[2R-(2α,3Z,5α)]-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, compound with tert-butylamine (1:1)

Repeated dose toxicity: dermal

Administrative data

Endpoint:

repeated dose toxicity: dermal

Adequacy of study:

other information

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

In the interest of animal welfare, we propose a data waiver for the repeat dose toxicity study via the dermal route., due to the following reasons: No effects have been seen via the oral route of exposure. We had orriginally planned on conducting an acute inhalation study, as the properties of the test material (a high vapour pressure) were expected to cause more concern via the inhalation route of exposure as opposed to the dermal route of exposure. Testing was attempted via the inhation route of exposure but this could not be done due to the nature of the substance. It proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals. Various animal studies have been conducted on the read across material, these include studies of varying different length and studies conducted on a range of species. Although alot of this data is quite old, it is all fairly reliable and in most places can be considered to have a reliability of 2 according to the klimisch scale. Studies include a 6 month dog study, a 90 day mouse study, two teratology studies (one study on the rabbit and one study on the rat) and a fertility study. None of these studies were classified towards human health and therefore in the interests of animal welfare we propose a data waiver for this endpoint. Furthermore, as the test item tBA clavulanate is used as an intermediate in the formation of Potassium clavulanate, the substance tBA clavulanate is unlikely to be released into the environment or released to the public. Therefore if any testing was to be conducted we would propose that it would be more beneficial to have this study conducted on the surrogate material, potassium clavulanate as opposed to tba clavulanate as potassium clavulanate is much more likely to be exposed to the public and the environment.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified