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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Diiodohydroxyquinoline
EC Number:
201-497-9
EC Name:
Diiodohydroxyquinoline
Cas Number:
83-73-8
Molecular formula:
C9H5I2NO
IUPAC Name:
5,7-diiodoquinolin-8-ol
Details on test material:
- Name of test material: diiodohydroxyquinoline
- Molecular formula: C9H5I2NO
- Molecular weight: 396.95
- Substance type: organic
- Physical state: solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age : 8 to 10 weeks
Sex : Male and female
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
No. of animals per dose group : 10 (5male & 5 female)
Acclimatization :The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.
Nutritional conditions : Animals were fasted overnight prior to test and food was offered three hours after dosing.
Environmental conditions : Air conditioned rooms with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Administration / exposure

Type of coverage:
open
Vehicle:
water
Details on dermal exposure:
DOSE FORMULATION
The test compound was moistened with distilled water and then applied at the dose level of 2000 mg/kg b.wt.
APPLICATION OF TEST COMPOUND:
The test substance was applied uniformly over an exposed area of skin. The test compound was held in contact with the skin with an impervious dressing secured in place with an adhesive tape. The animals were then housed individually in cages with a collar around the neck in order to avoid the ingestion of the test compound. After 24 hours, the dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.
Duration of exposure:
14 days
Doses:
2000 mg/kg b.wt.
No. of animals per sex per dose:
No. of animals per dose group : 10 (5male & 5 female)
Details on study design:
STUDY DESIGN:
The toxicity of the test compound Diiodohydroxyquinoline dermal administration was assessed. Five female and five male rats were used per step for each dose level. The rats were observed for incidence of mortality and signs of intoxication for 14 days after the administration of test article.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test compound Diiodohydroxyquinoline when applied dermally at the dose level of 2000 mg/kg b.wt. on Wistar albino rats did not produce any mortality during the observation period of 14 days
Clinical signs:
The test compound Diiodohydroxyquinoline did not produce any clinical signs when applied dermally at the dose level of 2000mg/kg b.wt. during the observation period of 14 days
Body weight:
The body weight of each animal was recorded on day 7th and 14th (post treatment) showed normal gain as compared to control group
Gross pathology:
NECROPSY FINDING
EXTERNAL
i.Skin- Skin and hair coat was observed wet.
ii.All external orifices- Normal
B. INTERNAL
i. Subcutaneous- No changes were observed.
ii. Superficial and deep lymph nodes- No change in mesenteric lymph node.
ABDOMINAL CAVITY
i.Opening and general examination- In the abdominal cavity all the organs were present in normal position.
ii.Spleen- No changes were recorded.
iii.Digestive system- No gross changes were observed in stomach and intestine.
iv.Liver and biliary ducts- No gross pathological changes were observed
v.Excretory system- No gross pathological changes were observed.
vi.Adrenal- Observed normal.
vii.Male/female genital organs – Showed normal colour, consistency and no inflammatory changes.
2. THORACIC CAVITY
i.Opening and general examination- Thoracic cavity was found to be normal without any fluid, mucous or blood etc.
ii.Lungs- No changes were recorded.
iii.Heart- No changes were observed in color and consistency. Heart found normal.
iv.Thyroid- Normal in shape, size and surface.
3. CRANIAL CAVITY
Brain- Normal in shape and size.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of test compound Diiodohydroxyquinoline in Wistar albino rats when applied by dermal route was found to be more than 2000 mg/kg b.wt. (> 2000 mg/kg b.wt.). From this it is concluded that the substance Diiodohydroxyquinoline is non toxic by dermal route in an acute study of 14 days
Executive summary:

The acute dermal LD50 of test compound Diiodohydroxyquinoline in Wistar albino rats when applied by dermal route was found to be more than 2000 mg/kg b.wt. (> 2000 mg/kg b.wt.). From this it is concluded that the substance Diiodohydroxyquinoline is non toxic by dermal route in an acute study of 14 days