Registration Dossier
Registration Dossier
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EC number: 201-058-1 | CAS number: 77-78-1
Repeated dose toxicity: inhalation
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 for cross-reference:
- 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:
- 1 970
- 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:
- 2 002
- 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 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
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
