4-Methylsulfonyl-2-nitro benzoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-01-08 to 1996-01-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-methanesulfonyl-2-nitrobenzoic acid

EC Number:

601-017-1

Cas Number:

110964-79-9

Molecular formula:

C8 H7 N1 O6 S1

IUPAC Name:

4-methanesulfonyl-2-nitrobenzoic acid

Details on test material:

- Name of test material (as cited in study report): 2-nitro-4-methylsulfonyl benzoic acid (MNBA)
- Physical state: Solid
- Analytical purity: 97 % (w/w):
- Lot/batch No.: 15483-30-1
- Storage condition of test material: Ambient temperature in darkness

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: deionised water

Controls:

no

Amount / concentration applied:

The test sample (approximately 500mg) was moistened to a dry paste with approximately 0.3ml of deionised water.

Duration of treatment / exposure:

The dressings were left in position for approximately four hours. After this the application site was gently cleansed free of any residual test sample using clean swabs of absorbent cotton wool soaked in clean warm water.

Observation period:

Degree of erythema and oedema was assessed approximately 30-60 minutes, 1, 2 and 3 days after removal of the dressings.

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: animal # 1, 2, 4 each

Time point:

other: mean of 24, 48, 72 h

Score:

0.3

Reversibility:

fully reversible within: 2 d

Results 2

Irritation parameter:

erythema score

Basis:

other: animal # 3, 5, 6 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Reversibility:

other: no signs of irritation (erythema) at any time

Results 3

Irritation parameter:

edema score

Basis:

other: animal # 1 and 2 each

Time point:

other: mean of 24, 48, 72 h

Score:

0.3

Reversibility:

fully reversible within: 2 d

Results 4

Irritation parameter:

edema score

Basis:

other: animal # 3, 4, 5, 6 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Reversibility:

other: no signs of irritation (edema) at any time

Irritant / corrosive response data:

No signs of irritation or corrosion except erythema and edema. All signs of irritaion were fully reversible within 2 d.

Other effects:

There were no signs of ill-health in any animal during the study and there were no additional signs of irritation or corrosion except erythema and edema.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

MNBA was non-irritant following a single four-hour application to rabbit skin.

Executive summary:

A group of 6 female rabbits received a single four-hour application of 2-nitro-4-methylsulfonyl benzoic acid (MNBA) to the shorn flank. The animals were assessed for 3 days for any signs of skin irritation.

Signs of very slight erythema and/or oedema were seen in three out of six animals. All signs of irritation had completely regressed in all animals 2 days after application.

MNBA was non-irritant following a single four-hour application to rabbit skin.