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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-11-30 to 2010-12-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

(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, C18 unsatd., Me sulfates (salts)

IUPAC Name:

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

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material: 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C18 unsatd., Me-sulfates (salts)
- Physical state: liquid
- Analytical purity: 100%

Test animals

Species:

rat

Strain:

other: White Wistar, HsdCpb: WU

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 209.9 ± 6.6 g
- Fasting period before study: overnight before application and 3 h thereafter
- Housing: 3/cage in Makrolon type IV cages
- Diet (e.g. ad libitum): Rats/mice maintenance diet 1324, Altromin, Lage, Germany, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 8/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not given; sponsor had informations on toxicity of similar substances that justified a limit test.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs immediately, 1, 3 h after administration, daily thereafter except Saturday + Sunday (day 10 + 11); weighing day 0, 7, 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

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:

0/6 animals died during the observation period

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

The necropsy of all animals showed no macroscopically visible test substance related pathologic organ findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of MDIPA Esterquat 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. 11 weeks old female White Wistar, HsdCpb: WU rats were given a single oral dose of undiluted MDIPA Esterquat C18 unsatd. (100% a.i.) at a limit dose of 2000 mg/kg bw and observed for 14 days.

No animal died during the observation period, no clinical signs were observed. The body weight development of the animals was positive and within normal range. 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