Registration Dossier
Registration Dossier
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EC number: 273-105-4 | CAS number: 68937-98-4 This substance is identified by SDA Substance Name: C14-C18 and C12-C20 unsaturated alkyl alkene and C14-C18 and C12-C20 unsaturated alkyl hydroxy sulfonic acid sodium salt and SDA Reporting Number: 03-059-04.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 August 2018 - 29 August 2018
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Version adopted 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Commission Regulation (EC) 400/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts
- EC Number:
- 273-105-4
- EC Name:
- Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts
- Cas Number:
- 68937-98-4
- IUPAC Name:
- Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Moisture content: 5% max
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: suspended solid floor polypropylene cages furnished with softwood flake bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: None indicated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): At least fifteen
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
- IN-LIFE DATES: From: 15 August 2018 To: 29 August 2018
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% Pluronic in distilled water
- Concentration:
- 5, 10, and 25% (w/w)
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Solubility was assessed in acetone / olive oil (4:1), dimethyl formamide, butanone, dimethyl sulphoxide, acetone, 1% Pluronic L92 in distilled water, ethanol / water (7:3) and propylene glycol. 1% pluronic in water was found to be the only solvent which formed a solution suitable for dosing.
- Irritation: A 25% solution of the test material in the vehicle was found not to cause local skin irritation (observation for 6 days after start of exposure)
- Systemic toxicity: No indication of systemic toxicity
- Ear thickness measurements: Mean change in ear thickness of 23.81% during the 6 days over which measurements were taken. As the change was less than 25% this was concluded not to indicate irritation - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.38
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 3.27
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 4.97
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- EC3
- Value:
- 9.3
- Cellular proliferation data / Observations:
- 5%, Stimulation Index = 1.38
10%, Stimulation Index = 3.27
25%, Stimulation Index = 4.97
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item was considered to be a sensitizer under the conditions of the test.
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