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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug 10 - 17, 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 38 to 41 weeks
- Weight at study initiation: 4,05 (3,30 - 4,56) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm^2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20 °C
- Humidity (%): 53 to 89 %

IN-LIFE DATES: From: day 1 To: day 8

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 mL of undiluted or diluted (16 % aqueous solution) test item was applied

Duration of treatment / exposure:

4 h

Observation period:

8 days

Number of animals:

6 (3m, 3f)

Details on study design:

TEST SITE
- Area of exposure: 4 cm2
- % coverage: 100 %
- Type of wrap if used: polyethylene foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible

Remarks:

after 5 days

Remarks on result:

other: with undiluted test item

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: with undiluted test item

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: with diluted test item

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: with diluted test item

Other effects:

No signs of systemic toxicity were detected. The body weight development was not different from that of untreated rabbits of the same age. All animals survived the 8-day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the test material is evaluated as not irritating to the skin.

Executive summary:

The test material was tested for primary skin irritation in New Zealand White rabbits (Iva: NZW) in a GLP Study according to test guideline OECD 404. The test item was tested undiluted and as a 16 % aqueous solution. Six animals (3 males and 3 females) were used for this study. Aliquots of 0.5 mL of either the undiluted or diluted test item were given onto 4 cm2 patches and applied onto the left side of the shaved backs of each animal. The diluted test item was applied to the right side of each animal. The patches were wrapped by polyethylene foil under occlusive conditions. After 4 hours of occlusive exposure the patches were removed and any test item left was wiped off. The animals were investigated for skin alterations, clinivcal symptoms and body weight for a period of 8 days. Skin changes at the application sites were evaluated according to Draize (1959). The application of the undiluted test item to the intact dorsal skin of rabbits for 4 hours under occlusive conditions resulted in very slight skin irritation: The 24/48/72 hours values for erythema in the 6 animals were 0.0 in 5 animals and 1.0 in one animal (mean 0.17). The effects observed in the one animal were reversible and vanished on day 5. The 24/48/72 hours mean value for edema were 0.0 in all animals. Treatment with the 16 % aqueous solution of the test item did not result in any effect, i.e. the 24/48/72 mean values for erythema and edema in all 6 animals were 0.0. Based on the results of this study, the test material is evaluated as not irritating to the skin.