Registration Dossier
Registration Dossier
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EC number: 231-195-2 | CAS number: 7446-09-5
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- other: human case
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Entry adopted from the OECD SIAR on sulfur dioxide without modification.Study meets generally accepted scientific principles, sufficient documentation of test results with statistical evaluation; less well characterisation of worker and control group, sulphite pulp mill workers with exposure to sulphur dioxide were compared to workers engaged in other processes; consideration of smoking habit; less well characterisation of exposure conditions, no data on exposure concentration and possible co-exposure to clastogenic substances; study acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Is exposure to sulphur dioxide clstogenic?
- Author:
- Nordenson, I. et al.
- Year:
- 1 980
- Bibliographic source:
- Hereditas 93: 161-164
Materials and methods
- Study type:
- biological exposure monitoring
- Endpoint addressed:
- genetic toxicity
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study reports exposure- related observations in humans.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sulphur dioxide
- EC Number:
- 231-195-2
- EC Name:
- Sulphur dioxide
- Cas Number:
- 7446-09-5
- Molecular formula:
- SO2
- IUPAC Name:
- Sulphur dioxide generated from sulphur by combustion
- Details on test material:
- no data
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Details on study design:
- Report of the results of a preliminary study of chromosomal aberrations among workers at a sulphite pulp factory in northern Sweden.
TEST GROUP:
- Number: N=19 males
- Working history: individuals working at the same sulphite pulp factory with employment for more than 15 years
SULPHUR DIOXIDE-EXPOSED GROUP (Subgroup A):
- Number: N=7
- Working history: chronically exposed to sulphur dioxide from boiling of pulp and handling of sulphuric acid, concentration not specified
- Characterisation: 1 smoker, 6 non-smokers
PULP BLEACHING GROUP (Subgroup B):
- Number: N=6
- Working history: bleaching of pulp with exposure to chlorine,
- Characterisation: 1 smoker, 5 non-smokers
PAPER MILL GROUP (Subgroup C):
- Number: N=6
- Working history: exposure to dust in the paper mill
- Characterisation: 3 smokers, 3 non-smokers
CONTROL GROUP:
- Number: N=15 males
- Characterisation: healthy subjects (no further information), N=5 smokers
GENOTOXICITY TESTS: isolation of peripheral lymphocytes and investigation of the following endpoints: chromosomal aberrations after 72 h culture. In 8 workers a second blood sample was taken one month after the first sample in order to see whether aberrations varied with time.
STATISTICAL METHODS: chi square test
Results and discussion
- Results:
- TEST RESULTS:
- Frequency of chromosomal aberrations: values for subgroups A (SO2 exposed), B (bleaching) and C (paper mill), control group:
total aberrations: 0.075 %, 0.031 %, 0.039 %, 0.027 %
gaps: 0.038 %, 0.013 %, 0.027 %, 0.021 %
chromatid aberrations: 0.021 %, 0.006 %, 0.006 %, 0.006 %
chromosome aberrations: 0.016 %, 0.011 %, 0.006 %, 0.001 %
Repeatability of results: in 8 workers within 1 month of post-observation the difference was 0.88 aberrations/100 cells, not significant
STATISTICAL RESULTS: in the sulphur dioxide exposed group (A) all types of aberrations were significantly increased in comparison to the control group with p<0.01 or p<0.001; in contrast no significant increases for groups B and C.
Applicant's summary and conclusion
- Conclusions:
- An investigation of workers in a sulphite pulp factory with employment for more than 15 years demonstrated a significant increase of structural chromosomal aberrations (CA) only in those workers with exposure to sulfur dioxide (N=7) but not in those at other workplaces. Frequencies of CA in the unexposed workers (2 groups with N=6 employed in pulp bleaching with chlorine or in the paper mill) were similar to a control group (N=15, higher frequency of smokers).
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