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EC number: 838-724-1 | CAS number: 94568-76-0
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 - 15 Dec 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted 26 Jun 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Justiz und Verbraucherschutz
Test material
- Reference substance name:
- 1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine
- EC Number:
- 838-724-1
- Cas Number:
- 94568-76-0
- Molecular formula:
- C12H17N
- IUPAC Name:
- 1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: obtained from slaughterhouse (Otto Vollertsen GmbH, Mittelangeln, Germany)
- Characteristics of donor animals: 6 - 12 months old; no further characteristics given in the report
- Storage, temperature and transport conditions of ocular tissue: On collection, the eyes were completely submerged in Hanks´ Balanced Salt Solution (HBSS). No further transport conditions given in the report.
- Indication of any existing defects or lesions in ocular tissue samples: no; only corneas from eyes free of defects were used
- Indication of any antibiotics used: yes, penicillin at 100 IU/mL and streptomycin at 100 µg/mL
SELECTION AND PREPARATION OF CORNEAS
The corneas were dissected with a 2 to 3 mm rim of sclera and mounted in corneal holders with anterior (epithelium) and posterior (endothelium) chambers.
QUALITY CHECK OF THE ISOLATED CORNEAS
At the end of the equilibration period, the basal opacity was determined (t0). Corneas that had opacity greater than seven opacity units or equivalent for the opacitometer and cornea holders used after an initial one-hour equilibration period had to be discarded. A minimum of three corneas with opacity values close to the median value for all corneas were selected as negative control corneas. The remaining corneas were then distributed into treatment and positive control groups.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL (also for neg. and pos. controls) - Duration of treatment / exposure:
- 10 min
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- 2 hours at 32°C ± 1°C
- Number of animals or in vitro replicates:
- triplicates for each treatment and control group
- Details on study design:
- TREATMENT METHOD: Open-Chamber method: Beginning with the posterior chambers, the chambers were filled to excess with pre-warmed Eagle's Minimum Essential Medium (EMEM), while preventing bubble formation. The corneal holder was equilibrated at 32°C ± 1°C for at least one hour. The glass window from the anterior chamber was removed prior to treatment. The controls or test substance were applied directly to the epithelial surface of the cornea using a pipet. After the exposure period of 10 minutes the exposition solution, namely the test item, the negative and positive controls, were removed from the chamber.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least 3. The epithelium was washed with EMEM containing phenol red. Washing was repeated (at least two times) until no test item or discolouration of phenol red was visible. The corneas were rinsed a final time with EMEM without phenol red only to remove any remaining phenol red from the chamber.
POST-EXPOSURE INCUBATION:
The corneas were incubated at 32 ± 1°C for two hours.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea measured quantitatively via an opacitometer (BASF OP-3.0, Ludwigshafen am Rhein, Germany) resulting in opacity values measured on a continuous scale.
- Corneal permeability: passage of sodium fluorescein dye measured quantitatively with the aid of a microfilter plate reader (Tecan infinite 200Pro, Tecan Deutschland GmbH, Crailsheim, Germany). Measurements at 490 nm were recorded as optical density (OD490).
SCORING SYSTEM:
In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
Test substance with an IVIS > 55 was regarded as serious eye damage and labelled Category 1 according to CLP and GHS-UN, respectively.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
Test substance with an IVIS > 3; ≤ 55 no prediction can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean value of 3 corneas
- Run / experiment:
- 10 min exposure
- Value:
- 1.84
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
-Visible damage on test system: not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the negative control resulted in opacity (-0.053 ± 0.564) and permeability (0.025 ± 0.016) values that were less than the established upper limits for background opacity and permeability values for bovine corneas treated with the respective negative control (see 'any other information on results incl. tables', table 1).
- Acceptance criteria met for positive control: Yes, the positive control resulted in an IVIS (87.426 ± 18.762) which was within two standard deviations of the current historical mean and well above the cut-off value of 55.
HISTORICAL CONTROL DATA
See ''any other information on results incl. tables', table 4'
Any other information on results incl. tables
Table 1: Opacity values and corrected opacity values of the BCOP assay.
