Registration Dossier

Toxicological information

Acute Toxicity: oral

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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: basic data given, comparable to guideline/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Testing done with BASF-internal standards
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
5 male resp. 5 female rats were used for each dose level. The mean body weight of male animals was 206 g, the mean body weight of female animals was 174 g.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test substance was given as an emulsion in 0.5% aqueous CMC solution.
Observation period: 7 resp. 14 days
Doses:
100, 464, 681, 1000, 1210, 1470, 1780, 2150, 4640, 10000 ul/kg
No. of animals per sex per dose:
5 and/or 10 (see mortality table)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 resp. 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
ca. 1 100 other: ul/kg
Remarks on result:
other: original value
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
ca. 900 mg/kg bw
Mortality:
yes (see table below)
Clinical signs:
slight apathy, partially staggering, dyspnoea, diarrheic feces, exsiccosis, abdominal and lateral position
Body weight:
normal weight gain
Gross pathology:
acute heart dilatation (both sides), acute congestive hyperemia, intra-abdominal adhesions of the stomach, thickened wall of the forestomach, partially formation of diverticulum

Any other information on results incl. tables

Mortality:

 Dose (ul/kg)  Concentration (%)  No. of animals  dead within            
       1 hour  24 hours 48 hours  7 days  14 days
 10000  35  5 males  0/5  5/5  5/5  5/5  
     5 females  0/5  5/5  5/5  5/5  
 4640  35  5 males  0/5  5/5  5/5  5/5  
     5 females  0/5  5/5  5/5  5/5  
 2150  30  10 males  0/10  10/10  10/10  10/10  
     10 females  1/10  10/10  10/10  10/10  
 1780  15  5 males  0/5  5/5  5/5  5/5  
     5 females  0/5  5/5  5/5  5/5  
 1470  15  10 males  0/10  10/10  10/10  10/10  
     10 females  0/10  10/10  10/10  10/10  
 1210  15  5 males  0/5  2/5  2/5  2/5  
     5 females  0/5  5/5  5/5  5/5  
 1000  15  5 males  0/5  1/5  1/5  1/5  
     5 females  0/5  0/5  0/5  0/5  
 681  6  5 males  0/5  0/5  0/5  0/5  
     5 females  0/5  0/5  0/5  0/5  
 464  6  5 males  0/5  0/5  0/5  0/5  
     5 females  0/5  0/5  0/5  0/5  
 100  1.5  5 males  0/5  0/5  0/5  0/5  0/5
     5 females  0/5  0/5  0/5  0/5  0/5

Applicant's summary and conclusion

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