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EC number: 606-834-7 | CAS number: 21806-61-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted on 9 October 2017 (corrected on 14 June 2021)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5H-1,2λ⁶-oxathiole-2,2-dione
- EC Number:
- 606-834-7
- Cas Number:
- 21806-61-1
- Molecular formula:
- C3H4O3S
- IUPAC Name:
- 5H-1,2λ⁶-oxathiole-2,2-dione
- Details on test material:
- Physical appearance (with Color): white solid
Lot No.: N222070161
Molecular formula: C3H4O3S
Molecular weight: 120.12
Stability: Stable in room temperature
Date of Manufacture: 2022.7.1
Date of Expiry: 2023.6.30
Storage Conditions: Cool and dry (+2 to +8° C)
Test Item Code by Test Facility: D1547-001
Constituent 1
- Specific details on test material used for the study:
- Physical appearance (with Color): white solid
Lot No.: N222070161
Molecular formula: C3H4O3S
Molecular weight: 120.12
Stability: Stable in room temperature
Date of Manufacture: 2022.7.1
Date of Expiry: 2023.6.30
Storage Conditions: Cool and dry (+2 to +8° C)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Oryctolagus cuniculus
- Details on test animals or tissues and environmental conditions:
- No. of Animals / Test: Initial Test: 1 Female
Remaining two animals were sacrificed by overdose intravenous administration of sodium thiopentone.
(Females used were nulliparous and non-pregnant).
Age at Receipt: 5 months
Body Weight at Receipt: 2.18946 kg to 2.21835 kg
Animal Identification:
Acclimatization: Cage cards
Treatment Period: Cage cards and last 4 digits of the animal number was written on the ear of each rabbit using black permanent marker pen.
Animal No: Nc3720.
Husbandry
a. Environmental Conditions:
Animals were housed under standard laboratory conditions, in an environmentally monitored air-conditioned room with adequate fresh air supply (12 to 15 Air changes per hour), room temperature 19.2°C to 22.8°C and relative humidity 46% to 69% with 12 hours fluorescent light and 12 hours dark cycle. The temperature and relative humidity was recorded once daily.
b. Housing:
The animals were housed individually in stainless steel wire mesh cage (Size: L 24 x B 18 x H 18 inches) having facilities for holding pelleted feed and drinking water.
c. Feed:
Altromin Maintenance Diet for rabbits (manufactured by Altromin Spezialfutter GmbH & Co. KG) was provided ad libitum to the rabbits throughout the experimental period. The contaminant analysis test report for the feed is presented as Annexure 2.
d. Water:
Water was provided ad libitum throughout the acclimatization and experimental period. Deep bore-well water passed through reverse osmosis unit was provided in plastic water bottles with stainless steel sipper tubes.
Acclimatization:
Healthy young adult animals were acclimatized for a period of five days for initial test to the experimental room conditions prior to treatment and were observed for clinical signs once daily. Veterinary examination of all the animals was performed on the day of receipt.
Preparation of Animals:
Both the eyes of each experimental animal selected for testing were examined within 24 hours before initiating the treatment using ophthalmoscope. Only those animals with absence of signs of eye irritation, ocular defects or pre-existing corneal injury were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- yes, concurrent negative control
- Amount / concentration applied:
- volume of 0.1 mL (94.8 mg) of pulverized test item was instilled to the initial test animal
- Duration of treatment / exposure:
- After pre-instillation procedure, test item was instilled into the conjunctival sac of the left eye by gently pulling the lower lid away from the eye ball. Then the eye lids were gently held together for a few second to prevent loss of test item. The right eye remained untreated and served as the control.
The eye was rinsed using 0.9% w/v normal saline after 1 hour of treatment (post treatment). - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- Initial Test: 1 Female
Remaining two animals were sacrificed by overdose intravenous administration of sodium thiopentone.
