Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium

Endpoint summary

Description of key information

No irritating or corrosive effects

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

Study period:

since July 05,1983 to July 08,1983

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

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG,
- Weight at study initiation: 3 - 4 kg
- Housing: in individual cages in air-conditioned rooms
- Diet : Breeding diet Altromin 2013 - Rabbit (Altromin GmbH, Lage / Lippe), ad libitum
- Water : deionized water, chlorinated water from automatic watering tables, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12 hrs cycle dark/light

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: pasted with 0.25 mL PEG400

Controls:

not required

Amount / concentration applied:

500 mg pasted with 0.25 mL PEG400 apllied to shaved skin of 2.5 cm x 2.5 cm

Duration of treatment / exposure:

4 hrs

Observation period:

30 min, 24 h , 48 h , 72 h after removal of the patches

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the 4 hours exposure period


SCORING SYSTEM: according to Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 hrs

Score:

0.1

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 hrs

Score:

0

Max. score:

4

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In the experimental conditions described by OECD guidelines for the examination, acute dermal irritation / corrosivity of the substance Remazol Brillant Blue BB is described as not irritating to the skin.

Executive summary:

The examination, acute dermal irritation / corrosion in rabbits have shown in the experimental conditions described by the OECD guidelines in the patch test that the substance Remazol Brillant Blue BB after 4 hours of exposure is considered to be not irritating to the 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:

July 05,1983 to July 08,1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliance with enternational guideline.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute 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:
- Weight at study initiation: 2,8 - 3,6 kg
- Housing: in a climatizen room , inside a standard cage
- Diet : Altromin 2013 Zuchtdiat , ad libitum
- Water : deionized water with chloride , ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12 hrs cycle dark/light

Vehicle:

physiological saline

Remarks:

to form a paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
100 g

VEHICLE
0.01 mL physiol. saline

Duration of treatment / exposure:

24 Hrs

Observation period (in vivo):

72 Hrs

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : yes, with warm physiol. saline
- Time after start of exposure: 24hrs


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV-lght, fluorescein (0.01%) and slit-lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.2

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The conjunctiva at 1 h was blue discolored.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance did not show any evidence of irritation

Executive summary:

The substance Remazol Brillant Blau BB has been tested on rabbit eye in experimental condition described on OECD guidelines. The test substance did not cause irritation in rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

The acute dermal irritation / corrosion properties of Reactive Blue 220 in rabbits have been examined according to OECD 404. According to the test results, of the patch test, the test substance is considered to be not irritating to the skin after 4 hours of exposure.

The substance Reactive Blue 220 has been tested in the rabbit eye according to OECD 405. The test substance did not cause irritation in rabbit eyes.

Justification for classification or non-classification

No irritating or corrosive effects were observed in studies for skin or eye irritation.