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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : phthalylsulfathiazole
- Molecular formula : C17H13N3O5S2
- Substance type: Organic
- Physical state: Solid

Test animals

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.

Test system

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

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 14 day
Score:
0
Max. score:
0
Reversibility:
no data

Applicant's summary and conclusion

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