Sodium 2-[[4-[3-(4,5-dichloro-2-methylphenyl)-4,5-dihydro-1H-pyrazol-1-yl]phenyl]sulphonyl]ethanesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

weight of evidence

Study period:

June from 11 to 25, 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 12 May 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund.

Test system

Amount / concentration applied:

100 mg per eye

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 animals

Details on study design:

SCORING SYSTEM
Draize test system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 2/3

Time point:

24/48/72 h

Score:

2.3 - 2.7

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 2/3

Time point:

24/48/72 h

Score:

< 2

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

On the basis of the numerically evaluated individual findings at observation times after 24, 48 and 72 hours, the following mean values were calculated:
animal 58: corneal opacity 0, iris 0.3, conjuntival redness 2.3, conjunctival chemosis 2.0
animal 78: corneal opacity 0, iris 0, conjuntival redness 1.3, conjunctival chemosis 0.3
animal 80: corneal opacity 0, iris 0, conjuntival redness 2.7, conjunctival chemosis 1.0

Applicant's summary and conclusion

Conclusions:

Weakly irritating

Executive summary:

The primary eye irritation potential of test item was investigated by the application of 100 mg of test item to three New Zealand White rabbits. The method and procedures followed were in accordance with those outlined into the OECD guideline 405 and EU method B5. The scoring of eye reactions was performed 1, 24, 48 and 72 hours after removal of the dressing, according to the Draize system.

On the basis of the numerically evaluated individual findings at observation times after 24, 48 and 72 hours, the following mean values were calculated: animal 58 corneal opacity 0, iris 0.3, conjuntival redness 2.3, conjunctival chemosis 2.0; animal 78 corneal opacity 0, iris 0, conjuntival redness 1.3, conjunctival chemosis 0.3; animal 80 corneal opacity 0, iris 0, conjuntival redness 2.7, conjunctival chemosis 1.0.

The substance resulted to be weakly irritating.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for conjunctival oedema, in two out of three tested animals; the value for conjuntival redness resulted to be higher than 2 in two out of three animals.

Therefore, the substance meets the criteria to be classified as eye irritating, category 2 (H319), according to the CLP Regulation (EC) No 1272/2008.