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)

Endpoint summary

Description of key information

Only slight transient effects were recorded after a single oral dose of 5000 mg/kg bw in rats

no mortality at 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Species:

rat

Strain:

other: CFY

Sex:

male/female

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

2 valid with restrictions

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Only slight transient effects were recorded after a single oral dose of 5000 mg/kg bw in rats

Justification for selection of acute toxicity – oral endpoint
only available study

Justification for classification or non-classification

no classification

no mortality at 5000 mg/kg bw.