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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:
15-05-2012 to 17-05-2012
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:
2012
Report Date:
2012

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: extremely viscous liquid
Details on test material:
- Name of test material (as cited in study report): Fatty acids, tall oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid
- Substance type: UVCB
- Physical state: extremely viscous liquid
- 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 (2 per treatment) were rinsed and treated with MTT. Optical density of extracted MTT solutions was measured at 540 nm. Viability was expressed as percentage MTT conversion versus negative control.
Tissue viability ≥ 60% means non-irritant
Tissue viability < 60% means irritant
The third tissue per treatment was preserved for histopathology.

Results and discussion

In vitro

Results
Irritation parameter:
other: % tissue viability
Value:
79
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
25.5% tissue viability

In vivo

Other effects:
The test substance did not interfere with the reduction of MTT to blue formazan salt.
In the main test after rinsing the test substance was found to remain on the tissue surface due to the extreme viscosity.

Any other information on results incl. tables

 

Mean OD540

Relative mean viability

Negative control:

0.729

100%

Test substance:

0.626

79%

SDS:

0.202

25.5%

No histopathology was performed.

Applicant's summary and conclusion

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

In this assay triplicate SkinEthic tissues were treated with 30 uL of the test substance during 10 minutes. After treatment tissues (2 per treatment) were rinsed and treated with MTT. Optical density of extracted MTT solutions was measured at 540 nm. Viability was expressed as percentage MTT conversion versus negative control. The viability was 79%, which is indicative for non-irritant substances.

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