Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

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

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

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:

GHS criteria not met

Conclusions:

No mortality occured among male and female rats in an OECD 402 limit test. The LD50 (rat) is > 2000 mg/kg bw.