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Toxicological information

Eye irritation

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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:
other: Study according to OECD guideline with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline for the Testing of Chemicals, Part 492, adopted 28. Jul. 2015 , “Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classifica-tion and Labelling for Eye Irritation or Serious Eye Damage"
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Laus GmbH

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
other: normal, human-derived keratinocytes
Details on test animals or tissues and environmental conditions:
Commercially available OCL-200-EIT / OCL-212-EIT EpiOcularTM tissue kit.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Neg. Controls: demin. H2O, pos. Controls: Methyl acetate
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50.4 mg
Duration of treatment / exposure:
6h
Observation period (in vivo):
post-treatment incubation: 18 h
Number of animals or in vitro replicates:
2 Tissues (according to guideline)
Details on study design:
Mean optical density was measured and viability was calculated according to guideline

Results and discussion

In vitro

Results
Irritation parameter:
other: %viability
Run / experiment:
Mean after 24 h
Value:
4.7
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid

In vivo

Irritant / corrosive response data:
After treatment with the test item, the relative absorbance values were reduced to 4.7 %.
This value is well below the threshold for eye irritation potential (≤ 60%).
Other effects:
All validity criteria were met. The criterion for optical density of the negative control was fulfilled: The OD value was 1.5 (> 0.8 and < 2.5).
The positive control induced a decrease in the relative absorbance as compared to the negative control to 32.1%.
Variation within the replicates was acceptable (<20 %).
For these reasons, the result of the test is considered as valid.

Applicant's summary and conclusion

Interpretation of results:
other: GHS category 1 or 2
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the test system, trizinc dicitrate is considered as eye irritant in the EpiOcularTM Eye Irritation Test (OECD 492).
Executive summary:

The test item trizinc dicitrate was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 h.

The solid test item was applied to each tissue. After treatment with the test item, the relative absorbance values were reduced to 4.7 %.

This value is well below the threshold for eye irritation potential (≤ 60%).