Registration Dossier

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was conducted according to an internal BASF method. Several groups of 5-10 mice per sex and dose were treated intraperitoneally with preparations of the test substance in aqueous emulsion with traganth.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
mouse
Strain:
other: Tuebinger
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BASF AG

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: aqueous emulsion with traganth
Doses:
1.6, 0.8, 0.4, 0.2, 0.1, and 0.05 mL/kg bw (corresponding to 1392, 696, 348, 174, 87, and 43.5 mg/kg bw)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination.
Statistics:
On the basis of the observed lethality, the LD50 value was estimated using a graphical evaluation of the dose response curve on probability paper.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 700 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Exposure time: 336 hour(s)
Mortality:
The number of late deaths was noteworthy. Most deaths occurred between the first and the sixth day of the study. Then, on the tenth day after administration of the test compound another four animals died. The surviving animals recovered during the observation period between day 7 and 12.
Clinical signs:
The animals of the two highest dose groups showed at the day of administration stagger, ataxia, tonic muscle flaccidity, and in some animals also sedation. The other animals were only calmer than usual. On the following days, apathy, stagger, piloerection and in part adhering eye lids were observed.
Gross pathology:
Gross-pathological examination of the animals which had died during the course of the study and of the animals sacrificed at the end of the experiment revealed intraperitoneal adhesions and agglutinations. 11 abscesses in the abdominal wall and one liver abscess were found.

Any other information on results incl. tables

Mortality:

Dose Cumulative mortality after
[mg/kg bw] 1 h 24 h 48 h 7 d 14 d
-----------------------------------------------------------
1392 0/10 1/10 1/10 10/10 10/10
696 0/10 1/10 2/10 6/10 7/10
348 0/10 0/10 0/10 0/10 0/10
174 0/20 0/20 0/20 0/20 1/20
87 0/20 0/20 0/20 0/20 1/20
43.5 0/10 0/10 0/10 0/10 1/10
-----------------------------------------------------------

Applicant's summary and conclusion