(Females used were nulliparous and non-pregnant). - Details on study design:
- The experiment was performed in one phase that is initial test. As there was corrosive effect observed, confirmatory test was not conducted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Area of cornea involved: Score 4 ( at 24/48/72 h and Day 7/14/21, Max. score 4)
- Basis:
- mean
- Remarks:
- Animal No.: Nc3720
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal No.: Nc3720
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal No.: Nc3720
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal No.: Nc3720
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Scoring of Ocular Lesions:
In initial test, treated eye (left) of revealed ocular lesions like redness (diffuse, crimson color; individual vessels not easily discernible) and chemosis (some swelling above normal) at 1st hour observation. At 24 and 48 hours observation, ocular lesions like redness (diffuse, crimson color; individual vessels not easily discernible), chemosis (obvious swelling, with partial eversion of lids), corneal opacity (easily discernible translucent area; details of iris slightly obscured) and area of opacity (greater than three-quarters, up to whole area). At 72 hours and on day 7 observation ocular lesions like redness (diffuse, crimson color; individual vessels not easily discernible), chemosis (some swelling above normal), corneal opacity (easily discernible translucent area; details of iris slightly obscured) and area of opacity (greater than three-quarters, up to whole area). On days 14 and 21 ocular lesions like redness (diffuse, crimson color; individual vessels not easily discernible), corneal opacity (easily discernible translucent area; details of iris slightly obscured) and area of opacity (greater than three-quarters, up to whole area) were observed.
Slit Lamp Examination:
In initial test, ocular lesions like conjunctivitis and corneal opacity were observed at 24, 48, 72 hours, on days 7 and 14 observation; conjunctivitis, corneal opacity and corneal ulceration/abrasion on day 21 observation during slit lamp examination.
Evaluation of Scoring:
For initial test, the mean score calculated across 3 scoring times (approximately 24, 48 and 72 hours after test item instillation) for corneal opacity, iris, conjunctival redness and conjunctival chemosis were 2, 0, 2 and 1.67 respectively.
Necropsy:
The initial test animal was sacrificed by intravenous administration of sodium thiopentone and subjected to Necropsy. The external gross pathological findings like Eye (left) - conjunctiva, discoloration, red - opacity, discharge, white were observed and there were no internal gross pathological changes. - Other effects:
- Clinical Signs of Toxicity and Mortality:
No treatment related clinical signs of toxicity and mortality was observed in initial test animal.
Body Weight:
No treatment related changes were noted in body weight and percent change in body weight with respect to day 1 in initial test. Animal revealed physiologically normal increase in body weight.
Any other information on results incl. tables
- INDIVIDUAL ANIMAL SLIT LAMP EXAMINATION RECORD
Initial Test Sex: Female Dose: 0.1 mL/animal Animal No.: Nc3720 | ||||||||||
Observation Period | Ocular Lesions | |||||||||
Conjunctiva | Iris | Cornea | ||||||||
Redness | Chemosis | Opacity | Area | |||||||
Eyes | LE | RE | LE | RE | LE | RE | LE | RE | LE | RE |
1 hr | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | - | - |
24 hrs | 2 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 4 | - |
48 hrs | 2 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 4 | - |
72 hrs | 2 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 4 | - |
Day 7 | 2 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 4 | - |
Day 14 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 4 | - |
Day 21 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 4 | - |
Mean Tissue Score | 2 | 0 | 1.67 | 0 | 0 | 0 | 2 | 0 | - | - |
hr: hour; hrs: hours; LE: Left Eye (Treated Eye); RE: Right Eye (Untreated control Eye); -: Not applicable.
Mean Tissue Score = (24 hr+48 hr+72 hr)/3
Redness: 0: Normal; 2: Diffuse, crimson color; individual vessels not easily discernible.
Chemosis: 0: Normal; 1: Some swelling above normal; 2: obvious swelling, with partial eversion of lids.
Iris: 0: Normal.
Opacity: 0: No ulceration or opacity; 2: Easily discernible translucent area; details of iris slightly obscured.
Area: 4: Greater than three-quarters, up to whole area.
