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Toxicological information

Skin irritation / corrosion

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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:
2017
Report date:
2017

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

Constituent 1
Reference substance name:
Reaction mass of N,N-Bis(2-hydroxypropyl)(C6-C18 even numbered and C18 unsatd)amides and bis(2-hydroxypropyl)ammonium myristate
Molecular formula:
No molecular formula. UVCB reaction mass.
IUPAC Name:
Reaction mass of N,N-Bis(2-hydroxypropyl)(C6-C18 even numbered and C18 unsatd)amides and bis(2-hydroxypropyl)ammonium myristate
Test material form:
liquid
Specific details on test material used for the study:
ColaLiquid DC-5, 100% active

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:
78.3
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:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Mean value of three test data gave a value of 78.3% mean issue viability in the EpiDerm skin test (OECD 439).
Accoridng to the test protocol, a value of >50% predicts Non-Irritant under GHS classification