Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February -September 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
No. of animals per sex per dose:
20
Details on study design:
The test substance was administered by oral route at dose levels of 200 or 2000 mg/kg to 2 groups of 10 fasted Sprague-Dawley rats (5 males and 5 females in each). The test substance was administered as an aqueous solution at 200 mg/kg at a volume of 10 ml/kg, or in its original form at 2000 mg/kg taking into consideration that the specific gravity (SG) of the test substance was 0.6877. The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of the test substance. A necropsy was performed on each animal found dead during the study or sacrificed at the end of the study.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occured at 200 mg/kg. At 2000 mg/kg, a clear decrease in spontaneous activity associated with respiratory difficulties preceded the death of all animals which orccured within 2 hours of treatment.
Clinical signs:
clear decrease in spontaneous activity associated with respiratory difficulties preceded the death of all animals which orccured within 2 hours of treatment.
Body weight:
The general behaviour and body weight gain of the naimls were not affected by adminisitration of the test susbtance at 200 mg/kg.
Gross pathology:
no abnormalities at 200 mg/kg. Redness of the stomach and intestinal mucosa was observed in all of the naimlas given 200 mg/kg which were found dead during the study.

Any other information on results incl. tables


The general behaviour and body weight gain of the animals
were not affected by administration of the test substance at
200 mg/kg. No deaths occurred at 200 mg/kg.
At 2000 mg/kg, a clear decrease in spontaneous activity,
associated with respiratory difficulties, preceded the death
of all the animals, which occurred within 2 hours of
treatment.
The macroscopic examination revealed no abnormalities in the
animals given 200 mg/kg which were sacrificed at the end of
the study. Redness of the stomach and intestinal mucosa was
observed in all of the animals given 2000 mg/kg which were
found dead during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:

The LD50 of ETHYLMETHYLAMINE administered by oral route in
rats was between 200 mg/kg (0% mortality) and 2000 mg/kg
(100% mortality).
Executive summary:

The test substance was administered by oral route at dose
levels of 200 or 2000 mg/kg to 2 groups of 10 fasted
Sprague-Dawley rats (5 males and 5 females in each). The
test substance was administered as an aqueous solution at
200 mg/kg at a volume of 10 ml/kg, or in its original form
at 2000 mg/kg taking into consideration that the specific
gravity (SG) of the test substance was 0.6877.Under our experimental conditions, the LD50 of the test susbtance ETHYLMETHYLAMINE administered by oral route in rats was between 200 mg/kg (0 mortality) and 2000 mg/kg (100% mortality)