Sulphamidic acid

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1942

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Although the study report in a peer-reviewed journal fulfilled scientific principles, some deviations (as expected) from OECD guideline developed 40 years later are apparent, mainly consisting of lack of experimental details.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Studies on the Physiological Effects of Sulfamic Acid and Ammonium Sulfamate

Author:

A.M. Ambrose

Year:

1943

Bibliographic source:

The Journal of industrial hygiene and toxicology 25:26-28

Report date:

1942

Materials and methods

Principles of method if other than guideline:

4 doses (0.1, 0.2, 0.4 and 0.8 g/kg bw sulfamic acid) were tested for acute oral toxicity by intraperitonal injection. Representative numbers of animals were used per dose group. Sulfamic acid was applied as 4% aqueous solution having a pH of 0.82, measured electrometrically.

GLP compliance:

no

Remarks:

pre-dates GLP requirements

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sulphamidic acid

EC Number:

226-218-8

EC Name:

Sulphamidic acid

Cas Number:

5329-14-6

Molecular formula:

H3NO3S

IUPAC Name:

sulfamic acid

Test material form:

solid: particulate/powder

Details on test material:

sulphamidic acid

Test animals

Species:

rat

Strain:

other: reported as white rat, no strain details provided

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Remarks:

4% aqueous solution, pH 0.82

Details on exposure:

Male white rats weighing 80 - 100 grams were used

Doses:

0.1, 0.2, 0.4 and 0.8 g sulfamic acid/kg bw

No. of animals per sex per dose:

5 animals per dose group

Control animals:

no

Details on study design:

All doses were administered in terms of sulfamic acid per kilogram of body weight

Statistics:

no statistics applied

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

< 100 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was observed in all dose groups applied being greater 50%.
100 mg/kg bw: 4/5 dead
200 mg/kg bw: 5/5 dead
400 mg/kg bw: 3/5 dead
800 mg/kg bw: 5/5 dead

Clinical signs:

The author states "Sulfamic acid after intraperitoneal injection produced no toxic symptoms, although death occured on all dose levels 4 to 72 hours after adminstration."

Body weight:

80 - 100 gram per rat, no effects on body weight development were reported

Gross pathology:

not performed in the acute study but in a chronic study, also reported in the article, histopathological examination failed to reveal and changes that could be ascribed to sulfamic acid exposure.

Applicant's summary and conclusion

Conclusions:

Sulfamic acid showed high systemic toxicity when applied intraperitoneal. When comparing to the effects seen in the oral study, described in the publication, the mortality seen in the i.p. study may be attributable to the very low pH (0.82) of the 4% aqueous solution injected.

Executive summary:

In this published study acute intraperitoneal toxicity to rats was investigated up to a maximum dose of 800 mg/kg bw. Mortality > 50% occured at all doses (100, 200, 400 and 800 mg/kg bw). The animals produced no toxic symptoms, although death occured at all dose groups after 4 - 72 hours of exposure (i.p.). Therefore, no LD50 was reported. When comparing to the effects seen in the oral study, described in the same publication, the mortality seen in the i.p. study may be attributable to the very low pH (0.82) of the 4% aqueous solution injected. This is also supported by findings when ammonium sulfamate was applied (reported in the same study) which in 4% aqueous solution has a pH of 4.82 and only caused mortality at 800 mg/kg bw (6 out of 10 animals) when applied by intraperitoneal injection (no mortality at 100, 200 and 400 mg/kg bw).