3-diethylaminopropiononitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(adopted in 1996)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

(first step: 2000 mg/kg bw; second step: 200 mg/kg bw; third step: 500 mg/kg bw)

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Cited as Directive 92/69/EEC, B.1

Deviations:

not specified

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

3-diethylaminopropiononitrile

EC Number:

226-323-9

EC Name:

3-diethylaminopropiononitrile

Cas Number:

5351-04-2

Molecular formula:

C7H14N2

IUPAC Name:

3-(diethylamino)propanenitrile

Details on test material:

- Name of test substance (as cited in study report): N,N-Diethylaminopropionitril
- Analytical purity: 99.6%
- Test substance number: 96/119
- Batch number: K80/1 Hauptlauf
- Physical state: liquid (colourless)
- Storage conditions: refrigerator

Test animals

Species:

rat

Strain:

other: Wistar (CHBB:THOM) (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae, Biberach
- Age at study initiation: young adult animals
- Weight at study initiation: 150 - 300 g
- Fasting period before study: 16 h
- Housing: sinlge housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel)
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugust, Switzerland; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: olive oil DAB 10

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4.0, 10.0 and 40.0 g/100mL

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A starting dose of 2000 mg/kg bw was chosen in a first step with 3 male animals because no pronounced acute oral toxicity was expected based on the physical and chemical characteristics of the test substance.

Doses:

200, 500 and 2000 mg/kg

No. of animals per sex per dose:

3
(highest dose group: only 3 males)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals
- Frequency of weighing: before application, weekly thereafter and at the end of the study
- Necropsy of survivors performed: yes, gross pathology examination; necropsy of all animals that died before the end of the observation period
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: all animals died at 2000 mg/kg bw; none at 500 mg/kg bw

Mortality:

- 200 mg/kg bw: 0/6
- 500 mg/kg bw: 0/6
- 2000 mg/kg bw: 3/3

Clinical signs:

- 200 mg/kg bw: no clinical signs observed
- 500 mg/kg bw: Impaired general state, poor general state, dyspnoea, staggering, piloerection, tremor, exophthalmos (0 h - day 1)
- 2000 mg/kg bw: Impaired general state, poor general state, dyspnoea, staggering, piloerection (0 h - 4 h)

Body weight:

- 200 mg/kg bw: (day 0) 186 g, (day 7) 261 g, (day 13) 300 g (males); (day 0) 179 g, (day 7) 209 g, (day 13) 222 g (females)
- 500 mg/kg bw: (day 0) 183 g, (day 7) 218 g, (day 13) 226 g (males); (day 0) 170 g, (day 7) 198 g, (day 13) 209 g (females)
- 2000 mg/kg bw: (day 0) 194 g (males)

Gross pathology:

- Survivers: no abnormalities detected
- Animals that died: (glandular stomach) erosion/ulcer, black; erosion/ulcer, light red and hyperaemia

Any other information on results incl. tables

Table 1: Acute oral toxicity: clinical signs

Dose (mg/kg bw)	Females				Males
	200		500		200		500		2000
Period (P) / No. of animals (A)	P	A	P	A	P	A	P	A	P	A
Impaired general state	-	-	H0-D1	3	-	-	H0-H5	3	H0-H2	3
Poor general state	-	-	H0-H5	1	-	-	-	-	H3-H4	3
Dyspnoea	-	-	H0-D1	3	-	-	H0-H5	3	H0-H4	3
Apathy	-	-	H0-H5	1	-	-	-	-	H3-H4	3
Staggering	-	-	H1-H5	2	-	-	H0-H5	3	H0-H4	3
Tremor	-	-	H0	3	-	-	-	-	-
Piloerection	-	-	H1-D1	3	-	-	H1-H5	3	H1-H4	3
Exophthalmos	-	-	H0-H1	2	-	-	-	-	-

H = hour

D = day

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information