Sodium dimethyl 5-sulphonatoisophthalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-05-29 to 2012-06-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

In vivo eye irritation study was initiated before the entry into force of the amendments to Annexes VII and VIII

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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 OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dimethyl 5-sulphonatoisophthalate

EC Number:

223-578-8

EC Name:

Sodium dimethyl 5-sulphonatoisophthalate

Cas Number:

3965-55-7

Molecular formula:

C10H10O7S.Na

IUPAC Name:

sodium 3,5-bis(methoxycarbonyl)benzenesulfonate

Test material form:

other: solid

Details on test material:

Name: Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: S & K LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: Young adult rabbits
- Weight at study initiation: 2838-3213 g
- Housing: Animals were housed individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 9-12 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, from 6 a.m. to 6 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

The test item was ground to a fine dust prior to application

Controls:

other: The contralateral eye served as control

Amount / concentration applied:

A weight of 0.1 g of the undiluted ground test item Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester) was used for the study in pure state, in a single dose.

Duration of treatment / exposure:

Continuous (the eyes of the test animals were not washed out after the application of test item).

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hour(s) and then at 1 week after the application.

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

SCORING SYSTEM: according to the scoring system by Draize (1979) and OECD 405 (24 April 2002)

BODY WEIGHT: The body weights were recorded at the beginning and at the end of the experiment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 1 week

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 1 week

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 1 week

Irritant / corrosive response data:

- The animals individual mean score (considering reading at 24,48 and 72 hours after the treatment) for discharge was: 0.33, 0.00 and 2.67. However, conjunctival discharge does not represent a relevant endpoint with respect to classification for acute eye irritation.

- During the study the control eyes of the animals were symptom-free.

Other effects:

General state and the behaviour of the animals were normal throughout the study period. There were no effects on body weight attributable to the treatment with the test item during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item, caused slight to moderate conjunctival irritant effects, fully reversible within 1 week and not relevant for C&L. There were no test item-related effects on cornea and iris.

Executive summary:

In an acute eye irritation study (Toxicoop Zrt., 2012, OECD 405, GLP compliance) three rabbits were exposed with the test item Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A weight of 0.1 g of the ground test item was used in pure state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48 and 72 hour(s) and then at 1 week after the application. One hour after the treatment, slight conjunctival redness and chemosis, as well as slight to moderate discharge were observed. 24 hours after the treatment, slight redness, slight to moderate chemosis, as well as slight and severe discharge were detected in two animals. 1 week after treatment the study was terminated, as all animals were free of symptoms of irritation. There were no test item-related effects on cornea and iris. In conclusion the test item SIM-Ester did not show any irritating effects relevant for C&L.