Ethyltris(2-hydroxyethyl)ammonium ethyl sulphate

Endpoint summary

Description of key information

Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is, according to OECD Guideline 423, Annex 2: LD50 cut-off (rat): 5000 mg/kg bw.

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:

2017

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

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

Name: Ethyltris(2-hydroxyethyl)ammonium ethyl sulphate
Product Description: Triethanolamine DES Quat
CAS No.: 31774-90-0
Physical state: colourless to yellow viscous liquid at 20 °C
Batch No.: PFS-755-175
Re-certification date of batch: 21 April 2018
Purity: 100 % (UVCB, water content 0.33 % (w/w))
pH, 5% in water 7.85
Acid Value , mg KOH/g 38.45
Moisture, % 0.33
Total Amine, mg/g 33.10
Viscosity,cps, #4@60,25C 1580
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Test System

Species/strain: WISTAR rats Crl: WI(Han)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female (non-pregnant and nulliparous)
Number of animals: 3 per step
Age at thebeginning of the study: 8-10 weeks
Body weight on the day of administration:
Step1: animals no. 1 - 3 : 154 - 166 g;
Step2: animals no. 4 - 6 : 177 - 180 g;
the animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare [8] the animals were bred for experimental purposes. This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.

Housing and Feeding Conditions

- Full barrier in an air-conditioned room
- Temperature: 22 +- 3 °C
- Relative humidity: 55 +- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test item was administered at a single dose by gavage using a feeding tube. The test item was administered at a dose volume of 10 mL/kg body weight.
Vehicle: Aqua ad injectionem (sterile water). This vehicle was chosen due to its non-toxic characteristics

Doses:

Preparation of the Test Item

In order to get the test item in a solution or suspension, which is applicable to the animals, aqua ad injectionem (sterile water) was evaluated as vehicle and was considered to be adequate. The test item was weighed out into a tared plastic vial on a precision balance. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration. For all animals of the first step and of the second step, 2.0 g of the test item was dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. The dose formulations were made shortly before each dosing occasion.

No. of animals per sex per dose:

Six animals, three animals per step;

Control animals:

no

Statistics:

not specified

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.

Clinical signs:

other: Under the conditions of the present study, a single oral application of the test item N-Ethyl-2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium ethyl sulfate to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. N

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Other findings:

No other specific findings were recorded for any animal.

Results

Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was dissolved in the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg. All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study without showing any test-item related signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step.

Table 1: LD50 Cut-Off

Starting does (mg/kg bw)	Number of animals	Number of intercurrent death	LD50 Cut-Off
2000	6	0	5000 mg/kg bw

Table 2: Absolute Body Weights in g and Body Weight Gain in %

Step	Animal No. / Sex	Starting dose (mg/kg bw)	Body weight (g)			in comparison to day 1 (%)
			Day 1	Day 8	Day 15	Day 15
1	1 / female	2000	166	200	212	28
1	2 / female	2000	158	187	207	31
1	3 / female	2000	154	174	287	21
2	4 / female	2000	180	205	213	18
2	5 / female	2000	177	204	223	26
2	6 / female	2000	180	207	213	18

None of the animals showed weight loss during the observation period.

No specific findings during the whole observation period.

No specific gross pathological changes were recorded for any animal.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is, according to OECD Guideline 423, Annex 2: LD50 cut-off (rat): 5000 mg/kg bw.

Executive summary:

Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is, according to OECD Guideline 423, Annex 2: LD50 cut-off (rat): 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available