Magnesium bis(2-ethylbutanoate)

Endpoint summary

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

The available skin irritation study was an in vivo study on rabbits, performed according to GLP and OECD guidelines (rated K1). In this study, well-defined erythema only was observed in two animals on removal of the dressings. These reactions gradually ameliorated and had resolved by either Day 3 or 4. No dermal response to treatment was noted in the remaining animal. Based on these observations it could be concluded that the substance can be slightly irritating, however not sufficient for classification.

Related to eye irritation, two studies are available. The first study was performed according to GLP and OECD guidelines and was rated K1 (Parcell, 1996). In this study, rabbits were exposed, in vivo, to RSS-4 as dry substance. A single instillation of RSS-4,dry substance into the eye of the rabbit elicited well defined conjuctival irritation only. All reactions had resolved four or seven days after instillation. At the time of the test, ocular irritation characteristics of RSS-4 were assessed against the labelling criteria in accordance with Commission Directive 93/21EEC and it was concluded that labelling R36 "Irritating to eyes" is not required for RSS-4. The second study is less documented and therefore indicated as a supporting study (Birch, 1981). In this study, the substance was tested as 30% in an aqueous solution. Based on the results of this study, the substance would not be seen as an irritant since slight erythema was seen after 24h, but not at any of the later timepoints.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Skin irritation:

The information on skin irritation is straightforward and indicates that the substance should not be classified as skin irritant under EC1272/2008.

Eye irritation:

The information on eye irritation however is less straightforward. One test indicates that the substance can cause irritation (Parcell, 1996), although conjuctival irritation only. According to the other study (Birch, 1981) irritation effects are negligable. Both test results evaluated under the Dangerous Substances Directive indicate that the substance should not be classified as an eye irritant (or R36). Evaluating these results under CLP (EC1272/2008) however, results in a borderline or inconclusive case. The test results from the second test indicate that classification is not required (this test was performed with the product as it is marketed). The test results from the first study (dry substance) indicate that classification as Eye irritant Cat. 2 would be warranted, although a borderline case.