2-{(E)-[6-({4-chloro-6-[(4-{[2-(sulfooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonaphthalen-2-yl]diazenyl}naphthalene-1,5-disulfonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The test chemical was tested for its dermal irritation potential in New Zealand White Rabbits according to OECD guideline 404 Guidelines

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

EC Number:

239-888-1

EC Name:

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

Cas Number:

15790-07-5

Molecular formula:

C16H9AlN2O7S2

IUPAC Name:

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

Test material form:

solid

Details on test material:

- Name of test material : aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex
- Molecular formula : C16H9AlN2O7S2
- Molecular weight : 432.368 g/mol
- Smiles notation : c12c(cc(S(=O)(=O)[O-])cc2)ccc(c1\N=N\c1ccc(S(=O)(=O)[O-])cc1)[O-].[Al+3]
- InChl : 1S/C16H12N2O7S2.Al/c19-15-8-1-10-9-13(27(23,24)25)6-7-14(10)16(15)18-17-11-2-4-12(5-3-11)26(20,21)22;/h1-9,19H,(H,20,21,22)(H,23,24,25);/q;+3/p-3/b18-17+;
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Details on test animals
Age: 10 to 12 weeks
Sex:Female
Body weight range: 2.0kg±200g
Identification : By cage tag and corresponding colour body marking
Housing:Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
Diet:Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
Water:Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum
Acclimatization: The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
Randomization: After acclimatization and Veterinary examination three females were randomly selected.

Details on environmental conditions:
- Temperature (°C): temperature between 22-25 deg C
- Humidity (%): relative humidity 40-60%
- Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour,
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

HUSBANDRY
Environmental conditions :Air conditioned rooms with 10-15 air changes per hour, temperature between 19-25 0C, relative humidity 30-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Accommodation Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
Diet : Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi, India
Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles,mad-libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

intact skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

500 mg (0.5g)

Duration of treatment / exposure:

4 hours

Observation period:

60 min., 24, 48 and 72 hours after application.

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: dorsal area of trunk
- % coverage: small area (approximately 6 cm2)
- Type of wrap if used: impervious dressing which was secured in position with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure:after patch removal the test site was washed with lukewarm water

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : The intact skin site of application of each animal was observed for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after application.

SCORING SYSTEM:
- Method of calculation: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

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test compound applied at the dose level of 500mg on shaven back skin of rabbit did not produced any irritation to skin during period of observation.

Other effects:

The test compound applied on the shaven back skin of rabbit did not produce pain and any clinical signs of toxicity throughout the examination period of 14 days.

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The Primary Irritation Index (PII) for test chemical after 14 days of observation was 0.0.
Also the test chemical did not produce pain and any clinical signs of toxicity throughout the examination period of 14 days.
Hence, under the test conditions, the test chemical can be concluded to be not irritating to New Zealand White rabbit skin.

Executive summary:

A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of the test chemical. 3 female New Zealand White rabbits were used for the study. The animals were prepared 24 hours prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 500gm (0.5g) of test compound was applied on a small area (approximately 6 cm2) of intact skin site. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The intact skin site of application of each animal was observed for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after application and the responses were scored according to Draize method.

The Primary Irritation Index (PII) for the test chemical after 14 days of observation was 0.0.Also, the test chemicaldid not produce pain and any clinical signs of toxicity throughout the examination period of 14 days.

Hence, under the test conditions,the test chemical can be concluded to be not irritating to New Zealand White rabbit skin.