Registration Dossier
Registration Dossier
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EC number: 214-317-9 | CAS number: 1120-71-4
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- before 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Study meets generally accepted scientific principles. Study acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,3-propanesultone
- EC Number:
- 214-317-9
- EC Name:
- 1,3-propanesultone
- Cas Number:
- 1120-71-4
- Molecular formula:
- C3H6O3S
- IUPAC Name:
- 1,2-oxathiolane 2,2-dioxide
- Details on test material:
- 1,3-Propane sultone (purity 91%)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 26 animals per group
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 32 or 60 weeks
- Frequency of treatment:
- twice a week
- Post exposure period:
- post-treatment observation period up to 60 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
28 or 56 mg/kg bw per day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 26
- Control animals:
- other: Two groups (matched and pooled): 1 of 16 males and 16 females and 1 of 26 males and 26 females, respectively
- Positive control:
- no
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 28 mg/kg bw group 52 w survival male 62%, female 39%. 56 mg/kg bw group 52 w survival male 15%, female 23%.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 28 mg/kg bw group 52 w survival male 62%, female 39%. 56 mg/kg bw group 52 w survival male 15%, female 23%.
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- cerebral and other tumors elevated by a factor of approx. 10
- Relevance of carcinogenic effects / potential:
- According to the American Conference of Governmental Industrial Hygienists (ACGIH) the substance is a confirmed animal carcinogen with unknown relevance to humans
Any other information on results incl. tables
Administration of the high dose stopped at w 32 because of high mortality and numerous mammary tumours
Applicant's summary and conclusion
- Conclusions:
- Carcinogenous
- Executive summary:
The substance is a confirmed animal carcinogen with unknown relevance to humans
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