Registration Dossier

Administrative data

Description of key information

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

Skin Irritation:

The potential of GSID 3056-1 to cause dermal corrosion/irritation was assessed by a single topical application of 25 μL bulk volume (about 13 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™) (OECD 431/439, BASF SE 61V0788/11A4842012, 2012). 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 testsubstance 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.

Regarding corrosion, the mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 97%, and it was 107% after an exposure period of 1 hour. Regarding irritation , the mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 99%. Based on the observed results, GSID 3056-1 does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.

Eye Irritation:

The potential of GSID 3056-1 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 cornea (OECD 437, BASF SE 63V0788/11A485, 2012). Three cornea 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 GSID 3056-1 does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. The test method according to the regulatory accepted protocol at the time of reporting does not allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.


Justification for selection of skin irritation / corrosion endpoint:
only test available

Justification for selection of eye irritation endpoint:
only test available

Justification for classification or non-classification

Based on the combined in vitro approach based on the OECD TG 431 and 439, there is no indication for the test item to be corrosive or irritant to the skin. Furthermore,the BCOP in vitro approach for the eye based on the OECD TG 437 gives no indication for the test item to cause serious eye damages. Thus, at the moment, no classification of the test item according to either the EU Directive 67/548/EEC or the CLP Regulation (EC) No. 1272/2008 is needed.