13-Docosenamide, N-[3-(dimethylamino)propyl]-, (13Z)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2 December 2008 to 9 February 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study without any restriction

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Erucamidopropyl dimethylamine

IUPAC Name:

Erucamidopropyl dimethylamine

Constituent 2

Reference substance name:

13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-

EC Number:

604-714-9

Cas Number:

149968-48-9

Molecular formula:

not applicable (a generic molecular formula cannot be provided for this UVCB substance)

IUPAC Name:

13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-

Test material form:

other: solid lightbeige

Details on test material:

- Stability under test conditions: stable in sesame oil for 2-5 hours
- Storage condition of test material: at room temperature, light protected

Test animals

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories Ltd. Switzerland
- Age at study initiation: 11 weeks
- Weight at study initiation: 178.2 - 192.4 g
- Fasting period before study: overnight (18 to 18.5 hrs) prior dosing and 3 hours post-dosing
- Housing: in group of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 44/08 ad libitum
- Water (e.g. ad libitum): community tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/6 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: from 2 to 25 December 2008

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle:The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. Since the test item was not well soluble in water, a second trial was performed with sesame oil, where the test item was well soluble.
- Lot/batch no. (if required): batch N° 067K0069 Sigma Aldrich Chemie GmbH, Switzerland
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): The test item was first reduced into a fine powder using a pestle and a mortar. Thereafter, the pulverized test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume).

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups of animals: 3 females/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were checked for viability and clinical signs during the first 30 min and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Mortality was then checked twice daily and animals were observed for clinical signs daily during days 2-15. Animals were weighed on days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes (macroscopic observations, no organs or tissues were retained)

Statistics:

no statistical analysis was used

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: One hour after dosing, a slightly ruffled fur was noted in three out of six treated females and persisted up to the 5-hour observation. Otherwise, no clinical signs were observed in any animal at any observation.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Other findings:

No other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, as the LD50 is higher than 2000 mg/kg bw, ERUCAMIDOPROPYL DIMETHYLAMINE is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.

Executive summary:

In an acute oral toxicity study, performed according to acute toxicity class method Procedure (OECD Guideline 423; EC test method B1.tris) and in compliance with the GLP, groups of female HanRcc:WIST(SPF) rats were given a single oral dose of Erucamidopropyl dimethylamine (purity > 99%) diluted in sesame oil by gavage at the dose of 2000 mg/kg bw (Limit test). Clinical signs, mortality and body weight gain were checked for a period of up to 14 days. All surviving animals were sacrificed at the end of the study and necropsied for gross abnormalities.

 

The starting dose was stated as 2000 mg/kg bw and tested in a group of 3 female rats. As no mortality occurred and no severe clinical signs were observed,3 further fasted females were given a single oral dose of 2000 mg/kg bw. No mortality occurred in this second group. One hour after dosing, a slightly ruffled fur was noted in three out of six treated females and persisted up to the 5-hour observation. Otherwise, no clinical signs were observed in any animal at any observation. There was no effect on the bodyweight and no macroscopic findings were recorded at necropsy.

Under these experimental conditions, the LD50 in rat was determined to be higher than 2000 mg/kg bw. Therefore no classification for acute oral toxicity is required forErucamidopropyl dimethylamineneither according to the criteria of the Regulation (EC) 1272/2008 (CLP including ATP3) nor according to the criteria of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.