Copper dibromide

Repeated dose toxicity: oral

Administrative data

Endpoint:

chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

Bromide in drinking-water

Author:

WHO Guidelines for Drinking-water Quality

Year:

2009

Bibliographic source:

WHO

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Data from handbook

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bromide

EC Number:

231-599-9

EC Name:

Sodium bromide

Cas Number:

7647-15-6

Molecular formula:

BrNa

IUPAC Name:

sodium;bromide

Results and discussion

Effect levels

Key result

Dose descriptor:

other: ADI

Remarks:

Acceptable Daily Intake

Effect level:

0.4 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: ADI is taken for the key result

Target system / organ toxicity

Key result

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

As bromide ion is more hazardous than cupric ion, the toxicological data has been provided for bromide.

A conservative no-observed-effect level (NOEL) (for marginal effect within normal limits of EEGs in females at 9 mg/l) of 4 mg/kg bw per day gives an ADI of 0.4 mg/kg bw per day (EMEA, 1997; Sangster et al., 1986), including a safety factor of 10 for population diversity.

Executive summary:

The JMPR ADI of 0–1 mg/kg bw for bromide was set in 1966 and reaffirmed with new data in 1988. The typical daily dietary intake of bromide in the United States is 2–8 mg (Nielsen & Dunn, 2008) from grains, nuts and fish; the average bromide intake in the United Kingdom is reported as 8.4 mg/day. The intake of bromide from food would be smaller in bottle-fed infants. Bromide ion has a low degree of toxicity; thus, bromine is not of toxicological concern in nutrition. Limited findings suggest that bromide may be nutritionally beneficial; for example, insomnia exhibited by some haemodialysis patients

has been associated with bromide deficiency. A conservative no-observed-effect level (NOEL) (for marginal effect within normal limits of EEGs in females at 9 mg/l) of 4 mg/kg bw per day gives an ADI of 0.4 mg/kg bw per day (EMEA, 1997; Sangster et al., 1986), including a safety factor of 10 for population diversity. This yields an acceptable total daily intake of 24 mg/person per day, or a drinking-water equivalent value of 12 mg/l. Assuming a relative source contribution of 50%, the drinking-water value for a 60 - kg adult consuming 2 litres/day would be up to 6 mg/l; for a 10-kg child consuming 1 litre/day, the value would be up to 2 mg/l. These values apply specifically to inorganic bromide ion and not to organobromine compounds, which have individual guideline values.