Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to scientifically accepted method but limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
New Zealand Albino Rabbits were dosed with single doses of 5100 or 7940 mg/kg bw for 24 hours.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Flectol flakes; no further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
corn oil
Duration of exposure:
24 hours
Doses:
5010 and 7940 mg/kg
No. of animals per sex per dose:
1
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD0
Effect level:
ca. 5 010 mg/kg bw
Based on:
test mat.
Remarks on result:
other: one male animal; no mortality
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality in a single animal at 510 mg/kg; one male and one female animal testedat 7490 mg/kg; the female animal died

Any other information on results incl. tables

One female in the 5010 mg/kg survived; in the high dose group (7940 mg/kg) one male rabbit survived and one female rabbit died after 4 days.

Signs of intoxication: reduced appetite and activity (2-4 days in survivors); the female in the high dose group showed increasing weakness, collapse and death after 4 days.

Gross autopsy descendents: Hemorrhagic areas of lungs, liver dislocation, enlarged gall bladder, slight dislocation of spleen and kidney and gastro intestinal inflammation.

Survivors (14 days): viscera appeared normal

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Executive summary:

In an early study with limited documentation one rabbit was dosed with 5010 mg/kg bw and two rabbits were dosed with 7940 mg/kg in an acute toxicity experiment. Animals were observed for 14 days. Clinical signs were noted for all animals and gross autopsy of the survivors indicated hemorrhagic areas of the lung, discoloration of liver, spleen and kidney and inflammation of the gastrointestinal tract.

The rabbit in low dose group survived and one out of twoo rabbits in the high dose group died after 4 days. No precise LD50 value can be calculated but a cut-off LD50 can be estimated to be > 5010 mg/kg bw.