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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Only short study summary: no details of test item (purity, stability, description), details of test system missing (no. of animals, sex, age, weight), details of administration (administration volume, dose levels, vehicle), details of response data by dose level for every test animal.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Carcinogene alkylierende Substanzen. I. Dimethylsulfat, carcinogene Wirkung an Ratten und wahrscheinliche Ursache von Berufskrebs.
Author:
Druckrey, H. et al.
Year:
1966
Bibliographic source:
Zeitschr. Krebsforsch. 68, 103-111

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were given dimethyl sulfate by gavage in order to obtain the lethal dose for the test item. Clinical signs, mortality, and macroscopic examinations were reported.
GLP compliance:
not specified
Test type:
other: no data
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 information on the test material was stated.

Test animals

Species:
rat
Strain:
other: BD-strain
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
No data
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
Examinations performed: Clinical signs, mortality, and macroscopic examinations were recorded.
No further information on the study design was stated.
Statistics:
No data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
440 mg/kg bw
Based on:
test mat.
Mortality:
The animals died between 10 - 24 hours after application of the test item.
Clinical signs:
30 min. after administration cyclic convulsions occurred, which yield a general atony. Later on breathing became shallow and foam formation at the nose opening occurred.
Body weight:
No data
Gross pathology:
The autopsy ensues haemorrhagic pulmonary oedema, liver conglomerate, and intestinal bleeding. After oral administration massive necrosis in the forestomach and stomach were observed.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (rats) of dimethyl sulfate is 440 mg/kg bw .
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is classified as harmful via the oral route.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 4.