Sodium sulphanilate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 12 April 1995 to 27 April 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline and EU method. GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium sulphanilate

EC Number:

208-208-5

EC Name:

Sodium sulphanilate

Cas Number:

515-74-2

Molecular formula:

C6H7NO3S.Na

IUPAC Name:

sodium 4-aminobenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: white powder
- Analytical purity: 91.5%
- Lot/batch No.: 868 TO
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan- Winkelmann GmbH, Borchen
- Age at study initiation: males: approximately 6-7 weeks old; females: approximately 8-9 weeks old
- Weight at study initiation: males: 175-188 g; females: 148-159 g
- Fasting period before study: 16 hours
- Diet (e.g. ad libitum): Altromin 1324 Pellets, ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 5%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The evaluation of general condition of the animals was conducted twice a day. The animals’ body weight was determined individually directly before the administration of the test item and then on the 7th and 14th day.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

The animal necropsy did not reveal any pathological changes.

Any other information on results incl. tables

Table 1:    Summary of acute oral toxicity

 

Dose	Females	Males
	Mortality	Mortality
2000 mg/kg bw	0/5	0/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for the test substance was greater than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity study was performed according to the OECD Guideline No. 401 and EU Method B.1. A single dose of 2000 mg/kg b.w was administered to five animals per sex. After the administration of the test item, the animals were observed for 14 days. General and detailed clinical observations were conducted and body weights were determined individually before the administration of the test item as well as on the 7th and 14th day. After the 14-day observation period, all animals were euthanized and subjected to a necropsy and a detailed gross examination. All animals survived the observation period. Body weight gains were observed in all animals. The animal necropsy did not reveal any pathological changes. The oral LD50 for the test substance was greater than 2000 mg/kg bw.