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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable data.

Data source

Reference Type:
study report

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
Method: other: Test performed according to protocol MS83/8 and amendments.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
14C-labelled bronopol, batch No: 2C/DM, the specific activity 1.4 µCi/mg, radiochemical purity was ca. 97%.


Type of population:
Route of exposure:
Reason of exposure:
Details on exposure:
Soltan cream
Soltan cream, batch No: 2TT (pharmaceutical formulation) was used as vehicle.
Exposure duration: 8 hour(s)
Details on study design: The absorption and excretion of 14C-labelled bronopol was examined in 2 volunteers following application of a cream containing 0.1% of the test material (Soltan 3 cream) to the skin. The selected concentration was as used in a commercial product.
Details on dosing and sampling: An amount of 40 mg of radioactive substance was dissolved in 400 µl distilled water, and 4000 mg of Soltan cream was added and mixed for one minute. Further 4000 mg of Soltan cream was added and mixed until the required concentration of 0.1% bronopol was reached. The finally obtained radiolabelled test material was tested for homogeneity. Radioactivity content was assessed by means of liquid scintillation counting. About 6 µCi of the radioactive material was applied to the abdominal skin of each volunteer under occlusive conditions (application site: 200 cm2). After 8 hours following application, the abdominal application site was swabbed with water for removal of residual test material.

Results and discussion

Results of examinations:
Details on absorption: Losses of test material upon application as well as contamination of the occlusion material resulted in 29.6% and 39.9% of the total applied dose, which was unavailable to volunteer A and B, respectively.

Details on excretion: About 1.8% and 5% of the available dose of radioactivity was detected in the urine of volunteer A and B, respectively; no radioactivity was found in the faeces. After 8 hours following application, 65.7% and 92% of the available dose was removed from the abdominal skin of volunteer A and B, respectively by swabbing, The maximum amount of 14C-labelled bronopol, which could have been available systematically to the volunteers was about 34% for volunteer A and 8% for volunteer B.

Applicant's summary and conclusion