(2-hydroxypropyl)trimethylammonium 2-ethylhexanoate

Endpoint summary

Description of key information

The oral LD50 of Solvent-free Dabco TMR is greater than 2000 mg/kg of body weight in rats (OECD 423)

A non-guideline study on the oral acute toxicity of 75% Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate solution in ethyleneglycol was tested with male albino rats of the Sherman-Wistar Strain. Study determined LD50=2.8 ml/kg b.w. (equivalent to 2800 mg/kg bw)

Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate 75% in Ethyleneglycol was tested for acute dermal toxicity on rabbits. The LD50 was > 2 000 mg/kg b.w.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

2016 Guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Waiver on basis of substance corrosivity.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

no guideline followed

Principles of method if other than guideline:

One group of ten albino rabbits weighing between 2.5 and 3.5 kg each were employed in this study.
All animals had their backs clipped free of hair 24 hours prior to testing. One half of the animals had their backs abraded prior to dosing.
The sample was dosed as supplied. 2.0 g/kg dosage was administered.
All rabbits were weighed and the correct amunt of experimental material was applied to the back of each animal. These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
The dressings were removed after twenty-four hours and any excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Sex:

not specified

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

All animals had their backs clipped free of hair 24 hours prior to testing. One half of the animals had their backs abraded prior to dosing.
The sample was dosed as supplied. 2.0 g/kg dosage was administered.

Duration of exposure:

24 h

Doses:

2 g/kg b.w.

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

One group of ten albino rabbits weighing between 2.5 and 3.5 kg each were employed in this study.
All animals had their backs clipped free of hair 24 hours prior to testing. One half of the animals had their backs abraded prior to dosing.
The sample was dosed as supplied. 2.0 g/kg dosage was administered.
All rabbits were weighed and the correct amunt of experimental material was applied to the back of each animal. These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
The dressings were removed after twenty-four hours and any excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities.

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Not available

Gross pathology:

Not available

Other findings:

Not available

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate 75% in Ethyleneglycol was tested for acute dermal toxicity on rabbits. Test determined LD50 > 2 000 mg/kg b.w.

Executive summary:

Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate 75% in Ethyleneglycol was tested for acute dermal toxicity on rabbits. Test determined LD50 > 2 000 mg/kg b.w.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

1975 non-guideline study on product containing test substance.