(2-hydroxypropyl)trimethylammonium 2-ethylhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

(2-hydroxypropyl)trimethylammonium 2-ethylhexanoate

EC Number:

263-502-0

EC Name:

(2-hydroxypropyl)trimethylammonium 2-ethylhexanoate

Cas Number:

62314-22-1

Molecular formula:

C8H15O2.C6H16NO

IUPAC Name:

(2-hydroxypropyl)trimethylammonium 2-ethylhexanoate

Test material form:

liquid: viscous

Specific details on test material used for the study:

Identity Solvent-free Dabco TMR Batch# meyersl.20160601
Test Article See Appendix A for Test Article Characterization.
Characterization
Supplied by Air Products and Chemicals, Inc.
Date Received 18Jul2016
Storage Room temperature and humidity
Description Clear light-yellow viscous liquid
Specific Gravity 1.04
Sample Preparation Used as received

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were received from Charles River, Raleigh NC, on 06 Sep 2016. Following an acclimation period of at least five days, healthy male and healthy, non-pregnant and nulliparous female Sprague Dawley rats were assigned to treatment groups without conscious bias.
The weight
variation of the animals used did not exceed ±20% of the mean body weight of the previously dosed animals within a sex.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

A single dose was administered orally by syringe and dosing needle.

Doses:

The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to female rats and 2000 mg/kg male rats.

No. of animals per sex per dose:

3 male and 3 female rats

Control animals:

no

Details on study design:

Animals were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects and twice daily for mortality. Body weights were recorded immediately pretest, weekly, at death and at termination.

Statistics:

N/A

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: Not measured

Gross pathology:

Gross necropsy revealed no observalbale abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

All three female and three male rats survived following the 2000 mg/kg oral dose.
No abnormal physical signs were observed among all six animals.
The animals gained body weight by study termination and the gross necropsy revealed no observable abnormalities.

The oral LD50 of Solvent-free Dabco TMR Batch# meyersl.20160601 is greater than 2000 mg/kg of body weight in rats.