Registration Dossier

Administrative data

Description of key information

From the skin and eye irritation studies conducted in New Zealand White Rabbit; the chemical diiodohydroxyquinoline is found to be non-irritating to the skin and eye.  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg±200g
No. of animals : Three
Acclimatization :The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
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
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
The 0.5 gm of test compound was applied on a small area (approximately 6 cm2) of intact skin site. The test compound was moistened with distilled water prior to application. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The treated animals were then housed individually and plastic collar was put around their necks in order to prevent access by the animal to the patch and resultant ingestion of the test product. After patch removal, the dressing and unabsorbed test product was removed and the site of application was cleaned with lukewarm water.
Duration of treatment / exposure:
14 days
Observation period:
The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application.
Number of animals:
No. of animals : Three
Details on study design:
Two healthy rabbit of body weight 1.80kg±200gm selected for study after acclimatization. The test compound in the amount of 0.5 gm was applied uniformly at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment.
After 4 hours the patch was removed and the skin reactions were graded according to Draize’s method.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0
Reversibility:
no data

INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

 

Rabbit No.

Sex

INTACT SKIN

3 Min.

4 Hours

24 Hours

48 Hours

72 Hours

14 days

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

01

F

0

0

0

0

0

0

0

0

0

0

0

0

02

F

-

-

0

0

0

0

0

0

0

0

0

0

03

F

-

-

0

0

0

0

0

0

0

0

0

0

Total

0

0

0

0

0

0

0

0

0

0

0

0

Mean

0

0

0

0

0

0

0

0

0

0

0

0

Grand Total

0.00

 

Dermal Irritation Index: 0.0/4 = 0.0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Primary dermal irritation index of diiodohydroxyquinoline was calculated as 0.00 From this result it can be concluded that the test compound diiodohydroxyquinoline is not irritant to skin at the tested dose level of 0.5 gm in New Zealand white rabbits under test condition.
Executive summary:

The Primary dermal irritation index ofdiiodohydroxyquinoline was calculated as 0.00 From this result it can be concluded that the test compound diiodohydroxyquinoline is not irritant to skin at the tested dose level of 0.5 gm in New Zealand white rabbits under test condition.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg ±200g
No. of animals : Three
Acclimatization : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
Environmental conditions : Air conditioned room 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.
Vehicle:
water
Amount / concentration applied:
A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, serves as a control
Duration of treatment / exposure:
21 days
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. Individual animal weight before and during the study was also observed
Number of animals or in vitro replicates:
No. of animals : Three
Details on study design:
Two healthy rabbits of body weight 1.80 kg ±200 gm was selected for study after acclimatization. Both eyes of rabbits were examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound.
Test compound Diiodohydroxyquinoline was applied in the amount of 0.1 g in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp.
Irritation parameter:
other: MMAS(Modified Maximum Average Draizes Test Score)
Basis:
mean
Time point:
21 d
Score:
0
Reversibility:
not specified
Remarks on result:
other: not specified
Irritant / corrosive response data:
The test compound Diiodohydroxyquinoline applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produce any clinical signs of eye irritation. Furthermore, any lesions such as pannus, staining were not recorded throughout the observation period
Other effects:
The test compound Diiodohydroxyquinoline applied in conjunctival sac of rabbits did not show any observable clinical signs such as cage side activity and pain or stress etc. throughout the observation period of 21 days.

TABLE- 1     GRADING OF OCULAR LESIONS

 

S.NO/

SEX

 

OBSERVATION

Score

Total

Total Score

1/F

 

1 hour

24hours

48 hours

72 hours

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0

Conjunctivae

A.       Redness

0

0

0

0

0

0+0+0×5=00

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

2/F

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0

Conjunctivae

A.       Redness

0

0

0

0

0

0+0+0×5=00

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

3/F

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0

Conjunctivae

A.       Redness

0

0

0

0

0

0+0+0×5=00

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

Grand total

00

Mean

0.00

Eye Irritation Scoring index

0.00

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
MMAS(Modified Maximum Average Draizes Test Score) for Diiodohydroxyquinoline was found to be 0. From this it can be concluded that the test compound Diiodohydroxyquinoline is non-irritating when applied in the amount of 0.1 g in the conjunctival sac of the rabbits under test condition
Executive summary:

MMAS(Modified Maximum Average Draizes Test Score) for Diiodohydroxyquinoline was found to be 0. From this it can be concluded that the test compound Diiodohydroxyquinoline is non-irritating when applied in the amount of 0.1 g in the conjunctival sac of the rabbits under test condition

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The Primary dermal irritation index of diiodohydroxyquinoline was calculated as 0.00 From this result it can be concluded that the test compound diiodohydroxyquinoline is not irritant to skin at the tested dose level of 0.5 gm in New Zealand white rabbits under test condition.

MMAS(Modified Maximum Average Draizes Test Score) for Diiodohydroxyquinoline was found to be 0. From this it can be concluded that the test compound Diiodohydroxyquinoline is non-irritating when applied in the amount of 0.1 g in the conjunctival sac of the rabbits under test condition

Justification for selection of skin irritation / corrosion endpoint:

Reliable study result conducted as per the OECD guidelines.

Justification for selection of eye irritation endpoint:

Reliable study result conducted as per the OECD guidelines.

Justification for classification or non-classification

As per the skin and eye irritation studies conducted according to the OECD guidelines the chemical Diiodohydroxyquinoline is clasified as not irritating to the skin and eye in the doses used in the test conditions.