2-phenyl-1H-benzimidazole-5-sulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

study was performed prior to OECD guideline availability but followed in principle the method as described there. The toxicity of the test material after oral administration was studies in Wistar rats. A 16.5% solution of the test item was administered orally (gavage) to 10 animals at a volume of 40 mL/kg body weight (bw) resulting in a dose of 6600 mg/kg. After an observation period of 14 days the animals were killed and investigated for macroscopic signs of pathological changes.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-phenyl-1H-benzimidazole-5-sulphonic acid

EC Number:

248-502-0

EC Name:

2-phenyl-1H-benzimidazole-5-sulphonic acid

Cas Number:

27503-81-7

Molecular formula:

C13H10N2O3S

IUPAC Name:

2-phenyl-1H-benzimidazole-5-sulphonic acid

Test animals

Species:

other: mouse and rat

Strain:

other: mouse--CF-1; rat--Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Experimental animals and housing conditions
Animals employed in this study were male SPF-bred mice of the strain CF1 with a mean weight of about 20 g and male SPF-bred Wistar rats with a mean weight of 220 g.
The mice had been supplied by Winkelmann - Kirchborchen, the rats by Mus Rattus AG, Brunnthal near Munich. Mice and rats were housed in groups of 5 animals each in Makrolon Type I and Type III cages, respectively, at a room temperature of about 22 °C and natural light.They received pellets of dry feed (supplier, Altromin GmbH, Lage/Lippe) and water ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Test article-Na solution was administered in its present form as a 16.5% concentration with an application volume of 40 ml/kg body weight, which is, for technical reasons, the maximum volume to be applied. Administration to mice and rats was performed using a gavage. Prior to application the animals were kept non-fasted.

Doses:

6600 mg were administered as a 16,5% Novantisol-Na solution at a volume of 40 ml/kg body weight.

No. of animals per sex per dose:

10 mice; 10 rats

Control animals:

not specified

Details on study design:

Signs and deaths occurring during a 14-day observation period were recorded in the study records. After the observation period the animals were sacrificed and necropsied.

Statistics:

Calculation of the LD50 on the confidence level of p=0.5 is usually performed with the program-controlled probit analysis according to FINK and HUND.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 6 600 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 6,600 mg test article-Na was tolerated by the animals investigated without signs.

Mortality:

No mortality was observed throughout the observation period (14 days).

Clinical signs:

other: Acute toxicity of test article-Na in mice after oral administration: 6,600 mg test article-Na was tolerated by the mice investigated without signs. As the 6,600 mg were administered as a 16.5 % Test article-Na solution at a volume of 40 ml/kg body weight

Gross pathology:

Necropsy of the mice sacrificed after a 14-day observation period gave no indication of macroscopically noticeable pathological changes.
Neither did necropsies of rats after 14 days of observation give any indication of pathological organ changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (oral, rat/mouse): >6600 mg/kg body weight

Executive summary:

This acute toxicity of test article was performed with mice and rats at a single concentration of 6600 mg/kg body weight by oral gavage. As the 6,600 mg were administered as a 16.5 % Test article-Na solution at a volume of 40 ml/kg body weight and administration of a higher dose was not possible for technical reasons, no lethal dose could be established. Necropsy of the animals sacrificed after a 14-day observation period gave no indication of macroscopically noticeable pathological changes.

In conclusion, LD50 of sodium salt of test article is considered to be greater than 6600 mg/kg body weight.