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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
The activity and safety of the antimicrobial agent Bronopol (2-bromo-2-nitropropan-1,3-diol).
Author:
Bryce D M, Croshaw B, Hall J E, Holland V R, Lessel B
Year:
1978
Bibliographic source:
J Soc Cosmet Chem 29: 3 - 24

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: study with patients

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: patients attending a contact dermatitis clinic
Ethical approval:
not specified
Subjects:
149 patients attending a contact dermatitis clinic
Route of administration:
dermal
Details on study design:
Concentrations: 0, 0.5, 1 and 2 % bronopol in pet., and 0, 0.05, 0.1 and 0.25 % in aqueous buffer at pH 5.5.

Results and discussion

Results of examinations:
1 % in pet. slight erythema in 2/10,
2 % in pet. moderate erythema in 4/10,
0.25% in aq. 1/10 slight erythema.
No evidence of sensitization was seen.

Applicant's summary and conclusion