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EC number: 940-820-4 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in a GLP laboratory using OECD Testing Guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see box below
- Principles of method if other than guideline:
- The relative humidity (38 - 76%) and temperature (16.6 – 23.4 oC) were out of the target range during the study.
These deviations are considered to have no impact on the outcome of the study and interpretation of the results. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1H-Imidazolium, 3-ethyl-1-methyl-, C9-14-branched alkylbenzenesulfonates
- IUPAC Name:
- 1H-Imidazolium, 3-ethyl-1-methyl-, C9-14-branched alkylbenzenesulfonates
- Reference substance name:
- EMI-DBS
- IUPAC Name:
- EMI-DBS
- Reference substance name:
- 1065642-34-3
- Cas Number:
- 1065642-34-3
- IUPAC Name:
- 1065642-34-3
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- Substance name: EMI-DBS
Description of test item: Yellow paste
Storage conditions: Room temperature (15 - 25°C), in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
Justification of strain: The New Zealand White rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined approximately one hour before starting the study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
Number of animals: 3
Age of animals at treatment: ~12 weeks old (adult)
Sex: Male
Body weight range at the
- beginning of the life phase: 3105-3202 g
- end of the life phase: 3780-3882 g
Date of receipt: 24 August 2011
Acclimatization time: 13 days
Animal identification: The individual identification was by engraved ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.
Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 607
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 16.6 – 23.4°C
Relative humidity: 38-76%
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
Ventilation: 15-20 air exchanges/hour
The environmental parameters were recorded twice daily during the study. Variations from the target humidity and temperature range were observed during the study. These deviations were considered to have no impact on the animal health, as certified by the Clinical Veterinarian, or on the outcome of the study and interpretation of the results.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A single dose of 0.1 ml of the paste test item EMI-DBS was administered to each animal.
- Duration of treatment / exposure:
- The test item was applied once and observations made up to 3 weeks after application.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48, 72 hours and 1, 2 and 3 weeks after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill- health during the study were recorded.
At the end of the observation period, each animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol® 40% anaesthesia. Death was verified by checking pupil and corneal reflex and the absence of respiration. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application of the Test Item
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition and any with ocular lesions were rejected.
An initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test item. The contralateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made according a six point scale.
After consideration of the ocular responses produced in the first animal, two additional animals were treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Considering readings at 24, 48 and 72 hours after treatment
- Score:
- 1.33
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 1.67
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 1.67
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- iris score
- Basis:
- other: animal number 1, 2 and 3
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 0
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- other: Conjunctivae redness
- Basis:
- animal #1
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 2.33
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- other: Conjunctivae redness
- Basis:
- animal #2
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 2.67
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- other: Conjunctivae redness
- Basis:
- animal #3
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 2.67
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 3
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 2.33
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- other: Conjunctivae discharge
- Basis:
- animal #1
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 3
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- other: Conjunctivae discharge
- Basis:
- animal #2
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 2.33
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- other: Conjunctivae discharge
- Basis:
- animal #3
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 2.33
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: Considering readings at 24, 48 and 72 hours after the treatment
- Score:
- 2.67
- Reversibility:
- not fully reversible within: 3 weeks
- Remarks on result:
- other: Animal's individual mean score
- Other effects:
- There was no mortality observed during the study. The body weight and body weight change were considered to be normal with no indication of treatment related effect. There were no clinical signs observed that could be related to treatment.
Any other information on results incl. tables
Examination of eye-irritancy
The eyes were examined at 1, 24, 48, 72 hours and 1, 2 and 3 weeks after the application.
Initial Pain Reaction (IPR) (score 2 or 3) was observed in all animals after test item administration.
One hour after the application: Conjunctival redness (score 2), conjunctival chemosis (score 3) and discharge (score 3) were observed in all animals. All animals showed corneal opacity (score 1, area 4).
At 24 hours after treatment: Conjunctival redness, chemosis and discharge (score 3) were seen in all rabbits. All animals showed corneal opacity (score 1, area 4).
At 48 hours after treatment: Conjunctival redness (score 2 or 3), chemosis and discharge (score 3 - 3) were seen in all rabbits. All animals showed corneal opacity (score 1 or 2 , areas 4, 3 or 2).
At 72 hours after treatment: Conjunctival redness (score 2), chemosis (score 1, 2 or 3) and discharge (score 1 or 3) were seen in all rabbits. All animals showed corneal opacity (score 2 , areas 1 or 3).
