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Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Very few data in this publication, no control group included, very few animals per group. The relevance of the carcinoma observed is unknown.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
cancerogene alkylierende substanzen. III Alkyl-halogenide, -sulfate, -sulfonate und ringgespannte Heterocyclen
Author:
Druckrey H, Kruse H, Preussmann R, Ivankovic S,
Year:
1970
Bibliographic source:
Z. Krebsforsch. 74: 241-270

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not a standard method, few details about the method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purification: distillation in vacuum.
Supplier: Merck

Test animals

Species:
rat
Strain:
other: BD
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
81 weeks
Frequency of treatment:
once a week
Post exposure period:
up to death
Doses / concentrations
Remarks:
Doses / Concentrations:
25 and 50 mg/kg
Basis:
no data
No. of animals per sex per dose:
12 per group, no data about sex
Control animals:
not specified

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:
No control is included in this study so the relevance of the only case of carcinoma can not be checked

Effect levels

Dose descriptor:
dose level:
Effect level:
50 other: mg/kg per week
Sex:
not specified
Remarks on result:
other: Effect type: carcinogenicity (migrated information)

Any other information on results incl. tables

Only one case of carcinoma of the forestomach was observed, and 6 rats had benign papilloma among both goups.

DES is quickly hydrolyzed in the stomach, so the level of systemic effects is low.

Applicant's summary and conclusion

Conclusions:
The relevance of this study is unknown
Executive summary:

A carcinogenicity study was performed on rat which received once a week 25 or 50 mg/kg of DES by oral gavage for 81 weeks.

1 carcinoma was observed and 6 papillomas among both groups. The relevance of the tumor is unknown.