Dimethyl(octyl)amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 6 June 1996 to 13 September 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: There are not desviations from the recommended guideline.

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:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl(octyl)amine

EC Number:

230-939-3

EC Name:

Dimethyl(octyl)amine

Cas Number:

7378-99-6

Molecular formula:

C10H23N

IUPAC Name:

dimethyl(octyl)amine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sprague-Dawley
- Age at study initiation: young adult
- Housing: in stainless steel grid cages
- Diet: ad libitum
- Water: ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (19-25)
- Humidity (%): 55 (40-70)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Doses:

50 and 500 mg/kg at a constant volume-dosage of 10 ml/kg in maize oil

No. of animals per sex per dose:

two groups of five male and five female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

382 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

162 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

342 mg/kg bw

Mortality:

Four male and five female animals treated at 500 mg/kg died on the day of dosing. There was no death amongst the animals treated at 50mg/kg.

Clinical signs:

other: Ante mortem signs were restricted to prone posture in one female animal. The surviving animal treated at 500 mg/kg showed underactivity, staggering gait, hunched posture and piloerection; it was overtly normal after the first over night period. There was

Gross pathology:

Necropsy of the decedents revealed areas of fur staining and cases of distension of the small intestine by a yellow viscous fluid.
There was no macroscopic abnormality detected amongst the surviving animals.

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the acute oral median lethal dosage (LD50) and slope of the dose response curve were:
Male: LD50=382 mg/kg
Female: LD50=162 mg/kg
Combined: LD50=342 mg/kg
The substance was assigned to the class "Toxic".

Executive summary:

The acute oral toxicity of the substance was investigated in two groups of five male and five female CD rats. The animals were starved overnight prior to dosing. The test material was administered at dosages of 50 and 500 mg/kg, at a constant volume-dosage of 10 ml/kg in maize oil.

Mortality and signs of reaction to treatment were recorded during a subsequent 14 -days observation period; the surviving were killed on the following day. All animals were subjected to necropsy.

Under the conditions of this study the acute oral median lethal dosage (LD50), of the test material was approximately 162 mg/kg in female animals. The substance was assigned to the class "Toxic".