Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-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:

1974

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:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

As per the internationally accepted guidelines

GLP compliance:

no

Remarks:

study pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

274-397-6

EC Name:

Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

70209-99-3

Molecular formula:

C23H16BrN3O9S2.2Na

IUPAC Name:

disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

FAT 40068/A

Specific details on test material used for the study:

Identified as: FAT 40068/A

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding unit, CIBA-GEIGY Limited, Basle, Switzerland
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: Overnight before the treatment
- Housing: males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5
- Diet: food (NAFAG, Gossau SG, rat food) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 + 1 °C
- Humidity (%): 50

IN-LIFE DATES: 1974

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: suspended at 30% with polyethylene glycol (PEG 400)

DOSAGE PREPARATION: Before treatment the suspension was homogeneously dispersed with an Ultra- Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

4640, 6000, 7000 and 7750 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 2 h, 24 h, 48 h, 7 days and 14 days (mortality reported)
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

7 700 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at the doses of 4640, 6000 and 7000 mg/kg bw. However 5 out of 10 animals died at the dose of 7750 mg/kg bw.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days.

Gross pathology:

No substance related gross organ changes were seen with dead and sacrificed animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 40068/A in rats of both sexes observed over a period of 14 days is approximately 7700 mg/kg bw.

Executive summary:

An acute oral toxicity study was conducted according to guideline equivalent or similar to OECD TG 401 to evaluate toxicity of REACTIVE BLUE 069. The test substance was suspended at 30 % with polyethylene glycol (PEG 400). Doses of 4640, 6000, 7000 and 7750 mg/kg bw were administered to rats divided in four groups each containing 5 males and 5 females. The treated animals were observed for 14 days for clinical signs and mortality. No mortality was observed at the doses of 4640, 6000 and 7000 mg/kg bw. However 5 out of 10 animals died at the dose of 7750 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. No substance related gross organ changes were seen at post mortem examinations. Based on the findings of the study, the acute oral LD50 of FAT 40068/A in rats of both sexes observed over a period of 14 days is approximately 7700 mg/kg bw.