Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 210-868-4 | CAS number: 624-89-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 15-NOV-1993 to 12-APR-1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study similar to OECD testing guideline and performed according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl methyl sulphide
- EC Number:
- 210-868-4
- EC Name:
- Ethyl methyl sulphide
- Cas Number:
- 624-89-5
- Molecular formula:
- C3H8S
- IUPAC Name:
- (methylsulfanyl)ethane
- Details on test material:
- - Name of test material (as cited in study report): methyl ethyl sulfide
- Molecular formula (if other than submission substance): C3H8S
- Molecular weight (if other than submission substance): 76.16 g
- Smiles notation (if other than submission substance): C(SC)C
- InChl (if other than submission substance): InChI=1/C3H8S/c1-3-4-2/h3H2,1-2H3
- Substance type: pure active substance
- Physical state: clear colorless liquid
- Stability under test conditions: data not available
- Storage condition of test material: room temperature, protected from light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's rabbitry, Thompson station, TN
- Age at study initiation: adults
- Weight at study initiation: 3.052 to 3.117 kg for males and 2.590 to 3.228 kg for females
- Housing: individually in suspended stainless steel cages
- Diet: Purina certified rabbit chow #5322, ad libitum
- Water: municipal tap water treated by reverse osmosis or deionization, ad libitum
- Acclimation period: for a minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 53 to 72°F (# 11.7 to 22.2°C)
- Humidity: 40 to 57%
- Air changes: 10 to 12 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From 03-JAN-1994 to 17-JAN-1994
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- up to 14 days
- Number of animals or in vitro replicates:
- 6 (2 males and 4 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: any residual test material was gently rinsed from the eye using 0.9% physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: auxiliary light source + fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h to day 7
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h to day 7
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: Day 7 to day 14
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 7 to day 14
- Irritant / corrosive response data:
- Exposure to the test article produced corneal opacity in 5/6 test eyes at the 24 hour scoring interval. The corneal injury was confirmed by positive fluorescein dye retention. The corneal opacity diminished during the remainder of the test period and resolved in all test eyes by study day 7. Iritis was observed in 6/6 test eyes by the 24 hour scoring interval and resolved completely in all animals by study day 7. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation generally diminished during the remainder of the test period and resolved completely in all animals by study day 14. Additional ocular findings included sloughing of the corneal epithelium, which was noted in 6/6 test eyes.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
1/1/1/1/1/0 |
2/2/1/2/2/2 |
2/2/2/2/2/2 |
24 h |
0/2/2/2/2/2 |
1/0/0/0/1/1 |
2/2/2/2/2/2 |
1/2/2/2/2/2 |
48 h |
0/0/0/0/2/2 |
1/0/0/0/0/1 |
2/2/2/2/2/3 |
1/1/1/1/1/2 |
72 h |
0/0/0/0/0/2 |
0/0/0/0/0/1 |
1/2/2/2/2/2 |
1/1/1/1/1/2 |
Average 24h, 48h, 72h |
0/ 0.7/0.7/0.7/1.3/2 Mean = 0.9 |
0.7/0/0/0/0.3/1 Mean = 0.3 |
1.7/2/2/2/2/2.3 Mean = 2 |
1/1.3/1.3/1.3/1.3/2 Mean = 1.4 |
7 days |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/2 |
0/0/0/1/0/1 |
10 days |
-/-/-/0/-/0 |
-/-/-/0/-/0 |
-/-/-/0/-/2 |
-/-/-/0/-/1 |
14 days |
-/-/-/-/-/0 |
-/-/-/-/-/0 |
-/-/-/-/-/0 |
-/-/-/-/-/0 |
Reversibility*) |
c |
c |
c |
c |
Average time (unit) for reversion |
48h to day 7 |
24h to day 7 |
Day 7 to day 14 |
Day 7 to day 14 |
*) Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Conclusions:
- Methyl ethyl sulfide is classified as irritating (category 2) to the eye according to criteria of REGULATION (EC) No 1272/2008.
- Executive summary:
The potential eye irritant and/or corrosive effects of Methyl Ethyl Sulfide were evaluated on New Zealand White rabbits (method similar to OECD testing guideline and according to GLP). Each of six rabbits received a 0.1 ml dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 14 days following dosing.
The mean scores at 24, 48 and 72h were as follow:
- Cornea: 0.9
- Iris: 0.3
- Conjonctivae (redness): 2.0
- Chemosis: 1.4
All the effects were completely reversible at the end of the observation period (up to day 14) .
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
