2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid

Endpoint summary

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

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

not specified

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 validity:

not specified

Positive controls validity:

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

Qualifier:

according to guideline

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. QA statement)

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 validity:

valid

Positive controls validity:

valid

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