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: Comparable to guideline study with acceptable restrictions

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:
BASF-Test: 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 test material (as cited in study report): Ditridecylamin techn.
- Physical state: liquid

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.1 - 30% emulsion with traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.1-30% emulsion with tragacanth gum

MAXIMUM DOSE VOLUME APPLIED:
6400 mm3/kg
Doses:
200, 1600, 2000, 2500, 3200, 4000, 5000, 6400 mm³/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 700 mg/kg bw
Remarks on result:
other: Original data: 3300 mm³/kg
Mortality:
200 mm3/kg bw group: no deaths occurred
1600 mm3/kg bw group: 1/10 males died, no females died
2000 mm3/kg bw group: no males died, 3/10 females died
2500 mm3/kg bw group: 1/10 males died, 6/10 females died
3200 mm3/kg bw group: 1/10 males died, 8/10 females died
4000 mm3/kg bw group: 6/10 males died, 10/10 females died
5000 mm3/kg bw group: 6/10 males died, 10/10 females died
6400 mm3/kg bw group: 10/10 males died, 10/10 females died
Clinical signs:
Dyspnea, apathy and diarrhea
Gross pathology:
Sporadically, considerable injection of the gastric vessels

Applicant's summary and conclusion