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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:
17-07-2013 to 18-07-2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: not formally validated study method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Principles of method if other than guideline:
The SkinEthic reconstructed human corneal epithelium assay is used
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: gel
Details on test material:
- Substance type: UVCB
- Physical state: paste
- Purity: 100% (UVCB)
- Storage condition of test material: room temperature in dark

Test system

Details on study design:
The SkinEthic reconstructed human corneal epithelium assay uses corneal epithelial tissue to assess penetration and concomittant cytotoxicity of the test substance.

In a pre-test direct interaction of the test substance with the detection chemical MTT is assessed.
In the main study triplicate SkinEthic tissues were treated with 30 uL of the test substance during 10 minutes. In addition a negative control (Na2HPO4 0.142 g/L; glucose 1.802 g/L; HEPES 7,149 g/L; KCl 0.224 g/L; NaCl 7.597 g/L) and a positive control (2% SDS) were included. After treatment tissues (3 per treatment) were rinsed and treated with MTT. Optical density of extracted MTT solutions was measured at 562 nm. Viability was expressed as percentage MTT conversion versus negative control.
Tissue viability ≥ 60% means non-irritant
Tissue viability < 60% means irritant

Results and discussion

In vitro

Results
Irritation parameter:
other: % tissue viability
Value:
89.4
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
6.7% rel viability

In vivo

Other effects:
The test substance did not interfere with the reduction of MTT to blue formazan salt.

Any other information on results incl. tables

 

Mean OD562

Relative mean viability

Negative control:

0.940

100%

Test substance:

0.840

89.4%

SDS:

0.063

6.7%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is non-irritant in the SkinEthic reconstructed human corneal epithelium assay.
Criteria used for interpretation of results: other: < 60% viability is indicative for positive result
Executive summary:

In this assay triplicate SkinEthic tissues were treated with 30 uL of the test substance during 10 minutes. After treatment tissues were rinsed and treated with MTT. Optical density of extracted MTT solutions was measured at 562 nm. Viability was expressed as percentage MTT conversion versus negative control. The viability was 89.4%, which is indicative for non-irritant substances.

As the assay is not formally validated, the results need to be regarded as preliminary.