Bronopol

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Scientifically acceptable. Update of earlier (1980) Safety Assessment. Special emphasis on potential reactions with other ingredients, i.e. triethanolamine, which might lead to nitroso compounds, and toxicological findings related to such nitroso compounds.

Data source

Reference

Reference Type:

publication

Title:

Addendum to the Final Report on the Safety Assessment of 2-Bromo-2-Nitropropane-1,3-Diol

Author:

Anonymous

Year:

1984

Bibliographic source:

Cited in: Cosmetic Ingredient Review, Journal of the American College of Toxicology, Vol. 3, No: 3: 139-155, (Published), BPD ID B6.6_01

Materials and methods

Type of study / information:

Type: other: Review; Addendum to Safety Assessment Report Bronopol (Safety assessment of 2-bromo-2-nitropropane-1,3 -diol)

Principles of method if other than guideline:

Data on occupational exposure of worker to Bronopol

Test material

Test material information

Constituent 1

Reference substance name:

Bronopol

EC Number:

200-143-0

EC Name:

Bronopol

Cas Number:

52-51-7

Molecular formula:

C3H6BrNO4

IUPAC Name:

2-bromo-2-nitropropane-1,3-diol

Results and discussion

Any other information on results incl. tables

Twenty out of fifty bronopol exposed workers suffered from skin irritation and/or superficial burns. In 8 cases a second occurrence, in 6 cases, a third occurrence and in 3 cases, a fourth occurrence were reported. The reported findings were described as irritant reaction rather than contact allergy.

 

The earlier conclusion is reaffirmed that Bronopol is safe as a cosmetic ingredient at concentrations up to 0.1% except from circumstances where reactions with amines or amides can result in nitrosamine or nitrosamide formation.

Applicant's summary and conclusion

Conclusions:

The earlier conclusion is reaffirmed that Bronopol is safe as a cosmetic ingredient at concentrations up to 0.1% except from circumstances where reactions with amines or amides can result in nitrosamine or nitrosamide formation.

Executive summary:

In a safety assessment (Anonymous, 1984), data on occupational exposure of 50 workers to Bronopol were reported.The skin of 20/50 Bronopol exposed workers showed signs of skin irritation and/or superficial burns following exposure to saturated aqueous solutions or powder of Bronopol on at least one occasion. In 8 cases a second occurrence, in 6 cases, a third occurrence and in 3 cases, a fourth occurrence were reported. None of the concerned workers had quit the job because of these injuries. Conclusively, the reported findings were described as irritant reaction rather than contact allergy.