Initial Test Sex: Female Dose: 0.1 mL/animal Animal No.: Nc3720 | ||||||||||||
| Day 2 (24 hours) | Day 3 (48 hours) | Day 4 (72 hours) | Day 7 | Day 14 | Day 21 | ||||||
Eye | LE | RE | LE | RE | LE | RE | LE | RE | LE | RE | LE | RE |
Lids | 13 | N | 13 | N | 13 | N | 13 | N | 13 | N | 13 | N |
Ducts | N | N | N | N | N | N | N | N | N | N | N | N |
Cornea | 24 | N | 24 | N | 24 | N | 24 | N | 24 | N | 24,16 | N |
Pupil | N | N | N | N | N | N | N | N | N | N | N | N |
Sclera | N | N | N | N | N | N | N | N | N | N | N | N |
Ciliary Bodies | N | N | N | N | N | N | N | N | N | N | N | N |
Iris | N | N | N | N | N | N | N | N | N | N | N | N |
Aqueous Humour | N | N | N | N | N | N | N | N | N | N | N | N |
Lens | N | N | N | N | N | N | N | N | N | N | N | N |
Vitreous Humour | N | N | N | N | N | N | N | N | N | N | N | N |
LE: Left Eye; RE: Right Eye; N: Normal/No Abnormality Detected; 13: Conjunctivitis; 24: Corneal Opacity; 16: Corneal ulceration/ abrasion.
Phase of the Experiment
| Dose (mL/animal) | Animal No. | Sex | Fate | Gross Pathology Findings | |
External | Internal | |||||
Initial Test | 0.1 | Nc3720 | Female | TS | Eye (Left) - Conjunctiva, discoloration, red, Opacity, discharge, white | NAD |
TS: Terminal Sacrifice; NAD: No Abnormality Detected.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the above results of the experiment and under the experimental conditions employed, it is concluded that the mean score of test item, 5H-1,2-oxathiole 2,2-dioxide is classified as “Category 1 (Serious eye damage / Irreversible effects on eye)” as per the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
The test item, 5H-1,2-oxathiole 2,2-dioxide was evaluated for In Vivo Eye Irritation/ Serious Eye Damage in New Zealand White Rabbits.
Both the eyes of each experimental animal were examined within 24 hours before the treatment. The animals with absence of signs of eye irritation, ocular defects or pre-existing corneal injury were used for the treatment. The pH of test item was 5.30 as per in-house pH determination.
The initial test was conducted using single female rabbit, as there was corrosive effect observed, confirmatory test was not conducted. The systemic analgesic tramadol hydrochloride injection (2.5 mg/kg) and two drops of topical ocular anesthetic (0.5% tetracaine hydrochloride) were given to the animal at sixty minutes and five minutes prior to test item instillation respectively. The 0.1 mL (94.8 mg) of test item was instilled into the conjunctival sac of the left eye and right eye served as control. The eyes were scored approximately at 1, 24, 48, 72 hours, on days 7, 14 and 21. Slit lamp examination was carried out using fluorescein strips (fluorescein sodium ophthalmic strip USP) and were scored approximately at 24, 48, 72 hours, on days 7, 14 and 21.
The initial test animal was observed twice daily for clinical signs of toxicity and mortality. No treatment related clinical signs of toxicity and mortality were observed in initial test animal after the test item instillation.
In initial test, treated eye (left) revealed ocular lesions like redness and chemosis at 1st hour observation; Redness, chemosis and corneal opacity at 24, 48, 72 hours and on day 7 observation; Redness and corneal opacity on days 14 and 21 observation.
In initial test, ocular lesions like conjunctivitis and corneal opacity were observed at 24, 48, 72 hours, on days 7 and 14 observation; conjunctivitis, corneal opacity and corneal ulceration/abrasion on day 21 observation during slit lamp examination.
The body weights were recorded on the day of receipt, on the day of treatment (prior to instillation of test item) and weekly thereafter of the experiment. No treatment related changes were noted in body weight and percent change in body weight with respect to day 1. Animal revealed physiologically normal increase in body weight in initial test.
At termination, the initial test animal was sacrificed by intravenous administration of sodium thiopentone and subjected to Necropsy. The external gross pathological findings like Eye (left) - conjunctiva, discoloration, red - opacity, discharge, white were observed and there were no internal gross pathological changes. Remaining two animals were sacrificed by overdose intravenous administration of sodium thiopentone and carcass were disposed.
In initial test animal, the mean score calculated across 3 scoring times (approximately 24, 48 and 72 hours after test item instillation) for corneal opacity, iris, conjunctival redness and conjunctival chemosis were 2, 0, 2 and 1.67 respectively.Based on the above results of the experiment and under the experimental conditions employed, it is concluded that the mean score of test item, 5H-1,2-oxathiole 2,2-dioxide is classified as “Category 1 (Serious eye damage / Irreversible effects on eye)”.
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