Fatty acids, C16-18 and C18-unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

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:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18(even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Cas Number:

91995-81-2 / 157905-74-3 / 93334-15-7

Molecular formula:

n.a. (UVCB)

IUPAC Name:

Fatty acids, C16-18(even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The administrations were performed in a single dose by oral route using a stainless steel round-shaped probe fitted to a 1 mL glass syringe.
The specific gravity of the test substance of 0.95 was taken into account.

Doses:

2000 and 5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

other: historical laboratory data

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signes: after administration and at least once a day thereafter; mortality: twice daily; body weight:
just before administration and then on day 5, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, after opening the thoracic and abdominal cavities,

After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs was performed:
digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities.

In the presence of macroscopic lesions, organ samples will be taken and histological examination will be performed.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 480 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths occurred at the dose levels of 2000 and 5000 mg/kg during the observation period.

Clinical signs:

other: No clinical signs were observed in the animals treated at the dose level of 2000 mg/kg bw. Hypokinesia was noted only in the treated males at the dose level of 5000 mg/kg bw, 30 minutes and one hour after treatment, then in all the animals after 2 and 4 h

Gross pathology:

Due to the absence of macroscopic lesions, no organ samples were taken and no histological examination was performed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

On the basis of the results obtained after a single oral administration, the oral LD50 of the test article “partially unsaturated TEA-Esterquat” was determined to be > 5000 mg/kg bw (nominal).

Executive summary:

In an acute oral toxicity study (according to EU Method B 1), 5 Sprague-Dawley rats/sex/dose were given single oral doses of 2000 or 5000 mg/kg bw of partially unsaturated TEA-Esterquat (89.6 % a.i.) and observed for 14 days.

Oral LD50 Males and Females > 5000 mg/kg bw (nominal)

Oral LD50 Males and Females > 4480 mg/kg bw (based on a.i.)

 No animal died. No clinical signs or effects on body weight were observed at 2000 mg/kg bw.

Hypokinesia was noted only in the treated males at the dose level of 5000 mg/kg bw, 30 minutes and one hour after treatment, then in all the animals after 2 and 4 hours. From day 2 to day 15, no clinical signs were observed at the dose level of 5000 mg/kg bw. These findings were accompanied by a slight slowed down of the body weight gain between day 1 and day 5 in the males at 5000 mg/kg bw. Normal weight gain was observed in the female 5000 mg/kg bw group.

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.