Amides, C16-18, N-[3-(dimethylamino)propyl]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-10-09 to 2013-12-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-18 (even numbered), N-[(dimethylamino)propyl]

EC Number:

940-123-5

Cas Number:

866889-74-9

IUPAC Name:

Amides, C16-18 (even numbered), N-[(dimethylamino)propyl]

Details on test material:

- Name of test material: Amides, C16-18 (even numbered), N-[(dimethylamino)propyl]
- Physical state: solid
- Analytical purity: 100%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: 215 - 241 g
- Fasting period before study:
- Housing: 3/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12-18 fold
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 2013-10-23 to 2013-11-07

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

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

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: before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration, followed once daily - Frequency of weighing: weekly - Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: 2/6 animals died on day 3 and 4, respectively

Mortality:

2/6 animals died on day 3 and 4, respectively (one of three animals of each step)

Clinical signs:

other: Surviving animals showed no clinical signs

Gross pathology:

No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The oral LD50 of C16-18 DMAPA amidoamine 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, approx. 9 weeks old CD(SD) strain rats were given a single oral dose of C16-18 DMAPA amidoamine (Amides, C16-18 (even numbered), N-[(dimethylamino)propyl]) in Propylene glycol by gavage at a dose of 2000 mg/kg bw and observed for 14 days.

The test substance was administeredas 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.

1/3 animals of each step died on day 3 and 4, respectively. No other clinical signs were noted in any of the animals. All surviving animals gained the expected weight at the end of the study period. No pathological changes were observed at necropsy.

 

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