2,2-dimethoxyethylamine

Acute Toxicity: oral

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

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethoxyethylamine

EC Number:

245-026-5

EC Name:

2,2-dimethoxyethylamine

Cas Number:

22483-09-6

Molecular formula:

C4H11NO2

IUPAC Name:

2,2-dimethoxyethanamine

Constituent 2

Reference substance name:

HF 88035

IUPAC Name:

HF 88035

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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%).