Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

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)

Rationale for reliability incl. deficiencies:

other: GLP compliance with international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

EC Number:

277-257-2

EC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

Cas Number:

73049-92-0

Molecular formula:

not applicable

IUPAC Name:

Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Reactive Blue 21

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2.9-3.4 Kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Altromin 2123 (Altromin GmbH, Lage/Lippe) ad libitum and hay (approx. 15g daily)
- Water: water from automatic water dispenser ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20 %
- Lighting time: 12 hours daily

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g, with 0.55 ml of isotonic saline solution

Duration of treatment / exposure:

4 hours

Observation period:

examination after 30-60 minutes, 24, 48, and 72 hours.

Number of animals:

3

Details on study design:

TEST SITE
- Preparation: about 24h before the start of the study the hair in the dorsal region on the body was removed with an electric clipped over an area of 25 cm^2. Only animals with intact skin were used.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster (produced by Beiersdorf Aktiengesellschaft)

REMOVAL OF TEST SUBSTANCE
- washing: yes, with warm tap water
- Time after start of exposure: after 4 hours

SCORING SYSTEM: according to the score of Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No signs of systemic toxicity were observed during the 72 hours of observation

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In the experimental conditions described by OECD guideline 404 for evaluation of the acute dermal irritation / corrosivity of the substance Reactive Blue 21 is detemined to be not irritating to the skin.

Executive summary:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.

Each animal was treated with 0.5 g Reactive Blue 21 pasted with 0.55 mL isotonic saline. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

No signs of irritation occurred during the whole study.

The skin of the animals was discoloured partially light blue 30 minutes to 72 hours after removal of the patches at the end of the study.

Testing of Reactive Blue 21 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.