1-Heptanol, 2-propyl-, 1,1'-carbonate

Endpoint summary

Description of key information

The potential for skin irritation of test item was tested in a reconstructed three dimensional human epidermis model (EpiDerm).The test item does not show a skin irritation potential in the EpiDerm™ skin irritation test. The potential for eye irritation was tested in three studies. In the key study, the test item was tested in three White New Zealand rabbits according to OECD guideline No. 405. In the first supporting study, the test item was tested to a reconstructed three dimensional human cornea model (EpiOcular™). In the second supporting study, the Bovine Corneal Opacity and Permeability test (BCOP test), the test item was tested by a single topical application of 750 μL of the undiluted test substance to the epithelial surface of isolated bovine corneas. The test item does not cause eye irritation and eye damage in all three studies. 

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)

Additional information

Skin irritation:

The potential of test item to cause dermal irritation was assessed by a single topical application of 30 μL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™) according to OECD guideline no. 439. Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was about 101%. The test item does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions choosen.

Eye irritation:

In the key study, the test item was tested by a single ocular application of 0.1 mL to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals) according to OECD guideline no. 405. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 and 96 hours after application.

The ocular reactions were reversible in all animals within 48 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity; 0.0, 0.0 and 0.0 for iris lesions; 0.3, 0.0 and 0.0 for redness of the conjunctiva and 0.3, 0.0 and 0.0 for chemosis. Considering the described ocular reactions as well as the average score for irritation, the test item does not show an eye irritating potential.

In the first supporting study, the test item was tested by a single topical application of 50 μL of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissue samples were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results: The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was about 104%. The test item does not show an eye irritation potential in the EpiOcular™ eye irritation test.

In the second supporting study, the test item was tested in the Bovine Corneal Opacity and Permeability test (BCOP test) according to OECD guideline No. 437. The potential of the test item to cause serious damage to the eyes was assessed by a single topical application of 750 μL of the undiluted test substance to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance for 10 minutes followed by a 2-hours post-incubation period. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas. Based on the results, the test item does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. The test method does not yet allow for the evaluation of eye irritation.

Justification for selection of skin irritation / corrosion endpoint:
Only one key study is available.

Justification for selection of eye irritation endpoint:
standard test system (OECD guideline was followed)