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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following in-vitro guideline performed on a similar substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Principles of method if other than guideline:
Dermal Irritection Assay System (refinement of the former Skintex method).It is an in-vitro irritation prediction method that uses non-human substrates as a biomembrane barrier macromolecular matrix system. In particular former Skintex (TM) used a two-compartment physico-chemical model incorporating a keratine/collagen membrane barrier and an ordered macromolecular matrix. When irritating agents are applied to the matrix of the test, they produce effects as they produce nucleation of particles that make the matrix cloudy proportionally with the aggressiveness of the substance. This phenomenon can be quantified with an optical density spectrophotometer measurement, that according to the protocol, is revelead at 450 nm. Due to the fact that the exposure time is a critical point, a semi-permeable membrane with tailored porosity is used which allows to clearly detect the maximum opacification point. A direct correlation between the Patch test and the scale determined with Dermal Irritection protocol was also determined and used for quantification of the results.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction products of fatty acids, C12-14 (even numbered) alkyl and triglycerides, C16 and C18 (unsaturated) alkyl with 2-(2-aminoethylamino)ethanol and sodium chloroacetate
EC Number:
942-589-5
Molecular formula:
not applicable
IUPAC Name:
Reaction products of fatty acids, C12-14 (even numbered) alkyl and triglycerides, C16 and C18 (unsaturated) alkyl with 2-(2-aminoethylamino)ethanol and sodium chloroacetate
Details on test material:
The substance was used either as dehydrated sample (for phys-chem properties) or as solution at 30% (for in vitro skin irritation)

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: opacity
Remarks on result:
other: results are reported in the relevant section

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Conclusions:
The substance was tested for skin irritation by means of Dermal Irritection Assay. Under the experimental conditions the substance showed slight skin irritation properties.
Executive summary:

The substance was tested for skin irritation by means of Dermal Irritection Assay. Under the experimental conditions the substance showed slight skin irritation properties.