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Toxicological information

Acute Toxicity: oral

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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:
other: 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:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: nominal
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 480 mg/kg bw
Remarks on result:
other: based on a.i.
Mortality:
No deaths occurred at the dose levels of 2000 and 5000 mg/kg during the observation period.
Clinical signs:
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 hours. From day 2 to day 15, no clinical signs were observed.
Body weight:
The body weight gain of the animals was normal at 2000 mg/kg and of the females at 5000 mg/kg. A slight slowed down of the body weight gain was
noted between day 1 and day 5 in the males at 5000 mg/kg.
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
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 the “partially unsaturated TEA-Esterquat” (89.6 % a.i.) and observed for 14 days.

Oral LD50Males and Females > 5000 mg/kg bw (nominal)

Oral LD50Males 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.