4-mesyl-2-nitrotoluene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 September - 28 September 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-550-0

EC Name:

-

Cas Number:

1671-49-4

Molecular formula:

C8H9NO4S

IUPAC Name:

4-methanesulfonyl-1-methyl-2-nitrobenzene

Details on test material:

- Physical state: white powdery solid
- Storage condition of test material: ambient temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: 2414-3283 g
- Housing: individually, in cages suitable for rabbits of this strain and weight range expected during the course of the study
- Diet: STANRAB SQC ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17±2°C
- Humidity: 40-70%
- Air changes: approximately 25 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 13 September 1995 To: 28 September 1995

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Remarks:

corn oil

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 500 mg
- The test substance was moistened to a dry paste with approximately 0.5 mL corn oil

VEHICLE
- Amount(s) applied (volume or weight with unit): the test substance was moistened with approximately 0.5 mL corn oil to a dry paste

Duration of treatment / exposure:

4 hours

Observation period:

4 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm of the left flank
- % coverage: not reported
- Type of wrap if used: the treated area was covered with a piece of 8-ply surgical gauze which was secured by two strips of surgical tape. This was covered by a piece of impermeable rubber sheeting wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application site was cleansed free of any residual test material using clean swabs of absorbent cotton wool and clean warm water, then dried with clean tissue paper.
- Time after start of exposure: approximately 4 hours

SCORING SYSTEM
- The Draize scale (Draize JH (1959) Third printing, 1975. 'Dermal Toxicity' in 'Appraisal of the safety of chemicals in food, drugs and cosmetics'. Association of Food and Drug Officials of the US, pp46-59) was used to assess the degree of erythema and oedema approximately 30 minutes and 1, 2, 3 and (for one animal) 4 days after removal of the dressings. Any other signs of skin irritation were also noted.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: 30 minutes after decontamination

Score:

1

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

no changes at any timepoint

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 30 minutes after decontamination

Score:

1

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

no changes at any timepoint

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

no changes at any timepoint

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Any other information on results incl. tables

Table1: Individual and mean skin irritation scores according to the Draize scheme

Time	Erythema			Oedema
Animal number	2	10	11	2	10	11
after 1 hour	1	1	1	1	1	1
after 24 hours	1	0	1	0	0	1
after 48 hours	1	0	1	0	0	0
after 72 hours	1	0	0	0	0	0
mean score 24-72 hours	1	0	0.7	0	0	0.3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

This test substance is a slight irritant following a single four-hour application to rabbit skin. The substance does not meet the criteria for classification.

Executive summary:

A group of 3 female rabbits received a single four-hour application of 500 mg of the test substance to the shorn flank. The animals were assessed for up to 4 days for any signs of skin irritation.

Very slight erythema was seen in all three animals approximately 1 hour after decontamination and in two animals for the following 2 or 3 days. Very slight oedema was seen in all three animals approximately 1 hour after decontamination and in one animal for 1 day. All signs of irritation had completely resolved 4 days after application.

The test substance is a slight irritant following a single four-hour application to rabbit skin.