Registration Dossier
Registration Dossier
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EC number: 200-589-6 | CAS number: 64-67-5
Carcinogenicity
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 for cross-reference:
- 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:
- 1 970
- 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 substance name:
- Diethyl sulphate
- EC Number:
- 200-589-6
- EC Name:
- Diethyl sulphate
- Cas Number:
- 64-67-5
- Molecular formula:
- C4H10O4S
- IUPAC Name:
- diethyl sulfate
- Details on test material:
- Purification: distillation in vacuum.
Supplier: Merck
Constituent 1
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.
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