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

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

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:

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

EC Number:

291-103-1

EC Name:

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

Cas Number:

90341-71-2

Molecular formula:

C22H14CuN4Na4O15S4

IUPAC Name:

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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Remazol-Brillantblau BB

Test animals

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

Test system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 hrs

Score:

0.1

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 hrs

Score:

0

Max. score:

4

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 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.