Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-03-17 to 1986-04-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

other: Up down followed by limit test at 10,000 mg/kg bw

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

Cas Number:

1079184-43-2

Molecular formula:

n.a. (UVCB)

IUPAC Name:

Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Physical state: Solid
- Purity test date: 1986-01-22
- Expiration date of the lot/batch: 1986-06-01
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

other: BCR:WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma WickeImann, Versuchstierzucht, 4791 Borchen 1, Gartenstraße 300
- Age at study initiation: Not available
- Weight at study initiation: Male= 200 to 227 gm, female= 150 to 160.8 gm
- Fasting period before study: 18-20 hours
- Housing: Collection caging in Makrolon type III/ max.5 rats
- Diet (e.g. ad libitum): Ssniff-R Alleindiät fur Ratten pellets
- Water (e.g. ad libitum): ad libitum,Aqua fontana as for human consumption
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 2°C
- Humidity (%): 50 to 85 % different from guideline (30 - 70 %)
- Air changes (per hr): Not avialable
- Photoperiod (hrs dark / hrs light): 12 hours daily


IN-LIFE DATES: From: 1986-03-17 To: 1986-04-11

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Oleum arachidis

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 % dilution in oleum arachidis
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not available
- Lot/batch no. (if required): E-2819.01
- Purity: 80 % DEEDMAC


MAXIMUM DOSE VOLUME APPLIED: 5.7 ml


DOSAGE PREPARATION (if unusual): None


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable

Doses:

500 mg /kg bw
10000 mg /kg bw

No. of animals per sex per dose:

1 animal for 500 mg/kg bw
1 animal for 10000 mg/kg bw (up and down method)
5 males and 5 females for 10000 mg/kg bw (limit test)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 4 days for the preliminary study and 14 days for the main study
- Frequency of observations and weighing: Daily for observation ,Weighed at day 0 and at day 14 .
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed during the study at a limit dose of 10000 mg/kg bw.

Clinical signs:

other: Two of the treated animals showed slight piloerection during the first hour after application. Afterwards, they showed a normal disposition.The other animals appeared normal during the entire testing period.

Gross pathology:

No abnormality was observed during terminal necropsy.

Other findings:

- Organ weights: none
- Histopathology: None
- Potential target organs: None
- Other observations:None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of MDEA-Esterquat C16-18 and C18 unsatd. is >10000 mg/kg bw. This test material is considered to be practically non-toxic.

Executive summary:

In an acute oral toxicity study comparable to now deleted OECD guideline 401, groups of fasted,WISW rats 5 males and 5 females were given a single oral dose of  

MDEA-Esterquat C16-18 and C18 unsatd. (40 % w/w a.i.) in oleum arachidis at a dose of 10 000  mg/kg bw.

oral LD50       Males >  10 000 mg/kg bw

                       Females >  10 000 mg/kg bw

                       Combined > 10 000 mg/kg  bw

 No mortality occurred in this limit test.

MDEA-Esterquat C16-18 and C18 unsatd. is practically non-toxic based on the LD50 combined of > 10 000 mg/kg bw.

There were no treatment related clinical signs, necropsy findings or changes in body weight. A slight piloerrection was observed in 2/10 animals during the first hour after application. Afterwards they showed a normal disposition.