Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-03-14 to 1997-05-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

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:
water
Details on oral exposure:
The test substance was diluted in bedistilled water. The solutions were prepared immediately before the administration. A single dose was given,
at a volume of 10 mL/kg bw.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
In a preliminary study one female was orally administered to 2000 mg/kg bw test substance and observed for 7 days.

Main study:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least twice a day for clinical sympotmes; body weight: before administration, daily for the first three
days, then weekly and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
The necropsy included a revision of the intact animal and all its superficial tissues, followed by an observation of the cranial, thoracic and
abdominal cavities both in situ and after evisceration.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: nominal, no animal died
Mortality:
None of the animals treated at the dose of 2000 mg/kg bw died
Clinical signs:
No clinical signs were observed in the animals administered at 2000 mg/kg bw
Body weight:
All the animals administered at 2000 mg/kg bw presented a normal evolution of growth
Gross pathology:
In the necropsies carried out, the animals did not present any visible macroscopic lesions related to the treatment. The only observation made was a
dilatation of the right renal pelvis of one of the males.

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 “oleic acid-based TEA-Esterquat” was
determined to be > 2000 mg/kg bw. No animal died. No clinical signs, effects on body weight or gross pathological findings were observed.
Executive summary:

In an acute oral toxicity study (according to EU Method B 1, fixed dose procedure), 5 male and 5 female Sprague-Dawley rats were given a single oral doses of 2000 mg/kg bw “oleic acid-based TEA-Esterquat” and observed for 14 days.

Oral LD50Males and Females > 2000 mg/kg bw (nominal)

 

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

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings. The only observation made was a dilatation of the right renal pelvis of one male.