Sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Jul - 01 Aug 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate

EC Number:

267-990-6

EC Name:

Sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate

Cas Number:

67969-88-4

Molecular formula:

C27H20N2O8S2.Na

IUPAC Name:

sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: male: mean 216 g (212 - 220 g); female: 171 (169 - 174 g)
- Housing: transparent Macrolon cages on soft wood granulate in air-conditioned room
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70% rh
- Photoperiod (hrs dark / hrs light): 12:12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: water soluble substance

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: highest dose is cut-off value (limit design) for classification

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day (weekends: once a day)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

Squatting posture, stilted gait, irregular respiration, discoloured faeces. No symptoms from day 3 onward.

Body weight:

Development of body weight not impaired.

Gross pathology:

No macroscopically visible changes observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item has a LD50 > 2000 mg/kg determined an acute toxicity study with female and male rats. The classification criteria are not met.