Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2107

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
Specific details on test material used for the study:
Sample details not specified in the report but it is understood 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).
According to the test protocol, a value of <=50% predicts Irritant GHS Cat 2.