1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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:

1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)

EC Number:

941-174-6

IUPAC Name:

1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)

Test material form:

other: white solid wax

Details on test material:

- Name of test material: MDIPA-Esterquat C16-18 and C18 unsatd.
- Physical state: waxy solid
- Analytical purity: 100%

Specific details on test material used for the study:

- Name of test material: MDIPA-Esterquat C16-18 and C18 unsatd.
- Physical state: solid
- Analytical purity: 100%

Test animals

Species:

rat

Strain:

other: Wistar Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 10 weeks
- Weight at study initiation:
- Fasting period before study: yes, overnight prior to dosing and until approximately 1 hour after the second administration
- Housing: in groups of 3
- Diet (e.g. ad libitum): pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany); ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 2x10 mL/kg bw within 24 h
- Justification for choice of vehicle: selected based on trial formulations performed at the testing laboratory

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION (if unusual):
Formulations (w/w) were prepared within 5 hours prior to dosing and were homogenized to visually acceptable levels.
The formulations were released from the formulation unit in a water bath containing water of 35±5°C

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines.

Doses:

2000 mg/kg bw , administered as two dosages of 1000 mg/kg bw within 24 hours (first at t=0 and second at t=4 hours)

No. of animals per sex per dose:

6 females (each dose group consisted of 3 animals)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: twice daily; Clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter; weighing: days 1 (pre-administration), 8 and 15
- 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 mortality was observed

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture was noted for all animals (with piloerection for one animal) on days 1 and 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of MDIPA-Esterquat C16-18 and C18 unsatd. in female rats was >2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD guideline 423 (17 December 2001) and EU method B.1 tris (30 May 2008), 6 fasted, approx. 10 weeks old female Wistar Crl:WI (Han) rats were given an oral dose of MDIPA-Esterquat C16-18 and C18 unsatd. (100% a.i.) at a limit dose of 2000 mg/kg bw administered as two dosages of 1000 mg/kg bw within 4 h. Animals were then observed for 14 days.

No animal died during the observation period, hunched posture was noted for all animals (with piloerection for one animal) on days 1 and 2.

The body weight development of the animals was within normal range for animals of the same age and strain. The necropsy at the end of the observation period showed no macroscopically visible test substance related pathologic organ findings.

Oral LD50 Females > 2000 mg/kg bw