Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): I850
- Substance type: White crystalline powder
- Composition of test material, percentage of components: 99.1%
- Lot/batch No.: 7604
- Storage condition of test material: Ambient

Test animals / tissue source

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.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Percentage of viability
Value:
ca. 81
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

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.