Registration Dossier

Administrative data

Description of key information

The subsatnce phthalylsulfathiazole was found to be non irritating to 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)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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
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
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 14 day
Score:
0
Max. score:
0
Reversibility:
no data
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance do not have iritating properties.
Executive summary:

Skin reaction :The test compound CAS No. – 85-73-4 applied at the dose level of 0.5 gm on shaven back skin (approximately 6 cm2) of rabbit did not produced any irritation to skin during period of observation.

TABLE - 1

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

Clinical Signs :The test compound CAS No. – 85-73-4 applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity throughout the examination period of 14 days.

TABLE – 2

CLINICAL SIGNS

 

SEX

ANIMAL NO.

Time (Min.)

Time (Hours)

Time (Day)

3

1

4

24

48

72

14

 

FEMALE

 

01

N

N

N

N

N

N

N

02

N

N

N

N

N

N

N

03

N

N

N

N

N

N

N

 

N: No Clinical Signs

C: Clinical Signs Observed

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)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
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
Irritation parameter:
other: MMAS(Modified Maximum Average Draizes Test Score)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Other effects:
The test compound phthalylsulfathiazole 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.

The test compound phthalylsulfathiazole 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

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
phthalylsulfathiazole in non irritating to eye
Executive summary:

Irritation Scoring

The test compound 85-73-4 applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produce mild eye discharge and slight redness at 4 hrs of observation. All the signs of irritation were recovered after 24 hours.

Clinical Signs

The test compound 85-73-4 applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin reaction :The test compound CAS No. – 85-73-4 applied at the dose level of 0.5 gm on shaven back skin (approximately 6 cm2) of rabbit did not produced any irritation to skin during period of observation.

TABLE - 1

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

Clinical Signs :The test compound CAS No. – 85-73-4 applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity throughout the examination period of 14 days.

TABLE – 2

CLINICAL SIGNS

 

SEX

ANIMAL NO.

Time (Min.)

Time (Hours)

Time (Day)

3

1

4

24

48

72

14

 

FEMALE

 

01

N

N

N

N

N

N

N

02

N

N

N

N

N

N

N

03

N

N

N

N

N

N

N

 

N: No Clinical Signs

C: Clinical Signs Observed

Eye irritation :

Irritation Scoring : - The test compound85-73-4applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produce mild eye discharge and slight redness at 4 hrs of observation. All the signs of irritation were recovered after 24 hours.

Clinical Signs : The test compound 85-73-4 applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.

Justification for selection of skin irritation / corrosion endpoint:

Skin reaction :The test compound CAS No. – 85-73-4 applied at the dose level of 0.5 gm on shaven back skin (approximately 6 cm2) of rabbit did not produced any irritation to skin during period of observation.  

Clinical Signs :The test compound CAS No. – 85-73-4 applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity throughout the examination period of 14 days.

Justification for selection of eye irritation endpoint:

The test compound 85-73-4 applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produce mild eye discharge and slight redness at 4 hrs of observation. All the signs of irritation were recovered after 24 hours.

Justification for classification or non-classification

The substance phthalylsulfathiazole was found to be non irritating to skin and eye as per the end point study conducted on animals.