Registration Dossier
Registration Dossier
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EC number: 201-058-1 | CAS number: 77-78-1
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Original reference not yet available
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Carcinogene alkylierende substanzen. I. Alkylhalogonide, -sulfate, -sulfonate und ringgespannte heterocyclen
- Author:
- Druckrey H, Kruse H, Preussman R, Ivankovic S, Landschutz Ch
- Year:
- 1 970
- Bibliographic source:
- Zeitschr Krebsforsch 74: 241-273. Cited in: EU RAR (2002).
- Reference Type:
- secondary source
- Title:
- EU Risk Assessment Report Dimethyl Sulphate
- Author:
- European Chemicals Bureau
- Year:
- 2 002
- Bibliographic source:
- EU RAR, Volume 12. Luxembourg 2002
Materials and methods
- Principles of method if other than guideline:
- evaluation of carcinogenicity of the test substance in rats after 19-week inhalative exposure
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Dimethyl sulphate
No further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: BD II
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further details
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- BD-rats (sex unspecified) were exposed to test substance in an inhalation chamber for 130 days (no further details)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 130 days (19 weeks)
- Frequency of treatment:
- 1 hour/day, 5 day/week, 19 weeks
- Post exposure period:
- experiments were terminated after 643 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
approx. 17 and 55 mg/m3
Basis:
other: calculated
- Remarks:
- Doses / Concentrations:
3 and 10 ppm
Basis:
nominal conc.
in air
- No. of animals per sex per dose:
- 20 in the 17 mg/m3 dose group and 27 in the 55 mg/m3 dose group
- Control animals:
- no
- Details on study design:
- no additional data
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS, MORTALITY AND GROSS PATHOLOGY
Several deaths due to inflammation of the nasal cavity or pneumonia were reported.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
In the low dose group of 12 surviving animals 3 were found with malignant tumors (1 squamous cell carcinoma of the nasal epithelium, 2 nervous system tumors). In the high dose group 5/15 rats living more than 643 days developed malignant tumours: 3 squamous cell carcinomas of the nasal cavity, 1 tumor in the cerebellum, and 1 lymphosarcoma of the thorax with multiple lung metastases.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 17 mg/m³ air
- Sex:
- not specified
- Basis for effect level:
- other: The lowest dose evaluated was carcinogenic
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Any other information on results incl. tables
-
Applicant's summary and conclusion
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