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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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:
Piloerection, hunched posture and dyspnoea were seen within 1 h of test substance administration. The animals recovered within 5 to 6 d.
Body weight:
Normal body weight gains were recorded in all the animals.
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.