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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

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

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
Chemical structure
Reference substance name:
[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate
Cas Number:
914918-26-6
Molecular formula:
C46H40O16
IUPAC Name:
[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate

Test animals / tissue source

Species:
human
Details on test animals or tissues and environmental conditions:
The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinocytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm2) are cultured on especially prepared cell culture inserts and are commercially available as kits (EpiOculaTM 200). Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Positive (Methyl acetate), and negative controls (deionized water were applied to two tissues each.
Amount / concentration applied:
TEST MATERIAL- Amount applied: 50 µL
Duration of treatment / exposure:
6 hours, after removal of test substance another 18 hours postincubation period
Duration of post- treatment incubation (in vitro):
Observations were recorded after removal of test substance.
Number of animals or in vitro replicates:
Two tissues were treated with each the test substance, the PC and the NC.
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing: To remove the test substance, the tissues were washed with sterile PBS. For this purpose the tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immediately immersed into 12-well plates, pre-filled with 5 mL/well prewarmed medium (post-soak immersion) in order to remove residual test substance. After 25 minutes of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium.TOOL USED TO ASSESS SCORE: The optical density at a wavelength of 570 nm (OD570) of the extracts containing formazan was determined spectrophotometrically.

Results and discussion

In vitro

Results
Irritation parameter:
other: viability %
Run / experiment:
mean
Value:
100
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The EpiOcularTM eye irritation test showed the following results:The test substance is not able to reduce MTT directly.The mean viability of the test-substance treated tissues was 100.1 %.Generally, the test substance is considered as irritant if the mean tissue viability is ≤ 60 % of the negative control and as non irritant if the viability lies above 60 % of the negative control. Therefore, the test substance is considered to be non-irritating to eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU