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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 28 July, 1993 to 11 August, 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)
Version / remarks:
Adopted February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
December, 1992
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-anilino-3-nitro-N-phenylbenzenesulphonamide
EC Number:
225-862-7
EC Name:
4-anilino-3-nitro-N-phenylbenzenesulphonamide
Cas Number:
5124-25-4
Molecular formula:
C18H15N3O4S
IUPAC Name:
4-anilino-3-nitro-N-phenylbenzenesulfonamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Terasil gelb GWL roh feucht (FAT 36014/F)
- Substance type: Dye
- Physical state: Yellow-brown powder
- Analytical purity: 90.7%
- Lot/batch No.: 292347.26
- Expiration date of the lot/batch: April 01, 1998
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
-Stability in vehicle: Stability in carboxymethyl cellulose 1% not indicated
-Test substance No.:32625
Specific details on test material used for the study:
TEerasil Yellow GWL crude moist (FAT 36'014/F)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: Approx. 10 weeks
- Weight at study initiation: Males : 231 - 268 g; Females: 168 - 192 g
- Fasting period before study: 16 to 22 h (access to water was not interrupted). Food was presented approx. 3 to 4 h after dosing
- Housing: Group housing of 5 animals/sex/cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands)
- Diet: Standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle Ag, Kaiseraugst, Switzerland) (free access, except for overnight fasting period)
- Water: Tap-water (Free access)
- Acclimation period: At least one week
- Identification: By individual earmark.
- Randomisation: Randomly selected at time of delivery in groups of five.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: 15 air changes/h
- Photoperiod: 12 h/12 h (music during light period)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1%
Details on oral exposure:
Test substance preparation:
The test substance was placed into a glass beaker on a tared Mettler analytical balance and carboxymethyl cellulose 1 % was added. A weight/weight suspension was prepared using a magnetic stirrer, a mechanical stirrer and an electric blender. The preparation was made immediately prior to each dosing.
Dose volume: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 d
Other examinations performed: clinical signs, body weight,
- Mortality / Viability: At least three times each Day.
- Body Weights: Test Days 1 (pre-administration), 8 and 15
- Clinical Signs: Each animal was examined for changes to treatment with particular attention paid to changes in behaviour, respiration, motility, body posture, motor susceptibility, skin, eyes, nose and fur. Observations were performed four times during Day 1, and once daily during Days 2 - 15. All abnormalities were recorded.
- Necropsy of survivors performed: yes; all animals were necropsied. All animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide asphyxiation.
Statistics:
No data

Results and discussion

Effect levelsopen allclose all
Key result
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:
> 1 814 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of ill health or behavioural changes were observed during the study period.
Body weight:
Normal body weight gain was noted in all females over the first week of the study and in all males over the whole study period. However, slightly reduced body weight gain was noted in all females over the second week of the study period compared to Week 1.
Gross pathology:
Macroscopic post mortem examination of the animals at termination did not reveal any significant abnormalities. Renal pelvic dilation, observed in 1/10 treated animals, is a common finding in animals of this age and strain and therefore considered of no toxicological significance.

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. ca. >1814 mg a.i./kg bw) in rats.
Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance (of 90.7 % purity) in Wistar rats according to OECD Guideline 401 and EU Method B.1 in compliance with GLP. A group of 5 female and 5 male rats received a single oral (gavage) dose of 2000 mg/kg bw of test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals over a 15 d observation period. No mortality and no clinical signs were observed and no significant macroscopic abnormalities were seen at necropsy except renal pelvic dilation, observed in a single male, which is a common finding in animals of this age and strain and was therefore considered to be of no toxicological significance. Further, normal body weight gain was noted in all females over the first week. However, slightly reduced body weight gain was observed among females over Week 2 compared to Week 1. Taking the above findings into account, the oral LD50 of the test substance was >2000 mg/kg bw (i.e. ca. >1814 mg a.i./kg bw) in rats.