Trimethyloxosulphonium iodide

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: Well documented study according to international accepted guidelines and GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trimethyloxosulphonium iodide

EC Number:

217-204-2

EC Name:

Trimethyloxosulphonium iodide

Cas Number:

1774-47-6

Molecular formula:

C3H9OS.I

IUPAC Name:

trimethyl(oxo)-λ⁶-sulfanylium iodide

Test material form:

solid: crystalline

Details on test material:

Test item: Trimethylsulfoxonium Iodide (CAS 1774-47-6)
Batch No.: 20130228 (0056D53)
Physical state: solid, crystalline powder
Colour: white or light-yellow
Content (Chemical Titration): 99.66 %
Storage: on cool and dry place, protected from light

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species and strain: New Zealand white rabbit
Source: S & K-LAP Kft.
Number of animal: 3 males
Age of animals: adult rabbits, 17 weeks old
Hygienic level during the study: good conventional
Animal health: Only animals in acceptable health condition were used for the test.
Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system
The environmental parameters were recorded daily during the study.
Before housing the animals the microbiological status of the room was checked.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye served as control

Amount / concentration applied:

0.1 g of the test item was used for the study in undiluted state, as a single dose.

Duration of treatment / exposure:

The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application.

Number of animals or in vitro replicates:

3 male

Details on study design:

In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control. In the initial test slight irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal. Slight irritant effects were observed 24 hour after treatment. Following treatment of the second animal, the second confirmatory test was conducted using a third animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Time point:

other: 24h; 48h; 72h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

other: redness (conjunctival)

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0.66 - 1

Max. score:

1

Reversibility:

fully reversible within: 1 week

Results 4

Irritation parameter:

chemosis score

Remarks:

(conjunctival)

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0 - 0.66

Max. score:

0.66

Reversibility:

fully reversible within: 1 week

Results 5

Irritation parameter:

other: conjunctival discharge

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0 - 0.33

Max. score:

0.33

Reversibility:

fully reversible within: 1 week

Irritant / corrosive response data:

Treated and control eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application.
One hour after treatment some hyperemic blood vessels of the conjunctivae were observed in all animals. The swelling of the conjunctivae was different from normal in two animals. 24 hours after treatment some hyperemic blood vessels of the conjunctivae were observed in all animals. The swelling of the conjunctivae was different from normal in one animal. 48 hours after treatment some hyperemic blood vessels of the conjunctivae were observed in all animals. The swelling and the amount of discharge of the conjunctivae were different from normal in one animal. 72 hours after treatment some hyperemic blood vessels of the conjunctivae were observed in two animals. One animal became free of symptoms. 1 week after treatment all animals were free of symptoms, so the study was finished. During the study the control eyes of animals were symptom-free.

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test item applied to the rabbits' eye mucosa, caused slight conjunctival irritant effects, fully reversible within 1 week. No systemic toxicity was observed on the day of the treatment and during the 1-week observation period. The test item should be classified into GHS Category 2B.