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EC number: 611-205-5 | CAS number: 5486-79-3
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate
- Cas Number:
- 5486-79-3
- Molecular formula:
- C12H20ClNO5
- IUPAC Name:
- 2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 01805 1216
- Expiration date of the lot/batch: 03 2018
- Purity test date: 03 2017
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: 11-12 weeks old
- Weight at study initiation: 2906-3220 g
- Housing: animals were housed individually in metal cage
- Diet (e.g. ad libitum): S&K LAP rabbbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11-12-13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 30-70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12-12
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test item was used for the study in undiluted form, as a single dose. - Duration of treatment / exposure:
- The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
- Observation period (in vivo):
- 3 weeks
- Number of animals or in vitro replicates:
- 3
- Details on study design:
-
SCORING SYSTEM: Draize (1959) and OECD 405 (24 April 2002)
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 weeks
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1,2,3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 weeks
- Irritant / corrosive response data:
- Treated and control eyes were examined at 1, 24, 48 and 72 hours then 1, 2 and 3 weeks after the application.
One hour after treatment some hyperemic blood vessels (score 1) were observed in all animals. The swelling of the conjunctivae was different from normal (score 1) in two animals (No.: 774, 785). Discharge with moistening of the lids and hairs just adjacent to lids (score 2) was recorded in animal No.: 790. Diffuse areas of opacity were detected and the details of iris were clearly visible (score 1) in animal No.: 785. The area of cornea involved was greater than three quarters, up to the whole area (score 4).
24 hours after treatment diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2), the swelling of the conjunctiva with lids about half closed (score 3) and the discharge of the conjunctivae moistened lids and hairs on considerable area around the treated eye (score 3) were recorded in two animals (No.: 774, 785). Besides, easily discernible translucent areas of the cornea were found and the details of iris were slightly obscured (score 2) in same animals. The area of cornea involved was greater than three quarters, up to the whole area (score 4). Animal No.: 790 became free of symptoms.
48 hours after treatment diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) and the swelling of the conjunctiva with lids about half closed (score 3) were observed in two animals (No.: 774, 785). Discharge of the conjunctivae moistened lids and hairs on considerable area around the treated eye (score 3) were recorded in animal No.: 774. Discharge with moistening of the lids and hairs just adjacent to lids (score 2) was detected in animal No.: 785. Easily discernible translucent areas of the cornea were found and the details of iris were slightly obscured (score 2) in two animals (No.: 774, 785). The area of cornea involved was greater than three quarters, up to the whole area (score 4). Besides, another sign as pinkish discharge around the eye was observed in two animals (No.: 774, 785). Animal No.: 790 was free of symptoms.
72 hours after treatment some hyperemic blood vessels (score 1) were observed in animal No.: 774. Diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) was recorded in animal No.: 785. The swelling of the conjunctiva with lids about half closed (score 3) was detected in animal No.: 774 and the swelling of the conjunctivae was different from normal (score 1) in animal No.: 785. Discharge of the conjunctivae moistened lids and hairs on considerable area around the treated eye (score 3) was recorded in animal No.: 774.
slightly obscured (score 2) in animal No.: 774 and diffuse areas of opacity were detected and the details of iris were clearly visible (score 1) in animal No.: 785. The area of cornea involved was greater than three quarters, up to the whole area (score 4) in both animals. Animal No.: 790 was free of symptoms.
1 week after treatment some hyperemic blood vessels (score 1) were observed in two animals (No.: 774, 785). The swelling of the conjunctivae was different from normal (score 1) in animal No.: 774. Discharge of the conjunctivae moistened lids and hairs on considerable area around the treated eye (score 3) was recorded in animal No.: 774. Diffuse areas of opacity were detected and the details of iris were clearly visible (score 1) in animal No.: 774. The area of cornea involved was greater than half, but less than three quarters (score 3).
2 weeks after treatment some hyperemic blood vessels (score 1) were observed in animal No.: 774. The swelling of the conjunctivae was different from normal (score 1) in animal No.: 774. Diffuse areas of opacity were detected and the details of iris were clearly visible (score 1) in animal No.: 774. The area of cornea involved was greater than half, but less than three quarters (score 3). Two animals (No.: 785, 790) were free of symptoms.
3 weeks after the treatment the study was finished, because all animals were free of symptoms.
During the study the control eyes of animals were symptom-free.
Detailed eye irritation results are shown in Appendix I.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
cornea opacity : 2.00, 1.66, 0.00
iris : 0.00, 0.00, 0.00
redness : 1.66, 2.00, 0.00
chemosis : 3.00, 2.33, 0.00
discharge : 3.00, 1.66, 0.00
No systemic toxicity was observed on the day of the treatment and during the 21-day observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was observed in all animals between the treatment day and Day 9.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In conclusion, test item 3,4-O-dimethyl methyldopa monohydrochloride monohydrate (DMAKS) applied to the rabbits' eye mucosa caused slight to severe conjunctival and slight to moderate cornea irritant effects which were fully reversible within 3 weeks.
On basis of the conjunctivae irritation sign as chemosis observed in animals, the test item should be classified as “R36 – Irritating to eyes” according to Directive 2001/59/EC.
According to Regulation (EC) No. 1272/2008, the test item should be classified into “Category 2 (reversible effects on the eye/irritating to eyes)” on basis of conjunctivae irritation sign as chemosis and cornea opacity.
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