Parameter | Opacity [Opacity Units] | Corrected Opacity | ||
After subtraction of the background opacity (neg. ctrl. = 0.053) | Mean of group | Standard deviation | ||
Negative control (0.9% NaCl) | 0.597 | - | -0.053 | 0.564 |
-0.358 | ||||
-0.399 | ||||
Test substance | 2.112 | 2.165 | 1.275 | 1.039 |
0.080 | 0.133 | |||
1.475 | 1.528 | |||
Positive control (1% NaOH) | 62.151 | 62.204 | 46.321 | 13.916 |
40.438 | 40.491 | |||
36.216 | 36.269 |
Table 2: Permeability OD values (490 nm) of the BCOP assay.
Parameter | Permeability [OD] | Mean of Triplicates | Corrected Permeability [OD] | ||||
After subtraction of the background permeability (neg. ctrl. = 0.025) | Per Cornea | Per Group | |||||
Mean | SD | Mean | SD | ||||
Negative control (0.9% NaCl) | 0.020 | 0.020 | - | 0.020 | 0.001 | 0.025 | 0.016 |
0.020 | - | ||||||
0.019 | - | ||||||
0.044 | 0.043 | - | 0.043 | 0.001 | |||
0.043 | - | ||||||
0.042 | - | ||||||
0.012 | 0.013 | - | 0.013 | 0.001 | |||
0.013 | - | ||||||
0.013 | - | ||||||
Test substance | 0.036 | 0.036 | 0.011 | 0.011 | 0.000 | 0.038 | 0.029 |
0.036 | 0.011 | ||||||
0.036 | 0.011 | ||||||
0.058 | 0.058 | 0.033 | 0.033 | 0.000 | |||
0.058 | 0.033 | ||||||
0.058 | 0.033 | ||||||
0.094 | 0.094 | 0.069 | 0.069 | 0.001 | |||
0.094 | 0.069 | ||||||
0.095 | 0.070 | ||||||
Positive control (1% NaOH) | 2.875 | 2.897 | 2.850 | 2.872 | 0.026 | 2.740 | 0.579 |
2.925 | 2.900 | ||||||
2.890 | 2.865 | ||||||
3.280 |
3.267
| 3.255 | 3.242 | 0.013 | |||
3.265 | 3.240 | ||||||
3.255 | 3.230 | ||||||
2.145 | 2.132 | 2.120 | 2.107 | 0.013 | |||
2.120 | 2.095 | ||||||
2.130 | 2.105 |
Table 3: In-Vitro Irritancy Score (IVIS) values of the BCOP assay.
Parameter | Per Cornea | Per Group | |
Mean | SD | ||
Negative control (0.9% NaCl) | 0.897 | 0.327 | 0.552 |
0.287 | |||
-0.204 | |||
Test substance | 2.330 | 1.840 | 1.056 |
0.628 | |||
2.563 | |||
Positive control (1% NaOH) | 105.284 | 87.426 | 18.762 |
89.121 | |||
67.874 |
Table 4: Historical Control Data of the BCOP assay with liquid test items (2017 to 2020 (n=18)).
| Parameter | Mean |
SD
| Lower limit of acceptance (mean – 2x SD) | Upper limit of acceptance (mean + 2x SD) |
NaCl 0.9 % | Opacity | -0.083 | 0.844 | -1.771 | 1.604 |
Permeability | 0.009 | 0.008 | -0.007 | 0.025 | |
IVIS | 0.053 | 0.830 | -1.608 | 1.713 | |
NaOH 1% | Opacity | 58.768 | 14.710 | 29.349 | 88.188 |
Permeability | 2.329 | 0.896 | 0.537 | 4.121 | |
IVIS | 93.702 | 18.606 | 56.489 | 130.914 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Irrit. 2 (H319) according to Regulation (EC) No 1272/2008
- Conclusions:
- This study was part of an integrated testing strategy. A bottom-up approach starting with the Epiocular™ test (according to OECD 492) was conducted. A positive in vitro irritation response was revealed for the test substance, which is not conclusive with respect to classification of the test substance as eye irritant (Eye Irritant Cat. 2) or serious eye damage (Eye Damage Cat. 1). Therefore, the BCOP was chosen as follow-up test (according to OECD 437) and, as already described, the test substance turned out not to be irritating. It is therefore concluded that the test substance 1,1,3-trimethylindan-4-amine should be classified as Eye Irrit. Cat. 2 according to Regulation (EC) No 1272/2008.
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