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: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
other: acute oral toxicity study
GLP compliance:
no
Test type:
other: acute oral toxicity study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santoflex 14

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1260, 1580, 2000, 2510, 3160 mg/kg
No. of animals per sex per dose:
combined (male/females): 5 per dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 100 mg/kg bw
95% CL:
2 000 - 2 200
Remarks on result:
other: clinical signs: reduced appetide and activivty (survivors), increasing weakness, collapse and death (decedents),; gross autopsy: vicera appeared normal (survivors), hemorrhagic areas of the lung, liver discoloration, acute gastrointestinal inflammation

Any other information on results incl. tables

Mortality:

time to mortality: one to four days after application

1260 mg/kg bw: 0/3 males, 1/2 females, combined: 1/5

1589 mg/kg bw: 0/2 males, 2/3 females, combined: 2/5

2000 mg/kg bw: 0/3 males, 2/2 females, combined 2/5

2510 mg/kg bw: 0/2 males, 3/3 females, combinded 3/5

3160 mg/kg bw: 2/3 males, 2/2 females, combinded 4/5

Signs of intoxication: reduced appetite and activity (two to four days in survivors), increasing weakness, collapse and death.

Gross autopsy decedents: hemorrhagic areas of the lung, liver discoloration, and acute gastrointestinal inflammation

Survivors (7 days): vicera appeared normal

Applicant's summary and conclusion

Executive summary:

LD50 rat: 2100 mg/kg bw