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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1974

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:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

occlusive patch was used

GLP compliance:

no

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: EMD SPF
- Weight at study initiation: 148 (121 - 176) g
- Housing: separately in Macrolon Type III cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 26 °C
- Humidity (%): 42 - 47 %

IN-LIFE DATES: From: day 1 To: day 14

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10
- Type of wrap if used: tin foil fixed and sealed with rubber sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL / 100 g bw
- Concentration (if solution): 30 % in water
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

3000 mg/kg bw

No. of animals per sex per dose:

10 (5m, 5f)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 2 weeks
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

no statistics

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed. All animals survived the observation period (14 days).

Clinical signs:

other: On the day of treatment the mobility and well-being of the rats were necessarily limited by the rubber sleeve applied. After 24 hours all rats were free from symptoms. No local effects were observed at the treated skin sites.

Gross pathology:

No pathologicol-anatomical changes were observed in any of the rats.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study the dermal LD50 of Phenylbenzimidazole sulfonic acid (Na-salt) in rats is > 3.000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test material was investigated in Wistar-AF rats.

A 30 % aqueous solution of the test item corresponding to a dose of 3000 mg/kg bw was applied on the shaved skin of 5 male and 5 female rats for 24 hours under occlusive conditions (tin foil fixed and sealed with rubber sleeve). After 24 hours the tin foil was removed and residual test item was washed off with water. The rats were observed and weighed daily for 14 days.

Changes at the application site were rated according to Draize (FDA Appraisal, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics by FDA, Baltimore Md. 1959, page 51).

No mortalities were observed during the observation period of 14 days. No local effects were observed at the treated skin sites. At necropsy no pathological changes were observed in any of the rats.

Based on the results of this study the dermal LD50 of Phenylbenzimidazole sulfonic acid (Na-salt) in rats is > 3.000 mg/kg bw.