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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study containing basic data but adequate for purpose.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957
Report Date:
1957

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The study was conducted prior to development of the guideline, but is a standard acute oral toxicity study
GLP compliance:
no
Remarks:
: older study, pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further details on test material.

Test animals

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

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
The test material was administered as a 10% suspension in corn oil.
Doses:
The dose range was 200-3200 mg/kg bw.
No. of animals per sex per dose:
5 rats per dose level.
Control animals:
no
Details on study design:
The suspension in corn oil was administered orally. The rats were observed for 2 weeks after dosing. Bodyweights were recorded, and rats were observed for clinical signs and mortality.
Statistics:
No information available.

Results and discussion

Preliminary study:
No preliminary study conducted.
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
None.
Clinical signs:
Symptoms noted were weakness and ataxia.
Body weight:
Body weights were not affected.
Gross pathology:
Gross pathology was not carried out.
Other findings:
No further findings.

Any other information on results incl. tables

No further results to report.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality was seen in this study; the acute oral LD50 is therefore >3200 mg/kg bw.
Executive summary:

Groups of 5 rats were gavaged with a single dose of DMT (in corn oil) at dose levels of 200 -3200 mg/kg bw and observed for 14 days. No deaths occurred; signs of toxicity were limited to weakness and ataxia. Bodyweights were unaffected by treatment. The acute oral LD50 of DMT in the rat was therefore found to be >3200 mg/kg bw under the conditions of this study.