Reaction mass of (disodium 4-[[4-(acetylmethylamino)-2-sulphonatophenyl]amino]1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and sodium sulphate and sodium chloride)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: early study, before GLP, short report, that contains the main details of the performed test, limited substance data

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

controls included, high dose and application volume

GLP compliance:

no

Remarks:

pre-dates GLP-regulation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate

EC Number:

944-710-7

Molecular formula:

not available because multi-constituent substance

IUPAC Name:

pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous gum tragacanth (0.5%)

Details on oral exposure:

prepared as a 20% suspension in aqueous gum tragacanth (0.5%) and administered by oral intubation at a dosage volume of 25 ml/kg bodyweight

Doses:

0 (control) or 5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: lethargy, piloerection, diuresis, diarrhoea and a slight increase in salivation. Blue stained urine and faeces were observed from all rats.

Gross pathology:

no relevant findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal oral dose (LDso) to rats of the test item was found to be: greater than 5000 mg/kg bodyweight.

Executive summary:

Rats of the CFY strain, in the weight range 140 to 186 g were starved overnight before treatment with the test item.

The test item was prepared as a 20% suspension in aqueous gum tragacanth (0.5%) and administered by oral intubation at a dosage volume of 25 ml/kg bodyweight.

Rats treated with the vehicle alone (25 ml/kg) served as controls.

During the observation period of 14 days, a record was kept of all signs of toxicity. All rats were sacrificed terminally and examined macroscopically in an attempt to identify any target organs.

RESULTS

Ten rats (five male and five female) were treated with the test item at a dosage level of 5000 mg/kg bodyweight .

There were no mortalities.

Signs of reaction to treatment, observed shortly after dosing, consisted of lethargy, piloerection, diuresis, diarrhoea and a slight increase in salivation. Blue stained urine and faeces were observed from all rats. Recovery of all animals, as judged by external appearance and behaviour, was apparently complete within four days of treatment.

Bodyweight gains of all rats were within normal limits and terminal autopsy findings were normal.

CONCLUSION

The acute median lethal oral dose (LD50) to rats of the test item was found to be: greater than 5000 mg/kg bodyweight.