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Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study does not totally comply with the specific testing guideline, but reasonably well-documented biomonitoring study.

Data source

Reference
Reference Type:
publication
Title:
External and internal antimony exposure in starter battery production.
Author:
Kentner M., Leinemann M., Schaller K-H., Weltle D. and Lehnert G.
Year:
1995
Bibliographic source:
Int Arch Occup Environ Health, 67: 119-123

Materials and methods

Study type:
other: health record from industry
Endpoint addressed:
basic toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A group of workers, working in the production of lead batteries, was examined with regard to the antimony concentration in blood and urine.
Aim of the study was to find out if there are any differences in the resorption and elimination kinetics between various Sb compounds resulting from
the production process.
GLP compliance:
no
Remarks:
not applicable

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Type of population:
occupational
Ethical approval:
confirmed, but no further information available
Details on study design:
METHOD OF DATA COLLECTION
- Type: Clinical tests
- Details:
The collection of the urine samples was conducted after at least 3 work days at the beginning (U1) and the end (U2) of the fourth or fifth work day (duration of the shift: 7.2 hours). During U2 venous blood samples were also collected. During the same shift personal air sampling was carried out. After the following weekend without Sb exposure the third urine sample was collected at the beginning of the first shift (U3). According to the change in shifts worked (early, normal or late), 54-104 hours lay between samples U2 and U3.

STUDY POPULATION
A group of workers from the casting area and from the formation was examined. The two groups showed no substantial differences with respect to age, occupational duration or smoking habits.
- Total population (Total no. of persons in cohort from which the subjects were drawn):
- Total number of subjects participating in study: 21 workers
- Sex/age/race: see table 1
- Smoker/nonsmoker: see table 1

- no other details on study design
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: antimony in the air


TYPE OF EXPOSURE MEASUREMENT: Area air sampling / Personal sampling
Antimony in the air was assessed by personal air sampling (P 4000, Fa. Dupont) with a velocity rate of 1.25 m/s over 3 hours. As an absorptions
medium a filter-cassette containing a cellulose acetate membrane filter (pore size 0.8 µm) was used. The filter was impregnated with a 2.5%silver
nitrate solution. Silver nitrate traps the volatile stibine as silver antimonide. In this way not only antimony trioxide dust is retained, but also volatile
stibine.

Sb was determined by hydride atomic absorption spectrometry. Air samples (Sb-A) and blood samples (Sb-B) were analysed after wet oxidative
digestion. The urine samples were analysed under statistical quality assurance conditions without further preparation. The Sb concentrations from
spot urine samples were adjusted to creatinine.

EXPOSURE LEVELS:
External exposure: Workers from the formation area had a 3 times higher Sb exposure than those from the casting area. The formers were exposed
to both stibine and antimony trioxide, the casting workers only to antimony trioxide.
Internal exposure: The formers had a median of 10.1 µg Sb/l blood and the casters, a median of 2.6 µg Sb/l blood. For the employees from the
formation area a median urinary antimony excretion of 15.2 µg Sb/g creatinine was found, and for those in the casting area, a median of 3.9 µg Sb/g creatinine.
The measured Sb concentration in blood and urine for both the casters and the formers were considerably above the values for occupationally non-
exposed individuals, i.e. <0.5 µg Sb/l in urine and <1 µg Sb/l in blood.

- no other details on exposure are reported

Results and discussion

Results:
Resorption and elimination kinetics: The workload of the persons occupied in the two examined areas was equivalent. Higher Sb-B and Sb-U levels in
the formation area can be largely ascribed to higher external Sb-A levels at the workplace and not to higher respiratory volume. With respect to Sb-A as well as Sb-B and Sb-U, the values of the formers were generally between 3 and 4 times higher than those of the casters.
Resorption coefficients (Sb-A/Sb-B) could be calculated. For the casters this factor amounted to 1.74 and for the formers to 1.22. The elimination
coefficient (Sb-B/Sb-U) showed even better agreement, with 0.68 for the casters and 0.66 for the formers.
This study shows a correlation between Sb concentrations in air and in blood/urine.

Any other information on results incl. tables

Indications of a clinically relevant health hazard, particularly haemolysis, were not found.

Table 2: Median and minimum/maximum concentrations of antimony in the workplace air (Sb-A), in urine (Sb-U) and in blood (Sb-B) at the end of the last shift of the working week (U2).

casters

formers

min.

median

max.

min.

median

max.

Sb-A

(µg/m3)

1.2

4.5

6.6

0.6

12.4

41.5

Sb-U

(µg/g creat.)

2.8

3.9

5.6

3.5

15.2

23.4

Sb-B

(µg/l)

0.5

2.6

3.4

0.5

10.1

17.9

Applicant's summary and conclusion