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Description of key information

From the above study results, it is concluded that the chemical diiodohydroxyquinoline shall not exhibit acute toxicity by the oral, inhalation and dermal route in the concentrations mentioned in the study end points.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Qualifier:
according to guideline
Guideline:
other: estimated data
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 2.3.
GLP compliance:
no
Test type:
standard acute method
Species:
other: Rattus norvegicus
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 470.499 mg/kg bw
Based on:
test mat.





The prediction was based on dataset comprised from the following descriptors: LD50
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

(("a" and "b" ) and ("c" and "d" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(I)c(O)c2c(c(I)c1)cccn2
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as High (Class III) by Toxic hazard classification by Cramer (with extension)

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is >= 2.63

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.64

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of diiodohydroxyquinoline in Rattus norvegicus was found to be 4470.499 mg/kg of body weight.This classifies the chemical as being non toxic by oral route.
Executive summary:

The acute oral median lethal dose (LD50) of diiodohydroxyquinoline in Rattus norvegicus was found to be 4470.499 mg/kg of body weight.This classifies the chemical as being non toxic by oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 470.499 mg/kg bw
Quality of whole database:
QSAR model is considered reliable by OECD

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
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.
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.
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.
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliable study result conducted as per the OECD guidelines.

Additional information

Acute toxicity weight of evidence summary

Sr. No

End point name

Value

Test organism

Data Source

1

LD50

4470.499 mg/kg bw

Rat

QSAR

2

LD0.1 (maximum tolerated dose)

> 40000 mg/kg bw

Rat

RTECS, ACTOR

3

LDLo

300 mg/kg bw

Cat

RTECS, SAX

Justification for selection of acute toxicity – oral endpoint

Model is considered reliable by OECD

Justification for selection of acute toxicity – inhalation endpoint

The low vapour pressure of the chemical diiodohydroxyquinoline shall ensure that the exposure to vapours shall be negliglible and therefore it is expected that the chemical shall not exhibit acute toxicity by the inhalation route.

Justification for selection of acute toxicity – dermal endpoint

Reliable study result. The LD50 was found to be greater than 2000 mg/kg body weight of New Zealand White Rabbit

Justification for classification or non-classification

From the available data (from test results that followed the OECD guidelines, predictions using QSAR as well as from authoritative data sources), it is concluded that diiodohydroxyquinoline shall not exhibit acute toxicity by the oral, inhalation and dermal route upto the dose levels mentioned. Hence the substance is not classifed for acute toxicity