Propanenitrile, 3-[[3-(isodecyloxy)propyl]amino]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-({3-[(2-methylnonyl)oxy]propyl}amino)propanenitrile

EC Number:

919-218-0

Cas Number:

72162-47-1

Molecular formula:

C16H32N2O

IUPAC Name:

3-({3-[(2-methylnonyl)oxy]propyl}amino)propanenitrile

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Italy
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 150 - 174 g
- Fasting period before study: overnight
- Housing: solid bottomed cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 2°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% aqueous solution of carboxymethylcellulose

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: martality / morbidity twice daily; clinical signs daily; body weights on days 1, 2, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortaility observed at limit dose of 2000 mg/kg body weight

Clinical signs:

other: Unspecific clinical signs consisting of salivation, reduced activity and pilorection

Gross pathology:

No abnormalities observed at necropsy

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The registration substance is practically non-toxic following oral administration to rats. No classification & labelling necessary.

Executive summary:

The acute systemic toxicity of the registration substance was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. A first sub-group of 3 female animals was initially dosed at 2000 mg/kg (Step 1). No mortality occurred and no severe clinical signs were observed. A second sub-group of 3 female animals was then dosed at the same dose level (Step 2). No deaths occurred. Clinical signs generally observed were: salivation, reduced activity, piloerection. Two out of three animals recovered by Day 6. Piloerection, hunched posture, brown staining on the muzzle, thin appearance and rales were seen in a single animal. With the exception of one animal that showed a slightly reduced body weight gain at the end of the observation period, the changes recorded in the other treated animals were within the expected range for this strain and age of animals.No abnormalities were observed at necropsy examination performed on all animals at the end of the observation period. These results indicate that the test item did not induce mortality or severe toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.