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EC number: 258-605-2 | CAS number: 53523-90-3
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Jan 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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)
- Principles of method if other than guideline:
- Test system HCE: Assessment of the ocular irritation potential by determination of the cytotoxic effect of a test item on the human corneal epithelium model (exposure 60 min./rt followed by 16 hours incubation at 37 °C, subsequently MTT).
The HCE model is recognized in the scientific community as a highly valuable model for the identification of substances that do not require classification for severe eye damage/eye irritancy (e.g. Cotovio et. al., Tox. in Vitro, 24, 2010, 523-537), and is routinely used by cosmetic and pharmaceutical companies. It has been prevalidated (van Goethem et. al., Tox in Vitro 20, 2006, 1-17; Alépée et al., Tox in Vitro 27, 2013, 1476-1488) and has entered formal ECVAM validation in 2010. Although a high reproducibility was attested within the validation process, a further need for optimization was identified. A recently conducted multi-laboratory validation study again demonstrated that the assay in general is a promising tool that may be used in combination with others for a solid eye irritation risk assessment (Alépée et al., Toxicol in Vitro 31, 2016, 43–53). - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]
- EC Number:
- 258-605-2
- EC Name:
- Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]
- Cas Number:
- 53523-90-3
- Molecular formula:
- C30H20Li4N4O12S2
- IUPAC Name:
- tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]
- Reference substance name:
- Unknown impurities, none of which are present at ≥1%
- Molecular formula:
- Unknown impurities, none of which are present at ≥1%
- IUPAC Name:
- Unknown impurities, none of which are present at ≥1%
- Test material form:
- liquid
Constituent 1
impurity 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- The experiment was carried out on a Human Corneal Epithelial (HCE) Model, which is standardized and commercially available (SkinEthic, France). Inserts were of 0.5 cm² size. When cultivated at the air-liquid interface in a chemically defined medium, the immortalized human cornea epithelial cells reconstruct a corneal epithelial tissue (mucosa), without a stratum corneum, ultra-structurally (tissue morphology and thickness) similar to the corneal mucosa of the human eye.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg per insert
- Duration of treatment / exposure:
- 60 min. (room temperature)
- Duration of post- treatment incubation (in vitro):
- 16 hours (37°C, 5% CO2, maximum humidity)
- Number of animals or in vitro replicates:
- 3 inserts
- Details on study design:
- DETAILS OF THE TEST PROCEDURE USED
The irritation potential of the test item is assessed by determination of its cytotoxic effect on a reconstructed human ocular epithelium. The test principle is based on the MTT assay reflecting the cell viability after exposure of the cornea equivalent to topically applied test item.
The test substance was applied unchanged, i.e. 30 mg per insert (plus 30 µL PBS to moisten and ensure good contact with the tissue surface) for 60 min at room temperature. After the exposure period the inserts were washed carefully with PBS. MTT reduction was performed after a post-exposure incubation of 16 hours in the incubator (37 +/- 2 °C, 5 % CO2, maximum humidity). Cell viability was measured by the amount of MTT reduction, i.e. an OD value following exposure to the negative or positive control substances or the test item.
NUMBER OF TISSUE REPLICATES
Tests were performed in triplets for test substance, positive and negative control.
DECISION CRITERIA:
A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is ≤ 50 %.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: cell viability (%)
- Run / experiment:
- decision criteria: ocular irritant if cell viability = 50 %; mean
- Value:
- 103.54
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Summary of results:
Sample No. | Test item | %Viability (mean) |
1 -3 | Negative control (PBS) |
100.00 |
4 -6 |
Positive control (SDS 0.3%) |
27.66 |
13 -15 |
test substance |
103.54 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No indication for an eye irritant potential was seen in an in vitro test (human coreneal epithelial model; cp. Cotovio et al., Toxicol. in Vitro 24, 523-537, 2010).
- Executive summary:
An in vitro study for assessing ocular irritation was conducted in a human corneal epithelial cell model (HCE; Episkin, France). This model is recognized in the scientific community as a highly valuable model for the identification of substances that do not require classification for serious eye damage/eye irritancy (e.g. Cotovio et al., Toxicol. in Vitro 24, 523 -537, 2010), and is routinely used by cosmetic and pharmaceutical companies.
In this study 30 mg of this test item was applied topically to the reconstructed HCE tissue (plus 30 µL PBS to moisten and ensure good contact with the skin). After an exposure period of 60 minutes (room temperature), followed by a 16 hours post-treatment incubation period (37 °C, 5 % CO2, maximum humidity), the cell viability was 103.5 %, as measured by a MTT conversion assay. Based on this assay no potential for eye irritation was concluded.
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