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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
chronic toxicity: 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. Very limited reporting of study design and results.
Cross-reference
Reason / purpose:
reference to same study

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:
publication
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 test substance toxicity after 19 weeks treatment
GLP compliance:
no
Limit test:
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
Type of inhalation exposure:
not specified
Vehicle:
other: no data
Remarks on MMAD:
MMAD / GSD: no data
Details on inhalation 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
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
approx. 15.7, and 25.2 mg/m3
Basis:
other: calculated
Remarks:
Doses / Concentrations:
3 and 10 ppm
Basis:
nominal conc.
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:
none
Sacrifice and pathology:
none
Other examinations:
none
Statistics:
none

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

Effect levels

Dose descriptor:
LOAEC
Effect level:
17 mg/m³ air
Basis for effect level:
other: Inflammation of the nasal cavity was seen in both dose levels

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Inflammation of the nasal cavity was seen in rats that were exposed to the test substance in the carcinogenicity study (in both tested groups). Several deaths due to inflammation of the nasal cavity or pneumonia were reported.

Applicant's summary and conclusion