Reaction product of {mixture of [poly(1~4)chlorosulfonylphthalocyaninato-N29,N30,N31,N32]copper(Ⅱ) and [poly(1~3) chlorosulfonyl (tribenzo[b,g,l]pyrido[2,3-q]-5,10,15,20-tetraazaporphyrinato-N21,N22,N23,N24)] copper(Ⅱ) and [poly(1~2) chlorosulfonyl (dibenzo[b,g(or b,l)]dipyrido [2,3(or 3,2)-l,q(or g,q)]-5,10,15,20-tetraazaporphyrinato-N21,N22,N23,N24)] copper(Ⅱ) and [monochlorosulfonyl (benzo[b]tripyrido [2,3(or 3,2)-g,l,q]-5,10,15,20-tetraazaporphyrinato-N21,N22,N23,N24)]copper(Ⅱ) }and 2-[4-(2-aminoethylamino)-6-(benzylamino)-1,3,5-triazin-2-ylamino]benzene-1,4-disulfonic acid, and ammonia water and sodium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 to 30 July 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to current OECD test guidelines and GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

E-C104

IUPAC Name:

E-C104

Details on test material:

- Name of test material (as cited in study report): E-C104
- Physical state: Blue powder, solid
- Lot/batch No.: MB-1
- Expiration date of the lot/batch: July 6, 2015
- Storage condition of test material: Room temperature, in a dark place

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 10 weeks
- Weight at study initiation: 1840 g to 2015 g
- Housing: Aluminium cages (W318xH358xD498) with stainless steel cascade racks, one animal per cage.
- Diet (ad libitum):Pellet diet (LRC4, Oriental yeast Co., Ltd.), analysed per lot: contaminants confirmed to be within acceptable limits establised by the test facility.
- Water (ad libitum): well water admixed with sodium hypochlorite (about 0.2 ppm), analysed every 6 months: contaminants confirmed to be within acceptable limits in compliance with waterworks law, Japan.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24-26.1
- Humidity (%): 50.6-73,.2
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 ml

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap: before applilcation, an Elizabeth collar was installed. The test substance (moistened with water) was placed on a patch (lint cloth) and placed on application area. The patch was fixed with a non-woven adhesive bandage and occluded by the adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cleaned with absorbent cotton moisturised with lukewarm water. Then the Elizabeth collar was removed.
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to OECD 404 for erythema and eschar formation and oedema formation. In addition the Primary Irritation Index (PII) was calculated according to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: 1 h

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: 1 h

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: 1 h

Results 4

Irritation parameter:

erythema score

Remarks:

erythema and eschar formation and oedema formation

Basis:

animal #1

Remarks:

#2,.#3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 1 h

Irritant / corrosive response data:

All individual animals at any point in time did not show any irritation.

Other effects:

No clinical signs, no abnormal body weight gain were observed in any animal throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

E-C104 had no irritation or corrosion potential on the rabbit skin under the conditions of this study (OECD 404).

Executive summary:

The acute dermal irritation or corrosion potential of E-C104 was assessed in three male New Zealand White rabbits according to OECD test guideline 404. The test substance (0.5 g) was moistened with 0.4 ml of vehicle. As a result of the 4 -hour exposure (semi-occluded application) no skin reactions were observed in any animal at any observation time. Therefore, primary irritation index (PII) was 0 and evaluated as not irritating. In conclusion, E-C104 had no irritation or corrosion potential on the rabbit skin under the conditions of the study.