Chloramide

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles.

Data source

Reference

Reference Type:

publication

Title:

Effects of drinking water monochloramine on lipid and thyroid metabolism in healthy men.

Author:

Wones R. G., Deck C.C., Stadler B., Roark S., Hogg E., and Frohman L.A.

Year:

1993

Bibliographic source:

Environmental health perspectives, vol. 99, pp. 369-374.

Materials and methods

Endpoint addressed:

repeated dose toxicity: oral

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

The protocol consisted of a 4-week dietary stabilization period during which all subjects drank distilled water buffered with sodium monophosphate to a pH of 8.5. the purposes of the baseline period to achieve stabilization on a high-fat, high-cholesterol diet and to allow the effects of prior exposure to chlorinated water to disipate. The baseline period was followed by a 4-week treatment period during which one-third of the subjects were assigned randomly to continue consuming buffered distilled water (distilled group), one-third were assigned to consume 1.5 L per day of drinking water containing 2 ppm monochloramine buffered with sodium monophosphate to a pH of 8.5 (2 ppm group), and one-third were assigned to consume 1.5 L per day of water containing 15 ppm monochloramine buffered to pH 8.5 (15 ppm group).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chloramide

EC Number:

234-217-9

EC Name:

Chloramide

Cas Number:

10599-90-3

Molecular formula:

ClH2N

IUPAC Name:

chloranamine

Details on test material:

- Name of test material (as cited in study report): Monochloramine

Method

Ethical approval:

confirmed and informed consent free of coercion received

Remarks:

The trial was conducted in the General Clinical Research Center (GCRC) at the University of Cincinnati Hospital and was approved by its Institutional Review Board. All subjects gave written informed consent to participate.

Exposure assessment:

estimated

Details on exposure:

TYPE OF EXPOSURE:
Oral: Consumption of drinking water containing monochloramine.

TYPE OF EXPOSURE MEASUREMENT: Area air sampling / Personal sampling / Exposure pads / Biomonitoring (urine) / Biomonitoring blood / other:

EXPOSURE LEVELS:
2 ppm and 15 ppm of monochloramine

EXPOSURE PERIOD:
4 weeks
POSTEXPOSURE PERIOD:

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:

Results and discussion

Results:

The short-term (4 weeks) consumption of drinking water containing 2 ppm monochloramine did not affect any parameters of lipid or thyroid metabolism in the healthy men studied. The short-term consumption of drinking water containing 15 ppm monochloramine was associated with an increase in the level of plasma apolipoprotein B, but there were no significant changes in other parameters of lipid and thyroid function.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, at a concentration of 2ppm no effect was observed for lipid or thyroid metabolism in healthy men. Drinking water monochloramine at a concentration of 15 ppm was associated with an increase in apolipoprotein B levels.

Executive summary:

The purpose of this study was to determine whether a 4-week consumption of 1.5L per day of drinking water containing monochloramine at a concentration of 2 ppm (ppm = mg/L) or 15 ppm under controlled conditions would alter parameters of lipid or thyroid metabolism in healthy men. Forty-eight men completed an 8-week protocol during which diet (600 mg cholesterol per day, 40% calories as fat) and other factors known to affect lipid metabolism were controlled. During the first 4 weeks of the protocol, all subjects consumed distilled water. During the second 4 weeks, one-third of the subjects were assigned randomly to drink 1.5 L per day of water containing 2 ppm of monochloramine, to drink 1.5 L per day of water containing 15 ppm monochloramine, or to continue drinking distilled water. Four blood samples were collected from each subject at the end of each 4-week study period. Subjects drinking monochloramine at a concentration of 2 ppm showed no significant changes in total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1, A2, or B when compared to the distilled water group. Parameters of thyroid function also were unchanged by exposure to monochloramine at this concentration. However, subjects drinking monochloramine at a concentration of 15 ppm experienced an increase in the level of apolipoprotein B. Other parameters of lipid and thyroid metabolism did not change. We conclude that consumption of drinking water containing 2 ppm of monochloramine does not alter parameters of lipid and thyroid metabolism in healthy men. Consumption of water containing 15 ppm monochloramine may be associated with increased levels of plasma apolipoprotein B.