At 1 week after treatment: Conjunctival redness (score 1 or 2) and discharge (score 1 or 3) were seen in all rabbits. Conjuctival chemosis (score 1 or 2) was observed in two animals. Two animals showed corneal opacity (score 2 , area 3).
At 2 weeks after treatment: Conjunctival redness (score 1) was seen in all rabbits. Conjuctival chemosis (score 1) and discharge (score 1) were observed in two animals. Two animals showed corneal opacity (score 2 , areas 1 or 2). In two animals, vascularisation was observed on the surface of the cornea. the extension of the vascularisation is not greater than 1/4 of the surface of the cornea.
At 3 weeks after treatment: Conjunctival redness (score 1) was seen in all rabbits. Conjuctival chemosis (score 1) was observed in one animal and discharge (score 1) was observed in two animals. Two animals showed corneal opacity (score 2 , areas 1 or 2). In one animals, vascularisation was observed on the surface of the cornea. The extension of the vascularisation is greater than 1/4 of the surface of the cornea.
The study was terminated after the 3-week observation.
The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
Animal Number |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
|||
00369 |
1.33 |
0.00 |
2.33 |
3.00 |
3.00 |
00445 |
1.67 |
0.00 |
2.67 |
2.33 |
2.33 |
00443 |
1.67 |
0.00 |
2.37 |
2.67 |
2.33 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item EMI-DBS, applied to rabbit eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 2 weeks after application. The effects were not fully reversible within 3 weeks. According to Regulation (EC) No 1272/2008, EMI-DBS requires classification as an eye irritant (Irreversible effects on the eye/serious damage to eyes (Category 1)).
- Executive summary:
The eye irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 405. The study was conducted by applying 0.1 ml of the test item in a single dose into the conjunctival sac of the left eye of male New Zealand White rabbits. Individual body weight was recorded at the beginning and end of the study. Morbidity and clinical signs of toxicity were checked daily. The eyes were examined at 1, 24, 48, 72 hours and 1, 2 and 3 weeks after the application.
No adverse effects on body weight development were noted during the study period. The general state and behavior of animals were normal throughout the study period. During the study, no signs of eye irritation were observed in the control eye of all animals.
Initial Pain Reaction (IPR) (score 2 or 3) was observed in all animals after test item administration.
One hour after the application: Conjunctival redness (score 2), conjunctival chemosis (score 3) and discharge (score 3) were observed in all animals. All animals showed corneal opacity (score 1, area 4). At 24 hours after treatment: Conjunctival redness, chemosis and discharge (score 3) were seen in all rabbits. All animals showed corneal opacity (score 1, area 4). At 48 hours after treatment: Conjunctival redness (score 2 or 3), chemosis and discharge (score 3 - 3) were seen in all rabbits. All animals showed corneal opacity (score 1 or 2 , areas 4, 3 or 2). At 72 hours after treatment: Conjunctival redness (score 2), chemosis (score 1, 2 or 3) and discharge (score 1 or 3) were seen in all rabbits. All animals showed corneal opacity (score 2 , areas 1 or 3). At 1 week after treatment: Conjunctival redness (score 1 or 2) and discharge (score 1 or 3) were seen in all rabbits. Conjuctival chemosis (score 1 or 2) was observed in two animals. Two animals showed corneal opacity (score 2 , area 3). At 2 weeks after treatment: Conjunctival redness (score 1) was seen in all rabbits. Conjuctival chemosis (score 1) and discharge (score 1) were observed in two animals. Two animals showed corneal opacity (score 2 , areas 1 or 2). In two animals, vascularisation was observed on the surface of the cornea. the extension of the vascularisation is not greater than 1/4 of the surface of the cornea. At 3 weeks after treatment: Conjunctival redness (score 1) was seen in all rabbits. Conjuctival chemosis (score 1) was observed in one animal and discharge (score 1) was observed in two animals. Two animals showed corneal opacity (score 2 , areas 1 or 2). In one animals, vascularisation was observed on the surface of the cornea. The extension of the vascularisation is greater than 1/4 of the surface of the cornea. The study was terminated after the 3-week observation. The test item EMI-DBS, applied to rabbit eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 2 weeks after application. The effects were not fully reversible within 3 weeks.
According to Regulation (EC) No 1272/2008, EMI-DBS requires classification as an eye irritant (Irreversible effects on the eye/serious damage to eyes (Category 1)).
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