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Administrative data

Description of key information

skin: not irritating (OECD 431/439, GLP; BASF, 2013)
eye: not irritating (OECD 405, GLP, Bioassay, 2013)

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:

EpiDerm:

The potential of LUGALVAN BPC dry to cause dermal corrosion/irritation was assessed by a single topical application of 25 µL bulk volume (about 13 mg) of the undiluted test substance to a reconstructed three dimensional human epidermis model (EpiDerm™) according to OECD 431/439 guidelines and GLP (BASF, 2013).

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 a42-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 corrosion/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 89%, and it was 100% 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 hourwith about 42 hours post-incubationwas 86%.

Based on the observed results and applying the evaluation criteria cited in chapter3.8it was concluded, that LUGALVAN BPC dry does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.

Eye irritation:

The potential of LUGALVAN BPC dry to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 31mg) of the test item to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). The study was conducted according to OECD 405 guideline and GLP (Bioassay, 2013). About 24 hours after application the eye was rinsed with tap water.

The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application.

The following test item-related clinical observations were recorded during the course of the study:

- slight to obvious conjunctival redness (grade 1-2)

- slight conjunctival chemosis (grade 1)

- slight discharge (grade 1)

- Additional findings like injected scleral vessels in a circumscribed area were noted in the animals from hour 1 after application until hour 48 at the latest.

The ocular reactions were reversible in all animals within 72 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, 0.7, 0.7 and 0.7 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, LUGALVAN BPC dry does not show an eye irritating potential under the test conditions chosen.

Justification for classification or non-classification

Based on the available data, the test substance is not classified with regard to eye irritation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.