3-(isodecyloxy)propiononitrile

Endpoint summary

Description of key information

The oral LD50 of Ethernitril-C10i is above 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Approrpiate GLP study.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Isodecylethemitril (Ethernitril-C10i) was evaluated for acute toxicity by oral route in the Wistar rat according to OECD TG 401. 5 males and 5 females were dose in a limit test at 2000 mg/kg bw.

No lethality occurred. Unspecific clinical sign of impairments of respiration as well as motility, stupor and prone position were observed, and shown reversible within three days. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.

Profiling indicates that Ethernitrile-C10i can be expected to be very well absorbed following oral dosing. Therefore, exposures via dermal route cannot be expected to lead to higher toxicity.

Justification for classification or non-classification

The acute oral LD50 of Ethernitrile-C10i is greater than 2000 mg/kg bw.

More severe toxicity via dermal route cannot be not expected, and classification for acute dermal toxicity is therefore also not indicated.

 

In view of the lack of surface active properties, classification for aspiration is not indicated.