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Administrative data

Description of key information

Skin irritation:
OECD 404: not irritating according to CLP (Bioassay, 2012)
Eye irritation:
in vitro HET-CAM Test: Test substance causes serious eye damage (BASF SE, 2009)

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The potential of Kerocom FM 38 to cause acute dermal irritation or corrosion was assessed in a study according to OECD guidelone 404 and GLP (Bioassay, 2012) by a single topical application of an amount of 0.5 mL of the test item for 4 hours to the intact skin of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the

application area was washed off.

The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals until day 14.

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

· Very slight to well-defined erythema (grade 1 to 2)

· Very slight edema (grade 1)

· Additionally erythema and edema beyond the application were observed

The cutaneous reactions were reversible in all animals within 14 days after removal of the patch at the latest.

Mean scores over 24, 48 and 72 hours for each animal were 1.3, 2.0 and 2.0 for erythema and 0.7, 0.0 and 0.7 for edema.

Considering the described cutaneous reactions as well as the average score for irritation, Kerocom FM 38 shows a slight skin irritating potential under the test conditions chosen.

The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 μL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™, OECD 431 guideline). Two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure 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 suitable 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 EpiDerm skin corrosivity test showed the following results:

The test substance is able to directly reduce MTT. Therefore an additional MTT reduction control was introduced. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing.

Viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 105%.

Viability of the test-substance treated tissues determined after an exposure period of 1 hour was 91%.

Based on the observed results and applying the evaluation criteria cited in chapter 3.8 it was concluded, that the test substance does not show a corrosive potential in the EpiDerm™ skin corrosivity test under the test conditions chosen.

Eye irritation:

The potential of the test substance to cause serious damage to the eyes/mucous membranes was assessed by a single topical application of 0.3 mL of the undiluted test substance and 0.3 mL of a 10% test-substance solution in olive oil to the chorionallantoic membrane (CAM) of fertilized and incubated hen eggs.

Three eggs per test-substance concentration were observed until unambiguous irritation reactions were detected. The occurrence of vascular injury or intravascular coagulation in response to the test substance was recorded.

The undiluted test substance caused moderate intravascular coagulation and slight haemorrhagia in all eggs after 51 – 64 seconds.

The 10% test-substance solution in olive oil caused moderate intravascular coagulation and slight haemorrhagia in all eggs after 30 – 41 seconds.

Based on the results of this study it is concluded, that the test substance causes serious eye damage in the HET-CAM Test under

the test conditions chosen.


Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, a classification as irritating to the skin (R38) accoring to 67/548/EWG is warranted. The substance is however not irritating to the skin according to CLP (1272/2008/EG). In addition, the test substance poses the risk of serious damage to the eye (R41/ Cat. 1) according to 67/548/EWG and 1272/2008/EG (CLP).