4-mesyl-2-nitrotoluene

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: 2553-3045 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: 40-81%
- Air changes: approximately 25-30 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Approximately 100 mg

Duration of treatment / exposure:

Single dose

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not washed.

SCORING SYSTEM: an assessment of initial pain was made using a six-point scale. 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 grade of ocular reaction approximately one hour and 1, 2, 3 and (for one animal) 4 days after application.

TOOL USED TO ASSESS SCORE: fluorescein staining was used at all readings from day 1 after application.

A modified form of the Kay and Calandra system (Kay JH and Calandra JC 1962, Interpretation of eye irritation tests. J Soc Cosmet Chem 13, pp281-289) was used to interpret and classify the numerical scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: initial pain

Basis:

mean

Time point:

other: immediately after application

Remarks on result:

other: none or slight initial pain (class 0-2 on a 0-5 scale)

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1.2 hrs, 1, 2, 3 and (for one animal) 4 days

Score:

0

Max. score:

80

Remarks on result:

other: no corneal effects in any animal

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1.2 hrs, 1, 2, 3 and (for one animal) 4 days

Score:

0

Max. score:

10

Remarks on result:

other: no effects in the iris in any animal

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1.2 hrs

Score:

9.3

Max. score:

20

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: day 1

Score:

2

Max. score:

20

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: day 2

Score:

2

Max. score:

20

Reversibility:

fully reversible within: 3 days

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal: #15

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

no change at any timepoint

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal: #12

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

no change at any timepoint

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal: #13

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

No change at any timepoint

Results 10

Irritation parameter:

iris score

Basis:

animal: #15

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

no change at any timepoint

Results 11

Irritation parameter:

iris score

Basis:

animal: #12

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

No change at any timepoint

Results 12

Irritation parameter:

iris score

Basis:

animal: #13

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

No change at any timepoint

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal: #15

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 hours

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal: #12

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 hours

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal: #13

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 hours

Results 16

Irritation parameter:

chemosis score

Basis:

animal: #15

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

No change at any timepoint

Results 17

Irritation parameter:

chemosis score

Basis:

animal: #12

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

No change at any timepoint

Results 18

Irritation parameter:

chemosis score

Basis:

animal: #13

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks:

No change at any timepoint

Any other information on results incl. tables

Approximately 1/3 or 1/2 of the test substance was displaced from the conjunctival sac of two animals immediately after application.

Application into the eye caused no or slight pain (class 0 -2 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects, in all animals for up to 2 days, consisted of slight or moderate redness, slight or mild chemosis and a slight or moderate discharge. In addition, two animals had a slight mucoid discharge. All signs of irritation had completely resolved 3 days after application.

Eye irritation scores of according to the Draize scheme

Time		Cornea			Iris			Conjunctiva
								Redness			Chemosis
Animal number		15	12	13	15	12	13	15	12	13	15	12	13
after 1 hour		0	0	0	0	0	0	2	1	2	1	1	2
after 24 hours		0	0	0	0	0	0	1	1	1	0	0	0
after 48 hours		0	0	0	0	0	0	1	1	1	0	0	0
after 72 hours		0	0	0	0	0	0	0	0	0	0	0	0
mean scores 24-72 hours		0	0	0	0	0	0	0.7	0.7	0.7	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is a mild irritant (class 4 on a 1-8 scale) to the rabbit eye. The substance does not meet the criteria for classification.

Executive summary:

The test substance (100 mg) was applied into one eye of each of three rabbits and an assessment of initial pain was made. The eyes were examined for up to 4 days, to assess the grade of ocular reaction.

Application into the eye caused no or slight pain (class 0 -2 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects were seen in all animals for up to 2 days. All signs of irritation had completely resolved 3 days after application.

The test substance is a mild irritant (class 4 on a 1-8 scale) to the rabbit eye.