N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 12 October, 1993 to 3 November, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

EC Number:

201-369-2

EC Name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Cas Number:

81-68-5

Molecular formula:

C22H18N2O5S

IUPAC Name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature

Test animals

Species:

rat

Strain:

other: (Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein/Switzerland
- Weight at study initiation: 174 to 237 g
- Fasting period before study: Overnight
- Housing: Macrolon cages type 4, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: Ad libitum
- Acclimation period: At least for 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2 °C
- Humidity: 55±10 %
- Air changes: CA 15 air changes/h
- Photoperiod: 12 h dark/12 h light cycle

IN-LIFE DATES: From October 12, 1993 to November 3, 1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw (males and females)

No. of animals per sex per dose:

Five/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Clinical signs: Daily for 14 d: Body weight: Immediately before administration and on Days 7 and 14.
- Necropsy of survivors performed: Yes, at the end of the observation period.

Statistics:

The LD50 value with 95 % confidence limits were calculated, where possible.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 860 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortalities occurred in the study.

Clinical signs:

other: Piloerection, hunched posture and dyspnoea were seen within 1 h of test substance administration. The animals recovered within 5 to 6 d.

Gross pathology:

No deviations from normal morphology were found in all animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance was found to be > 2000 mg/kg bw (i.e. > 1860 mg a.i./L) in male/female rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance (of ca. 93 % purity) in Tif: RAIf (SPF) rats according to OECD Guideline 401and EU Method B.1 in compliance with GLP. A group of 10 animals (5/sex/dose) received a single oral (gavage) dose of 2000 mg/kg bw of the test substance. No mortality was observed. Normal bodyweight gains were recorded in all the animals throughout the study. Piloerection, hunched posture and dyspnoea were seen within 1 h of dosing. The animals recovered within 5-6 d. Terminal necropsy findings were normal. Based on the findings of the study, the oral LD50 of the test substance was >2000 mg/kg bw (i.e. >1860 mg a.i./L) in male/female rats.