N-(carbamoylmethyl)taurine

Endpoint summary

Description of key information

In a reliable in vitro skin corrosion study human skin tissue (eipdermis keratinocytes) was exposed to the undiluted substance for 3 and 60 minutes. There was 85.5% and 100.8 % tissue viability following the 3 and 60 minute exposure, respectively. Resultantly, the substance is considered to be a non-corrosive to human skin.

In a reliable in vitro skin irritation study conducted on the substance the mean value of relative tissue viability was increased to 107.2% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the substance is considered to be a non-irritant to skin.

In a reliable in vitro eye irritation study employing bovine cornea were exposed to the undiluted substance for 4 hours. Opacity and permeability values were measured. The mean IVIS was -1.78 following the 4 hour exposure point. Resultantly, the substance is considered to be a non-irritant to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

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

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)

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)

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.

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

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.

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%

 

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.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 September 2018 - 14 September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

adopted 28. July 2015

Deviations:

yes

Remarks:

The pre-incubation time was 1 hour, instead of 18 ± 3 hours overnight. This can be seen as uncritical, because the pre-incubation time must be at least 1 hour (in consultation with the tissue supplier; MatTek In Vitro Life Science Laboratories).

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 06. Jul. 2012

Deviations:

yes

Remarks:

The pre-incubation time was 1 hour, instead of 18 ± 3 hours overnight. This can be seen as uncritical, because the pre-incubation time must be at least 1 hour (in consultation with the tissue supplier; MatTek In Vitro Life Science Laboratories).

GLP compliance:

yes (incl. QA statement)

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)

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)

Remarks:

Substance is a powder.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Tissue 1: 25.8 mg
Tissue 2: 24.2 mg
Tissue 3: 25.5 mg

Duration of treatment / exposure:

1 hour.

Duration of post-treatment incubation (if applicable):

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

Number of replicates:

Three

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean of three tissues

Value:

107.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

% Tissue Viability

Designation	N-(2-Acetamido)-2-aminoethanesulfonic acid; N-(Carbamoylmethyl)taurine (ACES)	Positive Control
% Tissue viability (tissue 1)	105.5%	4.1%
% Tissue viability (tissue 2)	106.4%	3.7%
% Tissue viability (tissue 3)	109.8%	3.3%
% Tissue viability (mean)	107.2%	3.7%
± SD of mean tissue viability (%)	2.3%	0.4%

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is considered to be a non-irritant to skin based on an in vitro study conducted according to OECD TG 439.

Executive summary:

In an in vitro skin irritation study conducted according to OECD TG 439 human skin tissue (epidermis keratinocytes) was exposed to the undiluted substance for 60-minutes. There was 107.2% tissue viability following the 60-minute exposure point. This value is above the threshold for skin irritation (50%). Resultantly, the substance is considered to be a non-irritant to human skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 September 2018 - 13 September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

Adopted
09. Oct. 2017

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for the Testing of Chemicals, Series on Testing and Assessment No. 160

Version / remarks:

“GUIDANCE DOCUMENT ON “THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) AND ISOLATED CHICKEN EYE (ICE) TEST METHODS: COLLECTION OF TISSUES FOR HISTOLOGICAL EVALUATION AND COLLECTION OF DATA ON NON-SEVERE IRRITANTS”, 25. Oct. 2011

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Version / remarks:

For Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted 14. Feb. 2017

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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: 05. Dec. 2019
Storage: Room temperature (20 ± 5 °C)

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Fresh bovine eyes were obtained, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Replicate 1: 551.4 mg
Replicate 2: 550.3 mg
Replicate 3: 550.3 mg

Duration of treatment / exposure:

4 hours at 32 ± 1 °C

Duration of post- treatment incubation (in vitro):

90 minutes at 32 ± 1 °C in a horizontal position

Number of animals or in vitro replicates:

Three

Irritation parameter:

in vitro irritation score

Run / experiment:

replica 1

Value:

0.72

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Irritation parameter:

in vitro irritation score

Run / experiment:

replica 2

Value:

-2.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Irritation parameter:

in vitro irritation score

Run / experiment:

replica 3

Value:

-2.03

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

The calculated IVIS for each replicate and the corresponding means are presented in the following table:

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control HBSS	1.91	2.18	30.52%
	1.69
	2.93
Substance	0.72	- 1.78	54.18%
	- 2.60
	- 2.03
Positive Control 20% imidazole solution	115.33	125.44	11.82%
	142.46
	118.53

Interpretation of results:

GHS criteria not met

Conclusions:

The substance showed no effects on the cornea of the in vitro bovine eye and the calculated mean IVIS was -1.78. Therefore the substance is considered to be a non-irritant to the eyes.

Executive summary:

In an in vitro opacity and permeability study employing bovine cornea, which were exposed to undiluted substance for 4 hours, opacity and permeability values were measured. There was a mean IVIS of -1.78 following the 4-hour exposure point. Resultantly, the substance is considered to be non-irritant to the eye and not expected to cause serious eye damage.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings of reliable in vitro skin irritation, skin corrosion and eye irritation studies conducted on the substance, classification of the substance is not justified.