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EC number: 211-560-2 | CAS number: 665-66-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431, April 13, 2004 (“In vitro Skin Corrosion: Human Skin Model Test”)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method: Part B (Methods for the determination of toxicity and other health effects: In Vitro Skin Corrosion: Human Skin Model Test; Official Journal of the European Union, No. L 142)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amantadine hydrochloride
- EC Number:
- 211-560-2
- EC Name:
- Amantadine hydrochloride
- Cas Number:
- 665-66-7
- Molecular formula:
- C10H17N.ClH
- IUPAC Name:
- adamantan-1-amine hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): Adamantylamin hydrochlorid
- Analytical purity: 99.7 g/100 g
- Test-substance No.: 11/0506-1
- Lot/batch No.: 20110315
- Homogeneity: The test substance was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed.
- Other:
pH-value: 5.6 at 20°C (10% aqueous solution)
Constituent 1
Test animals
- Species:
- other: in vitro test on three dimensional human epidermis model (EpiDermTM model which consists of normal human-derived epidermal keratinocytes cultured to form a multi layered, highly differentiated model of the human epidermis.)
- Strain:
- other: not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable (in vitro test)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µL bulk volume (about 20 mg) - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- not applicable (in vitro test)
- Number of animals:
- not applicable (in vitro test)
- Details on study design:
- Test system:
- In vitro test system on three dimensional human epidermis model. The EpiDermTM model consists of normal, human-derived epidermal keratinocytes cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
Material and technical equipment:
- EpiDerm™ 200 kit: MatTek Corp., Ashland MA, USA containing 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells® diameter 1 cm.
Controls:
- Negative control (NC): 50 µL of de-ionized water
- Positive control (PC): 8 N potassium hydroxide solution (Sigma-Aldrich, Munich, Germany)
Experimental procedure:
- First 25 µL de-ionized water was applied. Thereafter, a bulk volume of 25 µL of the solid test material was applied with a sharp spoon and homogeneously distributed with the water.
- After application of the test material to the stratum corneum surface of the EpiDermTM tissue the induced cytotoxicity (= loss of viability) is measured by a colourimetric assay.
- Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow coloured water soluble MTT to the insoluble blue coloured formazan. After isopropanol extraction of the formazan from the tissues, the optical densitiy of the extract is determined spectrophotometrically. Optical density of the extracts of test substance treated tissues is compared to negative control values and expressed as relative tissue viability.
Evaluation criteria:
- The test substance is considered as corrosive to the skin, if the mean relative tissue viability (% of negative control) after 3 min treatment is decreased below 50%.
- In addition, those materials with a viability of >= 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.
- Although the method is not finally validated for categorizing the severity of corrosion according to certain classification and labeling systems, it is suggested to use the most stringent category for test substances leading to viabilities below 50% after 3 min treatment.
Acceptance criteria:
In case one of the below given acceptance criteria is not covered, repetition of the test is considered.
- Assay acceptance criterion for the negative control (NC): The absolute OD570 of the negative control tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is >= 1.0. The mean OD570 of the NC should not exceed 2.5.
- Assay acceptance criterion for the positive control (PC): Potassium hydroxide as 8.0 N ready made solution is used as positive reference. A 3-minute treatment with 8.0 N KOH usually reveals a mean relative tissue viability of ~20%. An assay is acceptable if mean relative tissue viability of the 3 min positive control is <= 30%.
- Assay acceptance criterion for tissue variability: For every treatment, 2 tissues are treated in parallel. The inter-tissue variability is considered to be acceptable if the difference of the OD570 values of the two tissues is <= 0.3.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: viability (%)
- Value:
- 85
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 min. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Corrosion in vitro test. (migrated information)
- Irritation / corrosion parameter:
- other: other: viability (%)
- Value:
- 13
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Corrosion in vitro test. (migrated information)
In vivo
- Irritant / corrosive response data:
- The test substance is not able to reduce MTT directly.
- Viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 85%.
- Viability of the test-substance treated tissues determined after an exposure period of 1 hour was 13%.
Any other information on results incl. tables
Table 2: Corrosion test
Test substance |
Expsosure: 3 min |
Exposure: 1 hour |
|||||
Tissue 1 |
Tissue 2 |
Mean |
Tissue 1 |
Tissue 2 |
Mean |
||
NC |
Mean OD570 |
1.918 |
1.922 |
1.920 |
1.930 |
1.774 |
1.852 |
Viability (% of NC) |
99.9 |
100.1 |
100 |
104.2 |
95.8 |
100 |
|
Test Substance |
Mean OD570 |
1.708 |
1.569 |
1.639 |
0.244 |
0.244 |
0.244 |
Viability (% of NC) |
89.0 |
81.7 |
85 |
13.2 |
13.2 |
13 |
|
PC |
Mean OD570 |
0.399 |
0.293 |
0.346 |
0.166 |
0.217 |
0.192 |
Viability (% of NC) |
20.8 |
15.2 |
18 |
9.0 |
11.7 |
10 |
NC: Negative control (De-ionized water)
PC: Positive control (8 N potassium hydroxide solution)
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the observed results and applying the evaluation criteria, it was concluded, that the test substance shows a corrosion potential in the EpiDerm™ skin corrosion test under the test conditions chosen.
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