Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23/05/2017 until 24/05/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
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)
Version / remarks:
2013
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Details on test animals or tissues and environmental conditions:
EpiOcular tissue is a non-keratinized epithelium prepared from normal human keratinocytes (MATEK, Bratislava, Slovakia)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
protocol for liquid test items: 50 µL
Duration of treatment / exposure:
30 minutes + 12 minutes post-treatment immersion + 120 minutes post treatment incubation
Duration of post- treatment incubation (in vitro):
120 minutes post treatment incubation
Number of animals or in vitro replicates:
2

Results and discussion

In vitro

Results
Irritation parameter:
other: relative viability (%)
Run / experiment:
Microcare Amide RIAM
Value:
18.8
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

The test chemical is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) as the mean percent tissue viability after exposure and post-exposure incubation is less than 60%. Further testing with other test methods is required because the EpiOcular test shows a certain number of false-positive results and cannot resolve between UN GHS Catergories 1 and 2.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The viability of the reconstructed Human Epithelial Corneal Model (EpiOcular) treated with Microcare Amide RIAM was below 60%. The Microcare Amide RIAM was classified as potentially irritant for eyes according the the OECD 492 guideline.