Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-05-17 to 2016-05-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guidline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD Guideline for the Testing of Chemicals No. 492: (Reconstructed human Cornea-like Epithelium (RhCE) test method)
Qualifier:
according to
Guideline:
other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test - Summary
Qualifier:
according to
Guideline:
other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) For the prediction of acute ocular irritation of chemicals
GLP compliance:
yes (incl. certificate)
Remarks:
(Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Sodium oleylamphopolycarboxyglycinate
Common Name: AMPHOLAK XO7/C
Batch No.: 1297986
CAS No.: Active ingredient: CAS RN 97659-53-5
Aggregate State at RT: liquid
Active Components: 29.8% Sodium oleylamphopolycarboxyglycinate
59.8% Water
10.4% NaCl
Purity: 40% (Qualitatively estimated)
Stability: stable
Storage Conditions: room temperature
Expiry Date: 02 August 2017

Test system

Amount / concentration applied:
50 µL (undiluted)
Duration of treatment / exposure:
incubation: 30 min.
Observation period (in vivo):
post soak: 12 +/- 2 min.
post treatment: 120 min.
Details on study design:
The test was performed on EpiOcular, a reconstituted three-dimensional human corneal epithelium model. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 30 min exposure period and 120 min post-treatment period and compared to those of the concurrent negative controls.

Results and discussion

In vitro

Results
Irritation parameter:
other: Mean Relative Tissue Viability [%] from two tissues
Run / experiment:
In-vitro Eye Irritation: Ocular Irritation Assay using the EpiOcular Human Tissue Model
Value:
10.7
Negative controls validity:
valid
Remarks:
Aqua dest.
Positive controls validity:
valid
Remarks:
Methyl acetate
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

The mixture of 50 µL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture turned to dark red, but not blue/purple.

Although the absorption spectra of the mixture showed a peak at 555 nm with an OD of 2.5296, the NSMTT was not determined since the viability of the test item treated tissues (TM) was below 60%.

The mixture of 50 µL test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent.Therefore, NSC equaled 0%.

Applicant's summary and conclusion

Conclusions:
In this study under the given conditions the test item showed irritant effects. The test item is classified as “irritant“ in accordance with UN GHS “Category 1” or “Category 2”.
Executive summary:

Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with Aqua dest.

The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (10.7%).

The controls confirmed the validity of the study. The mean absolute OD570of the two negative control tissues was> 0.8 and < 2.5 (2.082). The mean relative tissue viability (% negative control) of the positive control was < 50% (32.5%). The maximum inter tissue difference of replicate tissues of all dose groups was < 20% (0.1 – 9.4%).

This study is classified as acceptable. This study satisfies the requirement for OECD Guideline for the Testing of Chemicals No. 492: (Reconstructed human Cornea-like Epithelium (RhCE) test method).