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EC number: 606-548-2 | CAS number: 204254-84-2
- 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:
- 2006-03-01 to 2006-03-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive and done to a valid guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl (3aR,7R,7aR)-2,2-dimethyl-7-[(methylsulfonyl)oxy]-3a,6,7,7a-tetrahydro-1,3-benzodioxole-5-carboxylate
- EC Number:
- 606-548-2
- Cas Number:
- 204254-84-2
- Molecular formula:
- C13 H20 O7 S
- IUPAC Name:
- Ethyl (3aR,7R,7aR)-2,2-dimethyl-7-[(methylsulfonyl)oxy]-3a,6,7,7a-tetrahydro-1,3-benzodioxole-5-carboxylate
- Test material form:
- other: solid
- Details on test material:
- White to beige solid
Purity 99.2%
Expiry date: 21 December 2006
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age at treatment : 12-13 weeks
Standard Laboratory Conditions
Air-conditioned with ranges for room temperature 17-23 °C, relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room
cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during
the daytime light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd,
Füllinsdorf) and haysticks 4642 (batch no. 35/05 and 77/05, Provimi Kliba AG) were provided for gnawing.
Standard pelleted rabbit maintenance diet and community tap water were provided.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of each animal served as control
- Amount / concentration applied:
- 0.1 g per animal. It was not recorded whether the test material was ground to a fine dust as the current guideline recommends.
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3 (one male, two female)
- Details on study design:
- On the day of treatment, 0.1 g of the test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0.11
- Max. score:
- 13
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.00 and 0.00 for reddening, respectively, and 0.00 for chemosis for all three animals.
Any other information on results incl. tables
Eye Irritation Scores - Individual values:
Animal No. & Sex | Evaluation Interval | Corneal Opacity | Area of Corneal Opacity | Iris | Conjunctivae Redness | Conjunctivae Chemosis | Cumulative Score | Cumulative mean | Sclera |
91M | 1 Hour | 0 | 0 | 0 | 1 | 0 | 1.00 | 1 | |
92F | 1 Hour | 0 | 0 | 0 | 1 | 0 | 1.00 | 1.00 | 0 |
93F | 1 Hour | 0 | 0 | 0 | 1 | 0 | 1.00 | 1 | |
91M | 24 Hours | 0 | 0 | 0 | 1 | 0 | 1.00 | 0 | |
92F | 24 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.33 | 0 |
93F | 24 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0 | |
91M | 48 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0 | |
92F | 48 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | 0 |
93F | 48 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0 | |
91M | 72 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0 | |
92F | 72 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0.00 | 0 |
93F | 72 Hours | 0 | 0 | 0 | 0 | 0 | 0.00 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The single instillation of the test item into the conjunctival sac caused mild, early-onset and transient ocular changes, such as slight reddening of the conjunctivae and sclerae as well as slight ocular discharge. These effects were reversible and were no longer evident 24 or 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations.
No staining of the cornea, sclera or conjunctivae nor corrosion by the test item was observed.
The primary Eye Irritation Score for the test item was 0.11 (the maximum attainable score is 13.0).
Conclusion: The test item was not irritating in this study. - Executive summary:
Introduction: To assess the primary eye irritation potential of the test item, a primary eye irritation study was performed in three (one male and two females) young adult New Zealand White rabbits.
Methods: The left eye of each animal was exposed to the test item by instilling 0.1 g of the test item into the conjunctival sac. The treated eyes were not rinsed after instillation. Corneal, iridic, conjunctival and scleral irritation was evaluate at 1 , 24, 48 and 72 hours after instillation.
Results: The single instillation of the test item into the conjunctival sac caused mild, early-onset and transient ocular changes, such as slight reddening of the conjunctivae and sclerae as well as slight ocular discharge. These effects were reversible and were no longer evident 24 or 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No staining of the cornea, sclera or conjunctivae nor corrosion by the test item was observed. The primary Eye Irritation Score for the test item was 0.11 (the maximum attainable score is 13.0).
Conclusion: The test item was not irritating in this study.
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