Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: 1-(2-hydroxyethyl)pyrrolidone-2
Test substance number: XIX/367

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was administered as 2, 20 or 30% (v/v) aqueous solution.
Doses:
200, 1600, 3200, 6400 mm3/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 other: mm3/kg bw
Based on:
test mat.
Remarks on result:
other: original value
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculated from original value
Mortality:
No mortality was observed.
Clinical signs:
At the two higest dose levels: restlessness and dyspnea.
Body weight:
No details given in the study report.
Gross pathology:
No abnormalities were detected.

Applicant's summary and conclusion