Registration Dossier
Registration Dossier
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EC number: 288-309-9 | CAS number: 85711-49-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Fatty acids, coco, esters with oxybis(propanediol)
- EC Number:
- 288-309-9
- EC Name:
- Fatty acids, coco, esters with oxybis(propanediol)
- Cas Number:
- 85711-49-5
- Molecular formula:
- Not possible for UVCB
- IUPAC Name:
- Fatty acids, coco, esters with oxybis(propanediol)
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot No. of test material: 80118
- Expiration date of the lot/batch: 2018-10-18
- Purity test date: > 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in acetone, alcohol, oil and DMSO
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: InVivos Pte Ltd, Singapore
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Murine Pathogen Free (MPF)
- Age at study initiation: 8 weeks old on Day 1 induction
- Weight at study initiation: 16.5 - 20.2 g
- Housing: OptiMICE Caging Systems
- Diet (e.g. ad libitum): Altromin Maintenance Diet #1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: for at least 1 week
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100%, 50% and 25% (v/v) of the test item – Fatty acids, coco, esters with oxybis(propanediol)
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay: BrdU-ELISA
- Criteria used to consider a positive response: Based on OECD Guideline 442B, SI of 1.6 or more (≥ 1.6) is considered positive for designating a test sample as a sensitizer. The positive control usually produces a SI of ≥ 1.6.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substances were prepared by dissolving the test item in acetone : olive oil (4:1 v/v). Three concentrations 100%, 50% and 25% (v/v) were used in the study.
Negative control substance used in this study was acetone : olive oil (4:1 v/v).
The positive control substance used in the study was Hexylcinnamaldehyde (HCA) (CAS No 101-86-0). 50% (v/v) HCA in acetone : olive oil (4:1, v/v) was used in the study.
PREPARATION OF BRDU FOR INTRAPERITONEAL INJECTION: 5-bromo-2-deoxyuridine (BrdU) (CAS No 59-14-3) was dissolved in 0.9% NaCl saline for injection to a concentration of 10mg/ml, sterilized using a 0.2 µm syringe filtration unit and used for injection freshly.
Administration: Topical application on dorsum of both ears
Dose level: 25 µl for each ear
Dose Interval: Topical application of 25 µl of test substances/negative control/positive control on the dorsum of each ear once a day for 3 consecutive days - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Mean SI of the Positive Control group was 4.097 (>1.6).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 3.944
- Variability:
- 1.633
- Test group / Remarks:
- 100% test item
- Key result
- Parameter:
- SI
- Value:
- 4.761
- Variability:
- 1.670
- Test group / Remarks:
- 50% test item
- Key result
- Parameter:
- SI
- Value:
- 5.498
- Variability:
- 0.521
- Test group / Remarks:
- 25% test item
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the above study, using 100%, 50% and 25% (v/v) of the test item – Fatty acids, coco, esters with oxybis(propanediol) as test substances and acetone : Olive oil (4:1, v/v) as vehicle and negative control, skin sensitization was produced in mice.
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