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: early study report, but basic information given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
internal BASF guidelines
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
other: US rats
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2, 16 and 30% aqueous suspension with traganth
Details on oral exposure:
Observation period: 14 days
Doses:
200, 1600, 3200, 6400 mg/kg
No. of animals per sex per dose:
20
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Mortality:
see table below
Clinical signs:
3200 - 6400 mg/kg: immediately accelerated breathing, high-stepping gait, disturbed behaviour. 3 days thereafter no symptoms, then deterioration of health with crusty eyes and noses, intermittent breathing and with intensively ruffled fur. The animals were apathic and huddled. Approx. 10 days after start of the study the surviving animals recovered and 14 days after the beginning of the study they showed no more symptoms.
1600 - 200 mg/kg: immediately accelerated breathing and high-stepping gait. In the course of the same study day no more symptoms, after 3 days all animals without symptoms.
Body weight:
no data
Gross pathology:
Sacrificed animals: no abnormalities detected.

Any other information on results incl. tables

Dose (mg/kg)   Concentration (%)  No. of animals  Dead animals after            
       1 hour  24 hours  48 hours  7 days  14 days
 6400  30  20  0/20  0/20  0/20  3/20  4/20
 3200  30  20  0/20  0/20  0/20  1/20  1/20
 1600  16  20  0/20  0/20  0/20  0/20  
 200  2  20  0/20  0/20  0/20  0/20  

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU