Disodium oxybis[methylbenzenesulphonate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Disodium oxybis[methylbenzenesulphonate]

EC Number:

277-242-0

EC Name:

Disodium oxybis[methylbenzenesulphonate]

Cas Number:

73037-34-0

Molecular formula:

C14H12Na2O7S2

IUPAC Name:

disodium oxybis(methylbenzenesulfonate)

Test material form:

solid

Details on test material:

Active content reported: 90-95 %

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: animal 1: 19 weeks, animal 2: 34 weeks, animal 3: 30-31 weeks
- Weight at study initiation: > 2 kg
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye of each animal served as control.

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

once

Observation period (in vivo):

up to 6 days

Number of animals or in vitro replicates:

3 females

Details on study design:

The test item was applied at a single dose (100 mg) into the conjunctival sac of one eye of each test animal after pulling the lower lid away from eyeball. The lids were then gently held together for about 1 sec in order to prevent loss of the material. The untreated contralateral eye served as control. The treated eye was not rinsed. The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored according to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: up to 72 hours

Score:

ca. 0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: up to 72 hours

Score:

ca. 0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: up to 72 hours

Score:

>= 0.67 - <= 1

Max. score:

3

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: animal 1: score 1 of max 3 for 72 h; animal 2: score 1 for 48 h: amimal 3: score 1 for 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: up to 72 hours

Score:

ca. 0

Max. score:

4

Irritant / corrosive response data:

The only effects observed: Some blood vessels were hyperaemic (conjunctival injections, score 1 of max 3), which was fully reversible within 6 days.

Other effects:

no effects reported

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

The animals showed slightly irritation effects which were fully reversible within 6 days and which do no lead to classification.

Executive summary:

Ditolylether disulfonic acid disodium salt, isomer mixture was tested for eye irritating property using 3 female New Zealand White rabbits. The test item was applied at a single dose (100 mg, undissolved) into the conjunctival sac of one eye of each test animal after pulling the lower lid away from eyeball. The lids were then gently held together for about 1 sec in order to prevent loss of the material. The untreated contralateral eye served as control. The treated eye was not rinsed. The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored according to Draize. The animals showed slightly irritation effects (conjunctival injections) most probabely due to mechanical irritation by the undissolbed substance. These effects were fully reversible within 6 days and do no lead to classification.