Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane

Endpoint summary

Description of key information

The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles. It is concluded that Glycolierral is irritating in the in vitro skin irritation test. This is supported by a skin sensitisation study in which slight irritation was observed when guinea pigs were repeatedly exposed epicutaneously (21 days) to 100% of the test substance.
The substance Glycolierral is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test performed according to OECD 437 guideline and GLP principles. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

In an in vitro skin irritation test using a human skin model ( EPISKIN Small Model), the influence of the test substance on the viability of human skin was tested.

The test substance (25 μl) was applied directly to 0.38 cm²cultured skin. After 15 minutes, the substance was removed and cells were cultured for 42 hours. Glycolierral was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that Glycolierral did not interact with MTT. The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 8% whereas the test substance showed cell viability of 27%. Since the mean relative tissue viability after exposure to the test substance was below 50%, it can be concluded that the test substance is irritating in the in vitro skin irritation test. Based on these data it can be concluded that the substance is not corrosive and no further testing is required. This is supported by a skin sensitisation study in which slight irritation was observed when guinea pigs were repeatedly exposed epicutaneously (21 days) to 100% of the test substance.

Eye irritation:

The substance Glycolierral was screened for the eye irritation potential using the Bovine Corneal Opacity and Permeability test performed according to OECD 437 guideline and GLP principles.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 117 and was within the historical positive control data range. Negative and positive controls were valid and it was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Glycolierral did not induce ocular irritation through both endpoints, opacity and permeability, resulting in a meanin vitroirritancy score of 1.0 after 10 minutes of treatment. Based on the results, it is concluded that Glycolierral is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test. Since Glycolierral induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage and no additional in vivo testing is required at this score.

Justification for selection of skin irritation / corrosion endpoint:
An in vitro skin irritation on the substance is available.

Justification for selection of eye irritation endpoint:
An in vitro eye irritation on the substance is available.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the results, Glycolierral should be classified as Skin irritant category 3 and labelled with H316: Causes skin irritation according to Regulation (EC) No 1272/2008. Glycolierral does not have to be classified for eye irritation.