Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo (69210 L'Arbresle, France)
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 163 ± 5 g (males) and 141 ± 4 g (females)
- Fasting period before study: yes (18 hours before the administration of the substance)
- Housing: groups of 5 animals of the same sex, in polycarbonate cages (48 x 27 x 20 cm)
- Diet: certified pellet diet "Rats et Souris entretien référence A04 C", ad libitum
- Water: free access to tap water filtered by 0.22 micron filter membrane
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 30 %
- Air changes: non recycled, filtered by absolute filters
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: from 12 September 1989 to 26 September 1989 (from treatment to the end of the observation period)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: -

MAXIMUM DOSE VOLUME APPLIED: 10 mg/kg
Doses:
2000, 2700, 3700, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical signs: frequently after administration and at least once a day for 14 days.
> Mortality: frequently after administration and at least twice a day for 14 days.
> Body weight: just before administration, and then on days 5, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 700 mg/kg bw
Based on:
test mat.
Mortality:
The mortality rates were 0%, 0%, 40% and 100% respectively on doses of 2000, 2700, 3700 and 5000 mg/kg bw. The death occurred within hours of treatment.
Clinical signs:
Included in the clinical signs after administration of the test substance was a slight or severe decrease in spontaneous activity both in males and females. This decrease in activity was functional to the dose administrated and had disappeared after 2 hours at 2000 mg/kg, after 48 hours at 2700 mg/kg and on day 5 at 3700 mg/kg.
Body weight:
Bodyweight gain of the treated survinving animals slowed down between day 1 and day 5 depending on the dose administrated. The bodyweight gain returned to normal thereafter.
Gross pathology:
Necropsies performed on animals found dead during the study or sacrificed at the end of the study showed no visible macroscopic anomalies.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of dimethoxy-2,2 ethylamine was higher than 2000 mg/kg bw (no mortality), but lower than 5000 mg/kg bw (100% mortality). LD50 is probably around 3700 mg/kg bw at which the mortality was 40%).
Executive summary:

Dimethoxy-2,2 ethylamine was tested for acute oral toxicity in male and female Sprague-Dawley rats by gavage according to EU testing guideline B.1 and Good Laboratory Practice.

The LD50 of dimethoxy-2,2 ethylamine was higher than 2000 mg/kg bw (no mortality), but lower than 5000 mg/kg bw (100% mortality). LD50 is probably around 3700 mg/kg bw at which the mortality was 40%).