Taurine

Endpoint summary

Description of key information

For this endpoint, experimental GLP compliant assays were performed according to OECD TG 439, 437, and 492.

The data are documented in the robust summary and the result of this assay is shown below.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-06-10 - 2016-07-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Designation: Art. 808616
Synonym: Taurine
CAS-No.: 107-35-7
Batch: S6261016
Purity: 99.9% (acidimetric)
Appearance: White, crystalline powder
Minimum shelf life: September 30, 2020
Storage: Tightly closed, dry +15 to +25°C

The test item was applied neat to the tissues.

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from a single donor

Justification for test system used:

standard model

Vehicle:

unchanged (no vehicle)

Remarks:

No vehicle used; Test item was applied neat to the tissues

Details on test system:

CELL CULTURE
- Supplier: Episkin/SkinEthic Laboratories, Lyon, France
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 16-RHE-066
- Expiration date: 2016-07-04

Control samples:

yes, concurrent negative control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 16 mg per tissue

NEGATIVE CONTROL
- Amount applied: 16 µL per tissue (Dulbecco`s Phosphate-Buffered Saline)

POSITIVE CONTROL
- Amount applied: 16 µL per tissue
- Concentration: 5% aqueous solution of sodium dodecyl sulfate in deionised water

Duration of treatment / exposure:

42 min (± 1 minute)

Duration of post-treatment incubation (if applicable):

42 hours (± 1 hour)

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Experiment 1 / Run 1

Value:

99.48

Vehicle controls validity:

not applicable

Remarks:

The test item was applied neat to the tissues.

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 2.164, 1.953 and 1.934 and, thus, in the range of ≥0.8 and ≤3.0.

Acceptability of the Positive and Negative Control Data:
After treatment with the negative control (DPBS-buffer) the mean OD was 2.017 (standard deviation: 6.32%) and, thus, higher than the historically established threshold of 1.416.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.12% (standard deviation: 8.14%) and, thus, lower than the historically established threshold of 3.23%.

Variability of the Data:
The standard deviation between the three tissues replicates treated with the test item was 3.11% and, thus, ≤18%. The standard deviations between the three tissue replicates of the negative control and the positive control were 6.32% and 8.14%, respectively, and, thus, ≤18%.

The study met all acceptance criteria.

Group	Time / [min]	Mean OD	Mean Relative viability / [%]
Negative Control	42	2.017	100
Positive Control	42	0.023	1.12
Test Material	42	1.939	99.48

Interpretation of results:

not irritating

Remarks:

UN GHS: No Category (according to OECD TG 439)

Conclusions:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.

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:

June 10, 2016 - August 29, 2016

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 Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Designation: Art. 808616
Synonym: Taurine
CAS-No.: 107-35-7
Batch: S6261016
Purity: 99.9% (acidimetric)
Appearance: White, crystalline powder
Minimum shelf life: September 30, 2020
Storage: Tightly closed, dry at +15 to +25°C

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

750 µL (i.e. 150mg/750µL) of test item, negative or positive control

Duration of treatment / exposure:

240 minutes

Number of animals or in vitro replicates:

in vitro: triplicate design

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

4

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

		Opacity	Permeability	IVIS
				per cornea	per group (mean value)	SD
Negative control	0.9% NaCl Solution	1.487	0.002	1.477	1.2	1.1
		-0.131	-0.001	-0.106
		2.067	0.000	2.102
Positive control	20% Imidazole solution	65.778	1.679	97.811	102.6	10.1
		61.921	1.494	95.834
		77.183	2.144	114.226
Test item	Art. 808616	3.671	0.004	3.725	4.0	1.1
		2.967	0.008	3.081
		5.110	0.005	5.183

Interpretation of results:

other: could not be determined

Conclusions:

Under the conditions of the present study, the eye hazard potential of the test item Art. 808616 (Taurine) cannot be predicted.

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. Under the conditions of the present study, the eye hazard potential of the test item Art. 808616 (Taurine) cannot be predicted.

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No classification is warranted.