N-dodecyl-β-alanine, compound with 2,2',2''-nitrilotriethanol (1:1)

Skin irritation / corrosion

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 with acceptable restrictions

Justification for type of information:

Performed on sodium salt.
Triethanolamine is not irritating to skin

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

EC 290-476-8

IUPAC Name:

EC 290-476-8

Test material form:

solid: compact

Details on test material:

As the substnace is normally supplied in water as 30 - 40 % solution, material was dried specifically for testing.

Specific details on test material used for the study:

Sodium salt tested.
Triethanolamine is non-irritant.

In vitro test system

Test system:

human skin model

Source species:

human

Vehicle:

water

Control samples:

yes, concurrent positive control

Test system

Details on study design:

The principle of the assay is based on the measurement of cytotoxicity in reconstructed
human epidermal cultures following topical exposure to the test item by means of the
colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of
the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium
bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test item
treated tissues relative to the negative controls.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1

Value:

> 100

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The relative mean viability of the test item treated tissues was 112.6% after a 15-Minute exposure period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The relative mean viability of the test item treated tissues was 112.6% after a 15-Minute exposure period and is not considered to be irritant to skin accordign to GHS criteria

Executive summary:

In view of the reported results being below thresholds for classification as irritant, it is considered unlikely that the diluted material manufactured and supplied (30 - 40% in water) will be irritating to skin.

It is not considered necessary to perform in-vivo testing on this substance in its concentrated form.