Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate

Endpoint summary

Description of key information

The test substance is not irritating to skin and only slightly irritation to 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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g, with 0.4 mL of deionised water

Duration of treatment / exposure:

4 hours

Observation period:

examination after 30-60 minutes, 1, 2 and 3 days after removal

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. Only animals with intact skin were used.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze, covered by a piece of impermeable rubber sheeting, secured with adhesive impermeable polyethylene tape

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

Remarks on result:

other: blue staining

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

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

Other effects:

blue staining

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 198 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. Only animals with intact skin were used.

Each animal was treated with 0.5 g Reactive Blue 198 pasted with 0.4 mL deionised water. The substance was applied over the whole surface of a 2.5 x 2.5 cm covered by surgical gauze and a piece of impermeable rubber sheeting, secured with adhesive impermeable polyethylene tape

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 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 blue 3 after removal of the patches up to the end of the study.

Testing of Reactive Blue 198 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
-Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater, Manchester, UK
-Age at study initiation: between 11 and 17 weeks
- Weight at study initiation: 2.14-2.71Kg
- Housing: individually in satinised aluminium sheet cages
- Diet: Labsure CR6 Rabbit Diet ad libidum
- Water: via an automatic system ad libidum

ENVIRONMENTAL CONDITIONS
- Temperature: 16-20°C
- Humidity: 43-80 %
- Photoperiod: 12 hours cycle dark/lights maintained at a temperature

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: approx. 100mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 1

Max. score:

4

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing of Reactive Blue 198 for primary eye irritation in the rabbit showed, that the substance is slightly irritating to eyes.

Executive summary:

100 mg Reactive Blue 198 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.

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 1.1; chemosis of conjunctiva all animals 1.1

Testing of Reactive Blue 198 for primary eye irritation in the rabbit showed, that the substance is slightly irritating to the eye.

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 198 pasted with 0.4 mL deionised water. 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 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 blue 3 after removal of the patches up to the end of the study.

Testing of Reactive Blue 198 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.

100 mg Reactive Blue 198 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.

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 1.1; chemosis of conjunctiva all animals 1.1

Testing of Reactive Blue 198 for primary eye irritation in the rabbit showed, that the substance is slightly irritating to the eye.