2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

84/449/EWG, B.3; OECD 402

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate

EC Number:

240-267-2

EC Name:

Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate

Cas Number:

16102-99-1

Molecular formula:

C22H18N2O11S3.2Na C22H16N2Na2O11S3

IUPAC Name:

disodium 1-amino-9,10-dioxo-4-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

see below

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 178 g; females: 184 g
- Fasting period before study: NA
- Housing: single
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25.11.1987 To: 9.12.1987

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Remarks:

0.9% NaCl solution in the proportion of 1 g + 1 ml to form a paste

Details on dermal exposure:

Area: 30 cm²

Duration of exposure:

24 h

Doses:

2000 mg/kg BW

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signsand mortality: frequently first day; twice daily thereafter
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: no sytemic clinical signs were observed

Gross pathology:

No effects observed

Other findings:

Blue or red to purple discolored skin up to 6 days after test substance application

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute dermal LD50 male/female is greater than 2000 mg/kg.

Executive summary:

Die Prüfung der akuten dermalen Toxizität von Reaktiv Blau F-64 357 FW an der Wistar-Ratte ergab bei männlichen und weiblichen Tieren eine Dosis letalis media (LD50) über 2000 mg/kg Körpergewicht. Nach Applikation von 2000 mg/kg Kgw. traten

keine Todesfälle auf.

Während der gesamten Versuchszeit traten keinerlei Vergiftungssymptome auf. Die behandelte Hautfläche war bis zum 6. Tag p.a. blau bzw. rot bis lila verfärbt.

Die Sektion der nach Versuchsende getöteten Tiere ergab keine makroskopisch sichtbaren Besonderheiten.

Die Körpergewichtsentwicklung war nicht beeinträchtigt.

Aufgrund der akuten dermalen Toxizitätsprüfung an der männlichen und weiblichen Wistar-Ratte ist Reaktiv Blau F-64 357 FW nach den Einstufungskriterien der Richtlinie 83/467/EWG und der Gefahrstoffverordnung nicht kennzeichnungspflichtig.