Phthalylsulfathiazole

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phthalylsulfathiazole

EC Number:

201-627-4

EC Name:

Phthalylsulfathiazole

Cas Number:

85-73-4

Molecular formula:

C17H13N3O5S2

IUPAC Name:

2-({4-[(1,3-thiazol-2-yl)sulfamoyl]phenyl}carbamoyl)benzoic acid

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 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.

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