3-(isodecyloxy)propiononitrile

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(isodecyloxy)propiononitrile

EC Number:

264-840-1

EC Name:

3-(isodecyloxy)propiononitrile

Cas Number:

64354-92-3

Molecular formula:

C13H25NO

IUPAC Name:

3-(decylalkyl-(branched)oxy)-propiononitrile

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 = 178g (= 100 %)
s = ±7g
min = 167g (- 6.2 %)
max = 184g (+ 3.4 %)
n = 5
female animals
mean = 176g (= 100 %)
s = ±5g
min = 172g (- 2.3 %)
max = 184g (+ 4.5 %)
n = 5

Age at the start of the study: male animals approximately 7 weeks ; female animals approximately 8 weeks

Randomization: Randomization schemes 95.0650 and 96.0193

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'ID 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 KMnO. and cage numbering

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

The animals received the compound as a 20 % solution in sesame oil (Oleum sesami Ph. Eur. III, Fa. Mainland Pharmazeutische Fabrik GmbH), the application volume being 10 ml/kg body weight.

Doses:

2000mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The prepared test substance was administered by gavage to fasted animals at the stated dosage (2000mg/kg bw). The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the moming 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 mg/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 Isodeeylethernitril: decreased spontaneous activity, sunken flanks, squatting posture, bristled coat, stupor, stilted gait, uneoordinated or ataxie gait, prone position, irregular respira

Gross pathology:

The animals killed at the end of the observation period showed no macroseopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute oral toxicity testing of Isodecylethemitril in the Wistar rat yielded a median lethal dose (LC50) above 2000 mg/kg body weight in both male and female animals.

Executive summary:

Acute oral toxicity testing of Isodecylethemitril in the Wistar rat yielded a median lethal dose (LC50) above 2000 mg/kg body weight in both male and female animals. No lethality occurred after application of 2000 mg/kg body weight. Beside unspecific clinical signs the animals showed impairments of respiration as weil as motility, stupor and prone position. At day three of the study all c1inical signs were reversible. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.