Reaction mass of 1,3-dimethyl-1,1,3,3-tetraphenyldisiloxane and 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane and 1,3,3,5,5,7-hexamethyl-1,1,7,7-tetraphenyltetrasiloxane

Endpoint summary

Key value for chemical safety assessment

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according 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)

GLP compliance:

yes (incl. QA statement)

Details on test animals or tissues and environmental conditions:

EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories,
Mylnské Nivy 73, 82105 Bratislava, Slovakia.
Designation of the kit: OCL-200-EIT
Day of delivery: 24. Jul. 2018
Batch no.: 27060

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50 μL of the liquid test item

Duration of treatment / exposure:

28 min

Duration of post- treatment incubation (in vitro):

115 min

Number of animals or in vitro replicates:

n=2

Irritation parameter:

other: relative tissue viability

Run / experiment:

1

Value:

91.4

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

other: relative tissue viability

Run / experiment:

2

Value:

95.2

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

All validity criteria were fulfilled.
Values for negative control and for positive control were within the range of historical data of the test facility.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, the test item is considered non- eye irritant in the EpiOcularTM Eye Irritation Test.

Executive summary:

One valid experiment was performed.

The test item was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 28 minutes.

50 μL of the liquid test was applied to two tissue replicates.

After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution.

Demineralised water was used as negative control and methyl acetate was used as positive control. The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD > 0.8 and < 2.5, OD was 1.9. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 34.7 % (< 50%).

Variation within tissue replicates of the controls and test item was acceptable (< 20%).

After treatment with the test item, the mean value of relative tissue viability was 93.3 %.

This value is well above the threshold for eye irritation potential (≤ 60%). Test items that induce values above the threshold are considered non-eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)