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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 May 2018- 30 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

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:
SOP LOO69 @EpiOcular Eye Irritation test Using XcellR8 form FOO68
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: crystalline
Details on test material:
Batch number 37160906202

Test animals / tissue source

Species:
other: Reconstructed Human Cornea-like Epithelium
Details on test animals or tissues and environmental conditions:
The EpiOcular tissue model (OCL-200-MatTek corporation) is composed of stratified human keratinocytes in a three dimensional structure, reflecting the morphology and funcion of the human corneal epithelium found in vivo.
On the day f receipt, pre-incubation of EpiOcular tissues overnight at 37C 5%CO2 >=95% relative ,humidity.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50mg
Duration of treatment / exposure:
6 hours+/-15 minutes
Duration of post- treatment incubation (in vitro):
25+/-2 minute post treatment immersion, and 18 hours +/-15 minutes post treatment incubation
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
other: Optical density
Run / experiment:
Optical density
Value:
ca. 2.219
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met