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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: basic information given; poor study description

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
Bio-Test lab. internal guidelines
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
other: abraded skin
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
no details given
Duration of exposure:
14 days
Doses:
200, 794, 3160 mg/kg
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
no data
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 794 - < 3 160 mg/kg bw
Mortality:
3160 mg/kg: 4/4; 794 and 200 mg/kg: 0/4
Clinical signs:
The test material was severely irritating to the skin of the albino rabbit at the 200 and 794 mg/kg dose levels.
Skin changes in rabbits dosed at 200 mg/kg were characterized by pale red erythema and moderate edema at 24 hours; second degree burns, focal escharosis and mild desquamation at day 7; and focal escharosis and mild desquamation at day 14. Skin changes in rabbits dosed at 794 mg/kg were characterized by pale red to red, well-defined erythema, severe edema, subdermal hemorrhaging and focal second and third degree burns at 21 hours;and escharosis and moderate desquamation at days 7 and 14.
Pharmacotoxic symptoms see table below.
Body weight:
One rabbit lost weight throughout the 14-day test period (details see table below).
Gross pathology:
Necropsy examination revealed gastroenteritis and hemorrhaging in the colon in rabbit No . 1-M (200 mg/kg) ; red lungs in rabbit Nos . 5-M and 8-F (794 mg/kg); and focal discoloration of the liver and red lungs in rabbit Nos. 9-M and 10-M (3 160 mg/kg). No other gross pathologic alterations were noted except for the local skin changes as previously described.

Any other information on results incl. tables

Mortality and body weights

 Dose (mg/kg)

 Animal No.

and sex

 Individual body weights (kg)          
     Test day No.          
     0  7  14

 Number dead/

number tested

 Percent dead
 200  1 -M  2.56  2.22.  2.24  0/4  0
   2 -M  2.92  2.92  3.06    
   3 -F  3.20  3.20  3.50    
   4 -F  2.66  2.90  3.00    
 794  5 -M  3.00  3.10  3.20  0/4  0
   6 -M  2.82  2.98  2.90    
   7 -F  3.32  3.30  3.28    
   8 -F  3.30  3.42  3.32    
 3160  9 -M  2.94  (6 h)*  -  4/4  
   10 -M  2.72  (6 h)*  -    
   11 -F  3.34  (6 -22 h)*  -    
   12 -F  2.68  (6 -22 h)*      
 * time of death            

Summary of reactions

   200 mg/kg     794 mg/kg     3160 mg/kg   
   Onset  Recovery  Onset  Recovery  Onset  Recovery
 Hypoactivity  2 hours  4 hours  1.5 hours  4 hours  0.5 hours  No recovery
 Muscular weakness  -  -  1.5 hours  4 hours  1 hour  No recovery
 Lacrimation  -  -  1.5 hours  4 hours  1 hour  No recovery
 Prostration  -  -  1.5 hours  4 hours  1 hour  No recovery
 Anesthesia  -  -  1.5 hours  4 hours  1.5 hours  No recovery
 Ataxia  -  -  1 hour  4 hours  1 hour  No recovery
 Loss of righting reflex  -  -  1 hour  4 hours  1 hour  No recovery
 Salivation  -  -  -  -  1 hour  No recovery
 Rhinitis  -  -  -  -  1 hour  No recovery
 Labored breathing  -  -  -  -  1 hour  No recovery

Applicant's summary and conclusion

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