Reaction mass of Ethanaminium, 2-hydroxy-N,N-dimethyl-N-[2-[(1-oxooctadecyl)oxy]ethyl]-, chloride and Ethanaminium, N,N-dimethyl-2-[(1-oxohexadecyl)oxy]-N-[2-[(1-oxooctadecyl)oxy]ethyl]-, chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-02-02 to 2009-02-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP

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:

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

Version / remarks:

30 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 (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

MDEA Esterquat C18 satd.

IUPAC Name:

MDEA Esterquat C18 satd.

Details on test material:

- Name of test material (as cited in study report):Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride
- Physical state: solid
- Analytical purity: 98.5%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 223-240 g
- Fasting period before study: 16-19 hours
- Housing: Semi-barrier in an air conditioned room. The animals were kept in groups in IVC cages, type III H, polysulphone
cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): ad libitum (Altromin 1324 maintenance diet)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 20 - 24 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2009-02-02 To: 2009-02-20

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 % w/w
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: non-toxic characteristics
- Lot/batch no. (if required): B. Braun Melsungen, lot 7494A191, expiry date: November 2010
- Purity: aqua ad injectionem

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION (if unusual): The test item was ground to a fine dust with the help of a mortar. Then it was dissolved while stirring and heated up approx. 70 °C in the vehicle.

Doses:

2000 mg/kg bw

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 and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. The animals were weighed on day 0 (prior to the administration) and on days 7 and 14.
- 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: no mortalities

Mortality:

No deaths occured during the study

Clinical signs:

other: no signs of toxicity

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were recorded for any animal of the two steps.

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) 1272/2008)

Conclusions:

Under the conditions of the present study, the oral LD50 of MDEA Esterquat C18 satd. in female rats is > 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 (30 May 2008), 6 female, fasted, 8-12 weeks old Wistar strain rats were given a single oral dose of MDEA Esterquat C18 satd. in water (10% w/w) by gavage at the limit dose of 2000 mg/kg bw and observed for 14 days.

All animals survived until the end of the study period. No clinical signs were observed in any animal at any observation timepoint. The body weight of the animals was within the range commonly recorded for this strain and age. No test substance related macroscopic findings were recorded at necropsy.

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