Dimethyl sulphide

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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:

Dimethyl sulphide

EC Number:

200-846-2

EC Name:

Dimethyl sulphide

Cas Number:

75-18-3

Molecular formula:

C2H6S

IUPAC Name:

(methylsulfanyl)methane

Details on test material:

- Name: Dimethyl Sulphide
- Synonyms: DMS, dimethyl sulfure, sulfure de dimethyle, dimethyl sulfide
- Batch number: C8753
- Description: Colorless liquid
- Storage condition: At room temperature
- Purity: 99.7%
- Purity test date: 09/01/2015
- Expiration date of the lot/batch: 08 April 2017

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Argenvilliers, France.
- Age at study initiation: 3 to 4 months old
- Weight at study initiation: 3130 g to 3510 g
- Housing: individually housed in noryl cages
- Diet: pelleted breeding diet "type 110C", ad libitum
- Water:. ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 5 to 15
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

not rinced

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : no

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

chemosis score

Basis:

other: #1 and 2

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

iris score

Basis:

animal: #1, 2 and 3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2 and 3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No ocular reactions were observed in the right untreated control eye.

First animal (D31531)
In the left treated eye of male D31531, marked chemosis (grade 3) and severe redness (grade 3) of the conjunctiva were recorded 1 hour after test item administration.
Chemosis became slight (grade 1) and redness became moderate (grade 2) on Day 2.
No iris and corneal lesions were observed.

Second and third animals (D31532 and D31533)
In the left treated eye of males D31532 and D31533, marked chemosis (grade 3) and moderate redness (grade 2) of the conjunctiva were recorded 1 hour after test item administration.
Chemosis became moderate (grade 2) on Day 2 and then slight (grade 1) on Day 3.
Moderate redness (grade 2) persisted on Day 3 for male D31533 or on Day 2 for male D31532, becoming slight (grade 1) on Day 3.
No iris and corneal lesions were observed.

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
¿ chemosis: 0.3, 1.0 and 1.0,
¿ redness of the conjunctiva: 0.7, 1.0 and 1.3,
¿ iris lesions: 0.0, 0.0 and 0.0,
¿ corneal opacity: 0.0, 0.0 and 0.0.

Other effects:

No unscheduled deaths occurred during the study and no clinical signs were noted in any animals. The body weight of the animals was unaffected by the test item treatment.

Any other information on results incl. tables

The potential eye irritant properties of Dimethyl Sulphide following a single ocular administration to rabbits was evaluated in a study conducted in compliance with the OECD guideline No. 405. Dimethyl Sulphide was first administered to a single male New Zealand White rabbit. As mean value from grading at 24, 48 and 72 hours after instillation was [0-2] for conjunctival edema (chemosis) and for conjunctival redness, [0 -1] for iris lesions and for corneal opacity, the test item was administered in the left eye of two other animals. The test item was administered in the conjunctival sac of the left eye. The right eye remained untreated and acted as control.A dosage-volume of 0.1 mL/animal was used.For the first animal, a local anesthetic was used prior to treatment and the animals were placed under systemic analgesia throughout the study. The eyes were not rinsed before the 24-hour scoring. Each animal was observed once a day for mortality and clinical signs.Ocular reactions were observed approximately 1, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. Body weight was recorded on the day of treatment and at the end of the evaluation of ocular reactions (Day 4). On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination.

No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.The body weight of the animals was unaffected by the test item treatment.In the left treated eye of the first animal, marked chemosis and severe redness of the conjunctiva were recorded 1 hour after test item administration. Chemosis became slight and redness was moderate on Day 2. No iris and corneal lesions were observed. In the left treated eye of the second and third animals, marked chemosis and moderate redness of the conjunctiva were recorded 1 hour after test item administration. Chemosis became moderate on Day 2 and then slight on Day 3. Moderate redness persisted on Day 3 for the third animal or on Day 2 for the second animal, becoming slight on Day 3. No iris and corneal lesions were observed.

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:

.       chemosis: 0.3, 1.0 and 1.0,

.       redness of the conjunctiva: 0.7, 1.0 and 1.3,

.       iris lesions: 0.0, 0.0 and 0.0,

.       corneal opacity: 0.0, 0.0 and 0.0.

Dimethyl Sulphide was slightly irritant when administered by ocular route to rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dimethyl Sulphide was slightly irritant when administered by ocular route to rabbits.

Executive summary:

The potential eye irritant properties of Dimethyl Sulphide, following a single ocular administration to rabbits was evaluated in a study conducted in compliance with the OECD guideline No. 405. Dimethyl Sulphide was first administered to a single male New Zealand White rabbit. As mean value from grading at 24, 48 and 72 hours after instillation was [0-2] for conjunctival edema (chemosis) and for conjunctival redness, [0 -1] for iris lesions and for corneal opacity, the test item was administered in the left eye of two other animals. The test item was administered inthe conjunctival sac of the left eye. The right eye remained untreated and acted as control.A dosage-volume of 0.1 mL/animal was used.For the first animal, a local anesthetic was used prior to treatment and the animals were placed under systemic analgesia throughout the study. The eyes were not rinsed before the 24-hour scoring. Each animal was observed once a day for mortality and clinical signs. Ocular reactions were observed approximately 1, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. Body weight was recorded on the day of treatment and at the end of the evaluation of ocular reactions (Day 4). On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination.

No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.The body weight of the animals was unaffected by the test item treatment.In the left treated eye of the first animal, marked chemosis and severe redness of the conjunctiva were recorded 1 hour after test item administration. Chemosis became slight and redness was moderate on Day 2. No iris and corneal lesions were observed. In the left treated eye of the second and third animals, marked chemosis and moderate redness of the conjunctiva were recorded 1 hour after test item administration. Chemosis became moderate on Day 2 and then slight on Day 3. Moderate redness persisted on Day 3 for the third animal or on Day 2 for the second animal, becoming slight on Day 3. No iris and corneal lesions were observed.

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:

chemosis: 0.3, 1.0 and 1.0,

redness of the conjunctiva: 0.7, 1.0 and 1.3,

iris lesions: 0.0, 0.0 and 0.0,

corneal opacity: 0.0, 0.0 and 0.0.

Dimethyl Sulphidewas slightly irritant when administered by ocular route to rabbits.