Reaction product of disodium 4,4'-dinitrostilbene-2,2'-disulphonate, p-[(4-amino-2,5-xylyl)azo]benzenesulphonic acid, 3-[(4-amino-2-methoxyphenyl)azo]-4-hydroxybenzenesulphonic acid, copper (II) sulfate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 17, 1978 to May 1, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate

EC Number:

943-210-6

Molecular formula:

Not applicable. UVCB Substance

IUPAC Name:

tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Ace Animals, Boyertown, Pennsylvania- Weight at study initiation: 2.0 and 3.1 kgThe animals were fed, housed and maintained in accordance with standard laboratory procedures

Administration / exposure

Type of coverage:

open

Vehicle:

not specified

Details on dermal exposure:

TEST SITE- % coverage: 30 % of each animal's skin surfaceREMOVAL OF TEST SUBSTANCE- Washing (if done): yes , with warm water- Time after start of exposure: 24 hours after the star

Duration of exposure:

24 hours

Doses:

3000 mg/kg bw

No. of animals per sex per dose:

3 per sex per dose

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: daily- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 3 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 2 700 mg/kg bw

Based on:

act. ingr.

Clinical signs:

There were no adverse clinical signs observed in any of the six animals throughout the study

Body weight:

Individual body weight fluctuations presented no consistent pattern of significance.

Gross pathology:

Necropsies revealed all organs to be within normal limits.

Any other information on results incl. tables

All animals exhibited erythema and edema on day one. On day 2, two animals showed oedema and two animals showed erythema. On the 3rd day of scoring, two animals displayed oedema and one animal displayed erythema. This lasted until day four. On day 5 and 6, one animal showed oedema and one animal showed erythema. By day 7, all animals were normal and remained so throughout the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not classified according to CLP Regulation (EC n. 1272/2008)

Conclusions:

The test substance at a dose level of 3000 mg/kg bw, produced oedema and erythema up to day 6, but no mortality, therefore the LD0 = 3000 mg/kg bw (2700 mg/kg b.w based on active ingredient)

Executive summary:

New Zealand albino rabbits, when exposed dermally to the test substance at a dose level of 3000 mg/kg bw, corresponding to 2700 mg/kg bw based on active ingredient, produced oedema and erythema up to day 6, but no mortality. All gross necropsies were within normal limits. Within 7 days of observation period all animals were normal and remained so throughout the study.