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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given, acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978

Materials and methods

Study type:
clinical case study

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Subjects:
The skin irritant effect of bronopol was tested on volunteers and on patients attending a contact dermatitis clinic.
Study with volunteers: 10 subjects/test dose
Study with patients: 149 subjects
Route of exposure:
dermal
Reason of exposure:
intentional
Details on exposure:
Study with volunteers: Single treatment on the forearms of ten subjects; Exposure: 24 h
Study with patients: Single treatment; Exposure: 48 h
Concentrations:
Study with volunteers
0, 0.5, 1 and 2% bronopol in paraffin.
0, 0.05, 0.1 and 0.25% bronopol in aqueous buffer at pH 5.5.
Study with patients:
0.25% bronopol in paraffin
Examinations:
Study with volunteers:
Skin reaction seen after 24 hours were graded from 0 (normal skin) to 5 (marked erythema with vesicles and induration).
Study with patients:
Skin was examined on the second and fourth day following application. Skin reaction was graded as described above.

Results and discussion

Results of examinations:
Study with volunteers:
Bronopol tested at 1% in paraffin resulted in slight erythema in 2/10 subjects, At 2% bronopol, moderate erythema was seen in 4/10 cases. Bronopol tested in an aqueous buffered solution at 0.25% induced slight erythema in 1/10 cases.
Study with patients:
Three of the 149 patients showed slight erythema on the second day; the reaction tended to pale on day 4. A fourth subject showed moderate erythema on the second day; no skin examination could be done on day 4 (patient did not return for examination). No evidence of sensitization was seen. No cross-sensitization with other substances including formalin was seen.

Any other information on results incl. tables

The skin irritant effect of Bronopol was examined by means of the closed patch test on volunteers and on patients attending a contact dermatitis clinic (Bryce, 1978). The volunteers were treated with following test concentrations of Bronopol: 0, 0.5, 1 and 2% bronopol in paraffin, and 0, 0.05, 0.1 and 0.25% Bronopol in aqueous buffer at pH 5.5. Ten subjects were used per test group. All 149 patients were treated with 0.25% Bronopol in paraffin. For these subjects, the compound was tested as one of a battery of closed patch test used in that clinic to screen the patient for a potential allergen. Skin reaction in volunteers was assessed after 24 hours; skin reaction in patients was assessed on the second and fourth days following a 48 h application period. Findings were graded from 0 (normal skin) to 5 (marked erythema with vesicles and induration). Bronopol tested at 1% in paraffin on volunteers resulted in slight erythema in 2/10 subjects, At 2% Bronopol, moderate erythema was seen in 4/10 cases. Bronopol tested in an aqueous buffered solution at 0.25% induced slight erythema in 1/10 cases. Three of the 149 patients showed slight erythema on the second day; the reaction tended to pale on day 4. A fourth subject showed moderate erythema on the second day; no skin examination could be done on day 4 (patient did not return for examination). No evidence of sensitization was seen. No cross-sensitization with other substances including formalin was seen. Conclusively, Bronopol was a slight to mild irritant to human skin. No sensitization and no cross-sensitization potential are expected.

Applicant's summary and conclusion