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Toxicological information

Exposure related observations in humans: other data

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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 does not totally comply with the specific testing guideline, but reasonably are well-documented.

Data source

Reference
Reference Type:
publication
Title:
Genotoxic Risk and Oxidative DNA Damage in Workers Exposed to Antimony Trioxide.
Author:
Cavallo D., Iavicoli I., Setini A., Marinaccio A., Perniconi B., Carelli G. and Iavicoli S.
Year:
2002
Bibliographic source:
Environmental and Molecular Mutagenesis, 40: 184-189

Materials and methods

Type of study / information:
human data
Endpoint addressed:
genetic toxicity
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The genotoxicity of antimony trioxide in occupationally exposed workers was assessed by the sister chromatid exchange (SCE) and micronucleus (MN) tests and the enzyme (Fpg)-modified comet assay.
GLP compliance:
no
Remarks:
not applicable

Test material

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

Method

Ethical approval:
other: The Ethical Committee of the "Universita Cattalica del Sacro Cuore (UCSC)" and the Scientific Committee of ISPESL approved the human study.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE MEASUREMENT: Area air sampling
Airborne antimony trioxide was collected with personal samplers (n=41). Air was sampled in conformity with ISO 7708. Sampling was scheduled
throughout the working week. Sample preparation for analysis involved microwave digestion of filters with 69-70%HNO3. The HNO3 was then
neutralized with ammonia and Sb2O3 was dissolved with aqueous tartaric acid (2g/l). Antimony was determined by atomic absorption spectrometry
(AAS).
Air sampling was not performed in the control group.


EXPOSURE LEVELS:
The mean air concentration of antimony, expressed as elemental antimony/m*3 of air inhaled was 0.12 +/- 0.11µg/m*3 for Group A
and 0.052 +/- 0.038µg/m*3 for Group B. The difference was statistically significant. (Student`s t-test, P=0.02). The mean concentration is lower than occupational limit values (generally 0.5 mg/m+3).


EXPOSURE PERIOD:
from Monday through Friday

- no other details on exposure are stated

Results and discussion

Results:
The mean SCE and MN did not differ significantly between the three groups (A, B and control), analysed by one-way ANOVA and Dunnett´s test.
In the high dose (Group A), 11 subjects had significant levels of oxidative damage versus 5.5 expected.
After adjustment of confounding factors the measure of risk for Group A subjects compared to controls was 14.2 (P=0.002).
No other significant findings could be seen. In this study the “high exposure group” is exposed to air concentrations that is almost equivalent to
ambient air concentrations and no monitoring of the non-exposed control workers were performed for comparison.
In addition, the workers are likely exposed to a series of chemicals which had not been identified.

Applicant's summary and conclusion