Registration Dossier

Administrative data

Description of key information

Skin irritation

The skin irritation test is less sensitive than the eye irritation. Since the eye irritation result is negative, the skin irritation is likely to be negative as well. Moreover, based on weight of evidence for taurine, it can be reliably predicted that there is no potential for skin irritation.

Eye irritation

The in vitro eye irritation result (OECD 492) is negative.

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:
weight of evidence
Study period:
in vitro skin irritation
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
A review of taurine and its salts, including those of secondary amines
Work is to support use of these amino acid derivatives in cosmetics
Limited data on the animal work performed historically, but conclusion is that these are not potential for skin irritation
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
Note that the review covers taurine and derivates; testing appears to have been performed on salts, but the review concludes that these can all be groups for evaluation purposes.
Test system:
human skin model
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Amount / concentration applied:
10 mg in 5 µL sterile water to wet the test substance; >90% pure
Irritation / corrosion parameter:
% tissue viability
Value:
100
Negative controls valid:
not specified
Positive controls valid:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
A review of taurine and its salts, including those of secondary amines
Work is to support use of these amino acid derivatives in cosmetics
Limited data on the animal work performed historically, but conclusion is that these are not potential for skin irritation
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
human
Details on test animals or tissues and environmental conditions:
The EpiOcularTM tissue model (OCL-200-MatTek Corporation) is composed of stratified human keratinocytes in a three-dimensional structure, reflecting the morphology and function of the human corneal epithelium found in vivo.
Irritation parameter:
in vitro irritation score
Run / experiment:
Percentage of viability
Value:
ca. 81
Negative controls valid:
yes
Positive controls valid:
yes
Interpretation of results:
GHS criteria not met
Conclusions:
The viability of the test result is 81% and it is higher then the classification criteria, viability < 60%. Therefore, the test substance is not classified for eye irritation.
Executive summary:

In this study, the eye irritation potential of 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid (CAS 10191-18-1, EC 233-465-5) was assessedin vitroaccording to OECD Test Guideline 492 (Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage).


After 6h ± 15 mins’ exposure on the surface of EpiOcularTMreconstructed ocular epithelium and 18h ± 15 mins post-incubation time, the viability of the tissues was assessed and compared to a negative control. The percentage viability obtained was 81.068 % and therefore:

2 -[bis(2-hydroxyethyl)amino]ethanesulphonic acid (CAS 10191-18-1, EC 233-465-5) was classified as non-Irritant to the human eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification