N-(carbamoylmethyl)taurine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 September 2018 - 13 September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

29. Jul. 2016

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Version / remarks:

30. May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(carbamoylmethyl)taurine

EC Number:

230-908-4

EC Name:

N-(carbamoylmethyl)taurine

Cas Number:

7365-82-4

Molecular formula:

C4H10N2O4S

IUPAC Name:

N-(carbamoylmethyl)taurine

Test material form:

solid

Specific details on test material used for the study:

Batch no. GL865320171205
Appearance White crystalline powder
Composition 2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
Purity ≥99% Assay (Titration)
Homogeneity homogeneous
Expiry date 5. Dec. 2019
Storage Room Temperature (20 ± 5 °C)

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

As per the OECD Guidelines.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Tissue 1 ( 3 min exposure): 26.7 mg
Tissue 2 ( 3 min exposure): 25.4 mg
Tissue 1 ( 1 h exposure): 25.9 mg
Tissue 2 ( 1 h exposure): 26.6 mg

Duration of treatment / exposure:

3 minutes and 1 hour

Duration of post-treatment incubation (if applicable):

3 hours at 37 ± 1°C and 5.0 ± 0.5% CO2

Number of replicates:

Triplicate wells for two sets of tissues.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean of two tissues (3 min)

Value:

85.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean ot two tissues (1 h)

Value:

100.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.6 (3 minutes) and 1.5 (1 hour). The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The mean value of relative tissue viability was 9.3%. Values for negative control and for positive control were within the range of historical data of the test facility. Therefore the experiment is considered valid.

Any other information on results incl. tables

Mean Absorbance Values of the 3 Minutes Experiment

Designation	Negative Control	Substance	Positive Control
Mean – blank (tissue 1)	1.668	1.478	0.559
Mean – blank (tissue 2)	1.630	1.343	0.492
Mean of the two tissues	1.649	1.411	0.526
Relative standard deviation	1.6%	6.8%	9.0%

 

Mean Absorbance Values of the 1 h Experiment

Designation	Negative Control	Substance	Positive Control
Mean – blank(tissue 1)	1.576	1.563	0.134
Mean – blank (tissue 2)	1.500	1.536	0.151
Mean of the two tissues	1.538	1.550	0.143
Relative standard deviation	3.5%	1.2%	8.6%

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is considered to be non-corrosive to skin based on a reliable in vitro skin corrosion study conducted according to OECD TG 431.

Executive summary:

In an in vitro skin corrosion study conducted according to OECD TG 431, human skin tissue (epidermis keratinocytes) was exposed to undiluted substance for 3-minutes and 1-hour. The mean value of relative tissue viability of the substance was 85.5% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1-hour treatment, the mean value of relative tissue viability of the substance was 100.8%, which is above the threshold for corrosivity (15%). Therefore, the substance is considered as non-corrosive to skin.

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