Propanenitrile, 3,3'-(dodecylimino)bis-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(2-cyanoethyl)(dodecyl)amino]propanenitrile

EC Number:

605-014-6

Cas Number:

1555-62-0

Molecular formula:

C18H33N3

IUPAC Name:

3-[(2-cyanoethyl)(dodecyl)amino]propanenitrile

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species Wistar rat
Strain Hoe: WISKf(SPF71)
Origin Hoechst Aktiengesellschaft, Kastengrund,SPF breeding colony
Body weight at start of study
male animals mean = 178 g (= 100 %)
s = ±7g
min = 171 g (- 3.9 %)
max = 186 g (+ 4.5 %)
n = 5
female animals mean' = 182 9 (= 100 %)
s = ±4g
min = 178 9 (- 2.2 %)
max = 189 9 (+ 3.8 %)
n = 5
Age at the start of the study male animals approximately 7 weeks
female animals approximately 8 weeks
Randomization Randomization schemes 94.0358 and 94.0359
Animal maintenance in fUlly air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
Room temperature 22 ± 3°C
Relative humidity 50 ± 20 %
Lighting time 12 hours daily
Acclimatization at least one day (breeding at identical conditions)
Food ssniff'! R/M-H (V 1534), ad libitum
Withdrawal of food from about 16 hours before to 3 - 4 hours after treatment
Water tap water in plastic bottles, ad libitum
Animal identification fur marking with KMn04 and cage numbering

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 20% suspension in sesam oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Details on study design:

The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mL/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: The following clinical signs were observed after the application of C12-Stemnitril in males and females: decreased spontaneous activity, squatting posture, stilted gait and diarrhea. Additionally, the females showed stupor, bristled coat, sunken flanks, u

Gross pathology:

No macroscopically visible changes observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results obtained in this OECD401 study the median lethal dose value (LD50) of N,N-Di-(2-cyanoethyl)-dodecylnitrilfor the male and female Wistar rat is greater than 2000 mg/kg body weight.

Executive summary:

Based on the results obtained in this OECD401 study the median lethal dose value (LD50) of N,N-Di-(2-cyanoethyl)-dodecylnitrilfor the male and female Wistar rat is greater than 2000 mg/kg body weight.