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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:
2016-11-21 to 2017-03-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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)
Version / remarks:
28 July 2015
Deviations:
no
Qualifier:
according to
Guideline:
other: MaTTek Corporation: EpiOcular Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals
Version / remarks:
29 Hune 2015
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid
Details on test material:
Minimum purity 95% w/w
Specific details on test material used for the study:
Name: Art. 132720 (RonaCare Pristine Bright)
Synonym: Avodiol
CAS-No.: 955359-35-0
Batch: EH16000620
Purity: 95 % (w/w) (HPLC)
Appearance: light cream, free flowing granules
Released until: 2018-06-30


PREPARATION OF THE TEST MATERIAL
The test item Art. 132720 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation.

Test animals / tissue source

Details on test animals or tissues and environmental conditions:
CELL CULTURE
- Supplier: MatTek Corporation (82105 Bratislava, Slovakia)
- Source: human epidermal keratinocytes cultured to form a stratified squamous epithelium
- Format: 24 well plate
- Batch: 23757


TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: 37°C
- Temperature of post-treatment incubation: 37°C

REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST ITEM: 50 mg
NEGATIVE CONTROL: 50 µL (deionised water)
POSITIVE CONTROL: 50 µL (methyl acetate)
Duration of treatment / exposure:
6 h
Number of animals or in vitro replicates:
duplicate
Details on study design:
According to guideline

Results and discussion

In vitro

Results
Irritation parameter:
other: cell viability
Run / experiment:
mean value
Value:
3.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

 Group Time / [h]  Mean Absorbance  Mean Relative viability / [%]
 Negative Control 6 1.355 100 
 Positive Control 6

0.247

18.2

 Test Item

6

0.044

3.3

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses an eye irritating potential.