for LLNA studies in such materials to provide positive results which are at odds with several other recognised test methods, assays and structural alerts. These have been included to add weight to the argument that the result of the HRIPT should be given merit over the LLNA performed according to 442B.
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