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

Endpoint summary

Description of key information

The test substance is not irritating to skin or eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliance with internation guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2.4-2.7 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. 15 g daily)
- Water: water from automatic water dispenser ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20 %
- Photoperiod: 12 hours cycle dark/light

From: 6. to 9. September 1988

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours after application of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

PREPARATION
About 24 hours before the start of the study the test eyes of all animal were examined under UV light for corneal lesion after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animal without ocular abnormalities were used for the study.

REMOVAL OF TEST SUBSTANCE
- Washing: yes with isotonic saline at 37°C
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: fluorescein; at 24 and 72 hours the eyes were also examined for corneal lesion under UV light after instillation of one drop of 0.01% fluorescein-sodium solution.

SCORING SYSTEM: according to OECD guideline 405

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

0.1

Max. score:

3

Reversibility:

fully reversible

Irritant / corrosive response data:

One hour up to 2 days after application the conjunctivae of the animal showed an evident hyperemia of the blood vessels and a slight to obvious swelling. Additionally a clear, blue colored discharge was observed. 2 days after application the signs of irritation were reversed.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % f1uorescein-sodium solution. Only animals without ocular abnormalities were used for

the study.

100 mg Reactive Blue 21 was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.

The eyes were examined 1, 24, 48 and 72 hours after application of the test substance.

At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

For skin irritation testing, each animal was treated with 0.5 g Reactive Blue 21 pasted with 0.55 mL isotonic saline. 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 entire study.

The skin of the animals was discoloured light blue 30 - 60 minutes after removal of the patches up to 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.

100 mg Reactive Blue 21 was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance.

At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

One hour up to 2 days after application the conjunctivae of the animals showed an evident hyperaemie of the blood vessels and a slight to obvious swelling. Additionally a clear, blue coloured discharge was observed one hour after application. 2 days after application the signs of irritation were reversed.

Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:

Opacity of cornea all animals 0.0; iris all animals 0.0; redness of conjunctiva all animals 0.1; chemosis of conjunctiva all animals 0.1

Testing of Reactive Blue 21 for primary eye irritation in the rabbit shows, that the substance is not irritating to the eye.