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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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. QA statement)
Remarks:
Laus GmbH

Test material

Constituent 1
Chemical structure
Reference substance name:
Trizinc dicitrate
EC Number:
208-901-2
EC Name:
Trizinc dicitrate
Cas Number:
546-46-3
Molecular formula:
C6H8O7.3/2Zn
IUPAC Name:
trizinc dicitrate
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%).