Registration Dossier

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:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,3-Propane sultone (purity 91%)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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