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EC number: 700-584-3 | CAS number: 1217271-02-7
- 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:
- weight of evidence
- Study period:
- from 2014-04-14 to 2014-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [2,2-dimethyl-3-(morpholin-4-yl)propylidene][(5-{[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}-1,3,3-trimethylcyclohexyl)methyl]amine
- EC Number:
- 700-584-3
- Cas Number:
- 1217271-02-7
- Molecular formula:
- C28H52N4O2
- IUPAC Name:
- [2,2-dimethyl-3-(morpholin-4-yl)propylidene][(5-{[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}-1,3,3-trimethylcyclohexyl)methyl]amine
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S & K LAP Kft., 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: young adult animals
- Sex: male
- Weight at study initiation: 2958 - 3200 g
- Housing: single housing in metal cages
- Diet: CRLT/ny rabbit diet (Szindbád Kft., 2100 Gödöllő, Szárítópuszta, Hungary) ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- The test substance was applied once to each animal (single treatment). The eyes of the test animals were not washed out 24 hours after the application of test item, because the test substance was removed from the eye of the test animal by physiological mechanisms and the test item did not cause immediately severe irritation or corrosion after test item application.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours, then 1 week after the application. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of pain and/or distress were recorded twice daily, with a minimum of 6 hours between observations.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes of the test animals were not washed out 24 hours after the application of test item, because the test substance was removed from the eye of the test animal by physiological mechanisms and the test item did not cause immediately severe irritation or corrosion after test item application.
SCORING SYSTEM:
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (2012-10-02).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 week
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Other effects:
- Signs of pain and distress as discharge were observed in all animals. These symptoms were detected between treatment day and day 2.
Any other information on results incl. tables
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 |
2, 1, 1 |
0, 0, 0 |
1, 1, 1 |
1, 1, 1 |
24 h |
2, 1, 1 |
0, 0, 0 |
1, 1, 1 |
1, 1, 1 |
48 h |
2, 1, 1 |
0, 0, 0 |
1, 1, 1 |
0, 0, 0 |
72 h |
2, 1, 0 |
0, 0, 0 |
1, 1, 0 |
0, 0, 0 |
Average 24h, 48h, 72h |
2.00, 1.00, 0.66 |
0, 0, 0 |
1.00, 1.00, 0.66 |
0.33, 0.33, 0.33 |
Reversibility*) |
c. |
- |
c. |
c. |
Average time for reversion |
72 h - 1 week |
- |
1 week |
48 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item Sika Hardener MI applied to the rabbits' eye mucosa caused slight to severe conjunctivae and slight to moderate cornea irritant effects, fully reversible within 1 week.
- Executive summary:
The acute eye irritation study of the test item Sika Hardener MI was performed in three New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2012). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A volume of 0.1 mL of the test item was used in pure state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48 and 72 hours, then 1 week after the application.
One hour after the treatment, slight conjunctival redness and chemosis, moderate to severe discharge, as well as slight to moderate cornea opacity were observed. The area of cornea involved was greater than three quarters, up to the whole area in all animals. 72 hours after treatment slight redness and slight to moderate cornea opacity were recorded. The area of cornea involved was greater than three quarters, up to the whole area. One animal became free of symptoms by this time point.
The individual scores (mean over the time points 24, 48 and 72 hours) for animal 1 were determined as: conjunctivae: 1, chemosis: 0.33, cornea: 2 and iris: 0. For animal 2 the following scores were determined: conjunctivae: 0.66, chemosis: 0.33, cornea: 1, iris:0, and for animal 3: conjunctivae: 1, chemosis: 0.33, cornea: 0.66 and iris: 0.
1 week after the treatment, all animals were free of symptoms, so the study was terminated. No systemic toxicity was observed on the day of the treatment and during the 1-week observation period. The body weight of animals corresponded to their species and age. Signs of pain and distress as discharge were observed in all animals. These symptoms were detected between treatment day and day 2.
The test item Sika Hardener MI applied to the rabbits' eye mucosa caused slight to severe conjunctivae and slight to moderate cornea irritant effects, fully reversible within 1 week.
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