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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
Study period:
14 may to 3 october 2015
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Thyme, Thymus mastichina, ext.
EC Number:
284-294-8
EC Name:
Thyme, Thymus mastichina, ext.
Cas Number:
84837-14-9
Molecular formula:
Not relevant for UVCB
IUPAC Name:
Thyme, Thymus mastichina, ext.
Test material form:
liquid: volatile

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50µL
Duration of treatment / exposure:
30 minutes
Duration of post- treatment incubation (in vitro):
Tissues treated with liquid test items and with control substances tested concurrently to liquid test items are incubated for 30 ± 2 minutes at standard culture conditions
Number of animals or in vitro replicates:
two tissue replicates
Details on study design:
The test item Marjoram oil was applied, as supplied, at the dose of 50 µL, to 2 living DPBS pretreated RhCE (EpiOcular TM tissue model) during 30 minutes at 37°C, 5% CO2, 95% humidity (standard culture conditions). The exposure period was followed by extensive rinsing with DPBS at room temperature, a 12 minutes post-exposure immersion period at room temperature and a 2 hours post-exposure incubation at standard culture conditions. The tissue viability was measured by performing an MTT assay.
The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 492 adopted 09 October 2017.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: mean percent tissue viability (%)
Run / experiment:
sample 7 test item
Value:
44.43
Positive controls validity:
valid
Irritation parameter:
other: mean percent tissue viability (%)
Run / experiment:
sample 8 test item
Value:
49.29
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The mean percent tissue viability of the RhCE replicates treated with the test item Marjoram oil was 46.86% versus 1.32% in the positive control (Methyl acetate).
In accordance with the Regulation EC No.1272/2008, the test item Marjoram oil has to be identified as potentially requiring classification and labeling according to UN GHS Category 2 or Category 1.