Registration Dossier

Administrative data

Description of key information

In vitro skin corrosivity test

BAL0001024 is non-corrosive to skin.

In vitro skin irritation test 

BAL0001024 is non-irritant to skin (No Category).

In vitro eye irritation study

BAL0001024, is a non-irritant: UN GHS Classification: No Category.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In Vitro Skin Corrosivity

An in vitro skin corrosivity test of the test item BAL0001024 was performed in a reconstructed human epidermis model.

Disks of EPISKINTM(SM) were treated with BAL0001024 and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with Phosphate Buffered Saline solution.

Following exposure to BAL0001024, the mean cell viability was 106.5% compared to the negative control, which is above the threshold of 35%, therefore the test item was considered as being non-corrosive.

In conclusion, in this in vitro EPISKIN™(SM) test model, the results indicate that BAL0001024 is non-corrosive to skin.

In Vitro Skin Irritation

An in vitro skin irritation test of BAL0001024 test item was performed in a reconstructed human epidermis model.

Disks of EPISKINTM (SM) (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure to the test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated at 37 °C for 42 hours in an incubator with 5% CO2 in a >95% humidified atmosphere.

Following exposure with BAL0001024, the mean cell viability was 89.5% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid.

In conclusion, in this in vitro EPISKINTM (SM) model test with BAL0001024 (Batch number: 012), the results indicate that the test item is non-irritant to skin (No Category).

In Vitro Eye Irritation

An in vitro eye irriation study was performed in isolated chicken’s eyes on the test item, BAL0001024.

The study was conducted in 2 stages; the first experiment (Experiment I) provided an initial assessment of the irritation potential of the test item which was confirmed in a second experiment (Experiment II).

 

Experiment I: No significant corneal swelling (mean ≤5%) was observed during the four-hour observation period on test item treated eyes. No cornea opacity change (severity 0.5 on one eye and no cornea opacity change on two eyes) was observed on test item treated eyes. No significant fluorescein retention change (severity 0.5 on one eye and no fluorescein retention change on two eyes) was noted on test item treated eyes.

Experiment II: No significant corneal swelling (mean ≤5%) was observed during the four-hour observation period on test item treated eyes. No significant cornea opacity change (severity 0.5 on two eyes and no cornea opacity change on one eye) was observed on test item treated eyes. No significant fluorescein retention change was noted on test item treated eyes. The test item was stuck on one corneal surface after the post-treatment rinse which was cleared 75 minutes after the post-treatment rinse.

Based on these in vitro eye irritation assay in isolated chicken eyes with BAL0001024, the test item was non-irritant: UN GHS Classification: No Category.

Justification for classification or non-classification

Skin Irritation / Corrosion

Based on the results of a corrosivity test the test item is non-corrosive.

In conclusion, the results indicate that BAL0001024 is non-irritant to skin (No Category).

Eye Irritation

Based on the in vitro eye irritation assay in isolated chicken eyes with BAL0001024, the test item was non-irritant: UN GHS Classification: No Category.