Registration Dossier
Registration Dossier
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EC number: 211-669-5 | CAS number: 683-10-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- 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:
- 2107
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- not specified
- GLP compliance:
- yes
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:
- Sample details not specified in the report but it is ubderstood that the sample supplied was ColaTeric LAB, which is an aqueous solution of lauryl betaine in water at an active strength of 35%.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm system - cultured
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 microlitres of all articles.
- Duration of treatment / exposure:
- 35 +/- 1 minute @ 37C and then placed in a steril hood until the 60 minute exposure period was reached.
- Duration of post-treatment incubation (if applicable):
- 24 hours +/- 2 hours after washing.
- Number of replicates:
- Three
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 7.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- Value is 2.287 and lies between the range of >=0.8 - <=2.8 as per OECD 439
- Positive controls validity:
- valid
- Remarks:
- Value is 7.4% which is <=20% as required by the method
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Mean value of three test data gave a value of 7.8% mean issue viability in the EpiDerm skin test (OECD 439).
Accoridng to the test protocol, a value of <=50% predicts Irritant GHS Cat 2.
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