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EC number: 211-669-5 | CAS number: 683-10-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- 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:
- 2 107
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Test Guideline 442E: human Cell Line Activation Test (h-CLAT)
- Version / remarks:
- adopted 29 Jul 2016. The study was performed using the h-CLAT method as detailed in OECD TG 442E and also in EURL ECVAM DB-ALM Protocol No. 158 (Issued 01 Jul 2015). Methodology is detailed in an XCellR8 SOP (L0094) that covers the h-CLAT. Study data is collected using XCellR8 internal protocols (IPs).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: In Vitro human Cell Line Activation Test (h-CLAT) method according to OECD Test Guideline 442E.
Test material
- Reference substance name:
- (carboxylatomethyl)dodecyldimethylammonium
- EC Number:
- 211-669-5
- EC Name:
- (carboxylatomethyl)dodecyldimethylammonium
- Cas Number:
- 683-10-3
- Molecular formula:
- C16H33NO2
- IUPAC Name:
- (carboxylatomethyl)dodecyldimethylammonium
- Test material form:
- solid
- Details on test material:
- Chemical Name Lauryl betaine
Physical State liquid - The sample was dried under a nitrogen purge to remove water prior to analysis.
CAS # 683-10-3
EU # 211-669-5
Manufacturer Colonial Chemical
Batch/lot # 53715J16
Received on November 22, 2016
Tested on January 31, 2017
Constituent 1
- Specific details on test material used for the study:
- Supplier Colonial Chemical
Test Item Name ColaTeric LAB-70UP; (1-Dodecanaminium, N-(carboxymethyl)-N,N-dimethyl-, inner salt)
Supplier Code Not provided
Supplier Batch/Lot Number 55880C17
CAS Number 683-10-3
Purity 30-32%
Expiry Date 10 Mar 2019 (from CofA)
Physical State Liquid, Clear
Storage Conditions Standard (10-49˚C, closed container)
Solubility Water
Results and discussion
- Positive control results:
- The CV75 (2,4-dinitrochlorobenzene (DNCB)) dose informs the dosing range selected for the CD54/86 (Nickel Sulphate) expression assay. However, in this case the highest possible dose was used which was equal to 5mg/ml (5000µg/ml). Note that Runs 4 and 5 used the same top dose however the dilution factor was adjusted (1 in 1.2 changed to 1 in 1.5) to give a greater dilution range with lower concentrations (below 1mg/ml at dilutions 5-8). This was due to low overall cell numbers observed when using high concentrations of the test item.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Parameter:
- other: EC200
- Value:
- 452
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Parameter:
- other: EC150
- Value:
- 469
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
As Runs 2 and 3 were invalid, a repeat run was carried out (Run 4). As Run 4 was not concordant with the result from Run 1, a final run (Run 5) was required to determine the test item classification. Runs 4 and 5 were both valid and concordant. As can be seen from the data, the expression of CD54 as measured by the RFI crossed the threshold (RFI ≥200) at 6/8 concentrations used in Run 4 and 7/8 in Run 5 (yellow highlighted cells). The expression of CD86 as measured by the RFI, crossed the threshold (RFI ≥150) at 6/8 concentrations used in Run 4 and 8/8 in Run 5 (green highlighted cells). As the CD54/CD86 expression crossed the threshold for both CD54 and CD86 at non-cytotoxic concentrations, the test item is classified as a Sensitiser. Cell viability did not fall below 50% at any of the test item concentrations and therefore the result is deemed to be valid.
For ColaTeric LAB-70UP; (1-Dodecanaminium, N-(carboxymethyl)-N,N-dimethyl-, inner salt) the dose that gave 75% cell viability could not be determined and therefore the maximal dose was used (5 mg/ml). The EC200 and EC150 values for CD54 and CD86 expression were 452 and 469 respectively, therefore,ColaTeric LAB-70UP; (1-Dodecanaminium, N-(carboxymethyl)-N,N-dimethyl-, inner salt)was classified as aSensitiseras per the prediction model
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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