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Toxicological information

Carcinogenicity

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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:
1970
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:
2002
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dimethyl sulphate
No further data

Test animals

Species:
rat
Strain:
other: BD II
Sex:
not specified
Details on test animals 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