N,N-dimethyloctanamide

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:

other: Well conducted and documented study according to current guidelines under GLP. Original report only in german.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Mixture of 60% N,N Dimethyloctanamide, 40% N,N Dimethyldecanamide

IUPAC Name:

Mixture of 60% N,N Dimethyloctanamide, 40% N,N Dimethyldecanamide

Details on test material:

Mixture of N,N-Dimethyloctanamide and N,N-Dimethyldecanamide
color/state: yellow liquid
boiling point: circa 250°C
density: 0.88 kg/l (25°C)
unsoulable in water

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht, Strain: Hoe: WISKf(SPF71)
- Age at study initiation: 7 weeks (male), 8 weeks (female)
- Weight at study initiation: 177g (male), 179g (female)
- Fasting period before study: 16h prior and 4h after dosing
- Housing:airconditioned room, housed in macrolon cages (Tpy 4) on wood chips in group of 5 animal
- Diet (e.g. ad libitum): Altromin 1324, ad libitum
- Water (e.g. ad libitum): Tap water from plastic bottles, ad libitum
- Acclimation period: no, as animals were received from own breeding

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%):50±20%
- Photoperiod (hrs dark / hrs light): 12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame (seed) oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: adapted to 2000mg/kg bw
- Amount of total volume applied to animal (if gavage): 10ml/kg bw
- Concentration (w/v): 20%

MAXIMUM DOSE VOLUME APPLIED: 10ml/kg bw

DOSAGE PREPARATION (if unusual): The test item was mixed with sesame seed oil, homogenicity and stability in the vehicle was verified.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: due to the assumed low toxicity of the test item the highst dose was conducted as a limit test

Doses:

2000mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

one female died on application day

Clinical signs:

other: Unspecific symptoms, adverse effects on motion sequence, respiration and reflexes were observed. The animal showed also abdominal and letaral position, lid narrows, epiphora, reduced surface temperature and signs of stupor.

Gross pathology:

Necropsy of died animal shows liver colouring and lobular pattern and diffuse redness of the gastric mucosa. Necropsy of the survived animals reveals no macroscopic visible alteration.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU GHS

Conclusions:

An LD50 above 2000mg/kg bodyweight can be concluded from the experiment.

Executive summary:

To investigate the acute oral toxicity of Hoe S 4166 the test substance was applied via gavage to male and female wistar rats according to OECD 401 under GLP.

One female died in the 2000 mg/kg on application day. Additional to unspecific symptoms adverse effects on motion sequence, respiration and reflexes were observed. The animal showed also abdominal and letaral position, lid narrows, epiphora, reduced surface temperature and signs of stupor. On day 7 after application all surviving animals were free of symptoms. The body weight gain was not affected.

In result a Dosis letalis media (LD50) above 2000mg/kg bodyweight can be drawn from the experiment.

Necropsy of died animal shows liver colouring and lobular pattern and diffuse redness of the gastric mucosa. Necropsy of the survived animals reveals no macroscopic visible alteration.