Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer-reviewed journal

Data source

Reference

Reference Type:

publication

Title:

A Pharmacological Study of Sodium Alkyl a Homologous Sulfates

Author:

LAURENCE E. GALES and PAUL M. SCOTT

Year:

1953

Bibliographic source:

Journal of the American Pharmaceutical Association, Scientific Edition. Vol. 42, Pg. 283, 1953

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute oral toxicity study of Sodium octyl sulfate in rats

GLP compliance:

not specified

Test type:

other: no data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium octyl sulphate

EC Number:

205-535-5

EC Name:

Sodium octyl sulphate

Cas Number:

142-31-4

IUPAC Name:

sodium octyl sulfate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report):Sodium octyl sulfate - Molecular formula (if other than submission substance):C8H18O4S.Na- Molecular weight (if other than submission substance):232.274 g/mole - Substance type:Organic - Physical state:Crystals (Solid)

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: No data available - Age at study initiation: No data available- Weight at study initiation: No data available - Fasting period before study: No data available - Housing: No data available - Diet (e.g. ad libitum): Rat pellets experimental diet. - Water (e.g. ad libitum): No data available - Acclimation period: No data available ENVIRONMENTAL CONDITIONS- Temperature (°C): 21.11 °C- Humidity (%): Constant - Air changes (per hr): No data available - Photoperiod (hrs dark / hrs light): No data available IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Distilled

Details on oral exposure:

VEHICLE- Concentration in vehicle: 3200 mg/kg bw - Amount of vehicle (if gavage): 1 cc / 100 g bw- Justification for choice of vehicle: No data available- Lot/batch no. (if required): No data available- Purity: No data available MAXIMUM DOSE VOLUME APPLIED: No data available DOSAGE PREPARATION (if unusual): A dosage schedule was established whereby each group of five animals was given a dosage which differed by 0.5 g/Kg. from each preceding or succeeding dosage. The compounds were administered as aqueous mixtures prepared in such a manner that 1 cc. of detergent preparation was administered for each 100 g. of rat. The mixtures administered were warmed to 350. However, the viscosity of the mixtures of tetradecyl, hexadecyl, and octadecyl compounds at dosages greater than 3.5 g/Kg. for the first preparation and 3.0 g/Kg. for the latter two preparations was so high that the mixtures could not be forced through an oral needle.CLASS METHOD (if applicable)- Rationale for the selection of the starting dose: No data available

Doses:

3200 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 24 hours - Frequency of observations and weighing: No data available - Necropsy of survivors performed: yes- Other examinations performed: clinical signs, gross pathology and histopathology were examined.

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50 % mortality observed

Mortality:

50 % mortality was observed in treated rats as compared to control.

Clinical signs:

other: Depression, severe diarrhea which was characterized by the presence of Blood was observed in treated rats as compared to control.

Gross pathology:

Varying stages of acute gastritis and congestion of the mucosa of small intestine, stomach contained some food, swollen and severely ulcerated was observed in treated rats as compared to control.

Other findings:

Histopathology: Presence of crenated and ruptured red blood cells along with accumulations of cells from the gastric mucosa was observed in treated rats as compared to control.

Any other information on results incl. tables

Oral Ld50 Results for the Sodium alkyl sulpates determined for Rats

Sodium alkyl sulpates	Oral Administration
Octyl	pH of solution	LD50 for rats Gm./Kg
	6.8	3.20

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

LD50 was considered to be 3200 mg/kg bw when rats was treated with Sodium octyl sulfate orally by gavage in distilled water.

Executive summary:

In a acute oral toxicity study,rats was treated withSodium octyl sulfate in the concentration of 3200 mg/kg bw orally by gavage in distilled water. 50 % mortality and Depression, severe diarrhea which was characterized by the presence of Blood was observed in treated rats as compared to control. In addition, Varying stages of acute gastritis and congestion of the mucosa of small intestine, stomach contained some food, swollen and severely ulcerated and Presence of crenated and ruptured red blood cells along with accumulations of cells from the gastric mucosa was observed in treated rats as compared to control. Therefore,LD50 was considered to be 3200 mg/kg bw when rats was treated withSodium octyl sulfate orally by gavage in distilled water.