2-Propen-1-aminium, N,N,N-tripropyl-, salt with N-cyanocyanamide (1:1)

Endpoint summary

Description of key information

EpiDerm™ skin corrosion/irritation test: not irritating (BASF SE, 2011)
Bovine Corneal Opacity and Permeability Test (BCOP Test): no serious eye damage (BASF SE, 2011)
EpiOcular eye irritation test: irritating (BASF SE, 2011)

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:

adverse effect observed (irritating)

Additional information

Skin irritation/corrosion:

The key study was performed according to OECD guidelines 431 & 439 in complinace with GLP (BASF SE, 2011). The potential of the test item to cause dermal corrosion/irritation was assessed by a single topical application of 25μL bulk volume (about 13 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm). For the corrosion test two EpiDerm tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm tissue samples, which 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 the values indicates the relative tissue viability.

The EpiDerm skin corrosivity/irritation test showed the following results:

The test substance is not able to reduce MTT directly.

Corrosion test: The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 97%, and it was 98% after an exposure period of 1 hour.

Irritation test: The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 95%.

Conclusion: The test item did not show a skin irritation potential in the EpiDerm skin corrosion/irritation test under the test conditions chosen.

 

Eye irritation:

In a study that was performed according to OECD guideline 439 in compliance with GLP, the potential of the test item to cause serious damage to the eyes was assessed by a single topical application of 750 μL of a 20% test-substance preparation to the epithelial surface of isolated bovine corneas (BASF SE, 2011). Three corneas were treated with the test-substance preparation for an exposure period of 4 hours. 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 observed results and applying the evaluation criteria it was concluded, that the test item did not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.

 

In another study, the potential of the test item to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 19 mg) of the test substance to a reconstructed three dimensional human cornea model (EpiOcular). The study was performed in compliance with GLP (BASF SE, 2011). Two EpiOcular tissue samples were incubated with the test substance for 90 minutes followed by a 18-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 44%.

Conclusion: Based on the observed results and applying the evaluation criteria it was concluded, that the test item showed an eye irritation potential in the EpiOcular eye irritation test under the test conditions chosen.

Effects on eye irritation: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available experimental test data for skin irritation/corrosion and eye irritation are reliable and suitable for the purpose of classification under Directive 67/548/EEC. As a result the substance is classified as irritating to the eye (Xi, R36).

No classification is warranted concerning skin irritation/corrosion (data conclusive but not sufficient for classification).

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data for skin irritation/corrosion and eye irritation are reliable and suitable for the purpose of classification under Regulation (EC) No. 1272/2008. As a result the substance is classified as irritating to the eye (Cat. 2, H319, Causes serious eye irritation).

No classification is warranted concerning skin irritation/corrosion (data conclusive but not sufficient for classification).