(hexadecylamidopropyl)trimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

study used only to support the read-across for other endpoints

Adequacy of study:

key study

Study period:

2012-05-31 to 2012-06-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

May 2008

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]stearamide

EC Number:

231-609-1

EC Name:

N-[3-(dimethylamino)propyl]stearamide

Cas Number:

7651-02-7

Molecular formula:

C23H48N2O

IUPAC Name:

N-[3-(dimethylamino)propyl]octadecanamide

Test material form:

solid: pellets

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Fasting period before study: overnight prior to dosing and until approximately 1 hour after the second administration of the test substance
- Housing: 3/cage- Diet (e.g. ad libitum): pelleted rodent diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Air changes (per hr): app. 15/h
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10% w/w
- Amount of vehicle (if gavage): 10 mL/kg bw

DOSAGE PREPARATION (if unusual):
2000 mg/kg bw were achieved by administration of two times 1000 mg/kg bw, since a 20% w/w formulation was not homogenous based on trial formulations.

Doses:

2000 mg/kg bw, given as 2 dosages of 1000 mg/kg bw within 24 hours. The first on t=0 and the second on t=3 hours. Multiple dosages given within 24 hours are regarded as a single dose

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: mortality: twice daily; clinical signs: 0, 2, 4 h, daily thereafter
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

2/6 animals died on day 2 and 3, respectively

Clinical signs:

other: Clinical signs shown by the animals found dead and surviving animals included lethargy, hunched posture, uncoordinated movements, piloerection, diarrhoea, chromodacryorrhoea, pallor, and/or ptosis.The surviving animals had recovered from the symptoms betw

Gross pathology:

One female found dead showed watery-turbid fluid in the stomach and watery-clear, yellowish fluid in the small intestines. The other female found dead showed a reduced size of the spleen. Pelvic dilation of the kidneys was noted in one surviving female. Other surviving females had no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of Stearic acid 3-(dimethylaminopropyl)amide in female rats was > 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD guideline 423, adopted 17 December 2001 and EU method B.1 tris, May 2008, 6 female, fasted, 8-9 weeks old Wistar strain ratswere given a single oral dose of Stearic acid 3-(dimethylaminopropyl)amide in Propylene glycol by gavage at a dose of 2000 mg/kg bw and observed for 14 days.

The test substance was administered as 2 dosages of 1000 mg/kg bw within 24 hours. The first on t=0 and the second on t=3 hours. Multiple dosages given within 24 hours are regarded as a single dose.

2/6 animals died on day 2 and 3, respectively. Clinical signs shown by the animals found dead and surviving animals included lethargy, hunched posture, uncoordinated movements, piloerection, diarrhoea, chromodacryorrhoea, pallor, and/or ptosis.

The surviving animals had recovered from the symptoms between days 7 and 10.

The two animals found dead showed either slight weight gain or weight loss. 3/4 surviving females showed body weight loss between days 1 and 8. These animals again gained body weight between days 8 and 15. One surviving female showed body weight gain that was considered to be similar to that expected of normal untreated animals of the same age and strain.

One female found dead showed watery-turbid fluid in the stomach and watery-clear, yellowish fluid in the small intestines. The other female found dead showed a reduced size of the spleen. Pelvic dilation of the kidneys was noted in one surviving female. Other surviving females had no macroscopic abnormalities.

 

Oral LD50 (rat, females) > 2000  mg/kg bw