Hexadecyldimethylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 4.1.1996 to 9.9.1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test is done under GLP and following OECD Guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decyldimethylamine

EC Number:

214-302-7

EC Name:

Decyldimethylamine

Cas Number:

1120-24-7

Molecular formula:

C12H27N

IUPAC Name:

N,N-dimethyldecan-1-amine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: young adult
- Weight at study initiation: males 117-141 g; females: 123-140g
- Housing: in groups of up to five by sex in solid-floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 ml/kg

Doses:

2000 mg/Kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 1 and 4 hours after dosing and subsequently once daily for 14 days.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: only 1/5 females died, no male died

Mortality:

One female animal was found dead five hours after dosing

Clinical signs:

other: Ante mortem signs were restricted to prone position

Gross pathology:

Macroscopic examination of the decedent did not reveal any abnormality. No significant lesion was evident after necropsy of the surviving animals.

Any other information on results incl. tables

	Mortality
Dosage (mg/kg)	Male	Female	Combined
2000	0/5	1/5	1/10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg in rats.

Executive summary:

The acute toxicity of the subctance was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg according to OECD guideline 401. The animals were starved overnight prior to dosing. The test material was administered 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 -day observation period; the surviving animals were killed on the following day. All animals were subjected to necropsy. Only one female rat died during the observation period.

Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.