N,N-dimethyltetradecylamine N-oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-10-29 to 1997-12-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study to GLP, but report lacking some detail.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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:

N,N-dimethyltetradecylamine N-oxide

EC Number:

222-059-3

EC Name:

N,N-dimethyltetradecylamine N-oxide

Cas Number:

3332-27-2

Molecular formula:

C16H35NO

IUPAC Name:

dimethyl(tetradecyl)amine oxide

Details on test material:

- Name of test material (as cited in study report): Ammonyx MO

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley, Indianapolis, Indiana
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 206 - 260 g
- Fasting period before study: Yes, overnight
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))

IN-LIFE DATES: From: 1997-10-29 To: 1997-11-11

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Dosage volume: 5 g/kg
Metal dosing cannula

Doses:

5 g/kg bw

No. of animals per sex per dose:

5 male/5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequently on day of dosing (1, 2.5 and 4 hours) and once daily thereafter
- Necropsy of survivors performed: yes

Statistics:

Calculations of the LC50 and 95% confidence limits: Method of moving averages, Weil CC (1952) table for convenient calculations of median effective dose (LD50 and ED50) and instruction in their use. Biometrics, 8.

Results and discussion

Preliminary study:

Not performed

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 495 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortalities

Clinical signs:

other: No clinical observations reported

Gross pathology:

No treatment related effects noted at gross necropsy

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral administration of the test material resulted in an LD50 >5000 mg/kg bw, equivalent to > 1500 mg AO/kg bw.

Executive summary:

The acute oral toxicity of C14 AO was assessed in male and female rats in accordance to OECD Guideline No. 401. Five male and five female rats were dosed by oral gavage with 5000 mg/kg bw test material (ca. 30% active). After a 14 day observation period there were no mortalities and no treatment related effects observed on bodyweight or at gross necropsy. The LD50 was > 1495 mg AO/kg bw.