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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
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
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
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
Irritation parameter:
iris score
Basis:
animal: #1, 2 and 3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
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.