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EC number: 202-903-7 | CAS number: 100-94-7
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- May - Aug 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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:
- 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt Rheinland-Pfalz
Test material
- Reference substance name:
- Dibenzyldimethylammonium chloride
- EC Number:
- 202-903-7
- EC Name:
- Dibenzyldimethylammonium chloride
- Cas Number:
- 100-94-7
- Molecular formula:
- C16H20N.Cl
- IUPAC Name:
- dibenzyldimethylammonium chloride
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: 17 Jan 2020
- Physical state / color: Solid / white
- pH value: Ca. 5 (undiluted test substance moistened with deionized water, determined in the lab prior to the start of the GLP study); Ca. 5 (20 % aqueous preparation; determined in the lab prior to start of the GLP study)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, under N2
- Solubility and stability of the test substance in the solvent/vehicle: After stirring with a magnetic stirrer, the test substance was soluble in the vehicle.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance preparation was produced on a weight per volume (w/v) basis shortly before application. After stirring with a magnetic stirrer, the test substance was soluble in the vehicle.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : 20 % (w/v) solution in deionized water
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Alzey, Emil Färber GmbH & Co. KG, Robert-Bosch-Straße 23, 55232 Alzey, Germany
- Characteristics of donor animals (e.g. age, sex, weight): min. 12 months and max. 60 months old animals
- indication of any existing defects or lesions in ocular tissue samples: Corneas free of defects (opacity, scratches, pigmentation etc.)
Test system
- Vehicle:
- water
- Remarks:
- deionized
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20 % (w/v) in deionized water
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 4 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consist of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagle’s MEM (without phenol red) and then equilibrated in a vertical position at about 32°C for at least 1 hour.
QUALITY CHECK OF THE ISOLATED CORNEAS : After the equilibration period, the medium in both chambers was replaced by fresh pre-warmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that showed macroscopic tissue damage or an opacity value < 561 opacity units were discarded. The remaining corneas were then distributed into negative control, positive control and treatment groups.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : deionized water
POSITIVE CONTROL USED : 20 % solution (w/v) of imidazole in deionized water
APPLICATION DOSE AND EXPOSURE TIME : 750 µL, 4 h
TREATMENT METHOD: [closed chamber / open chamber]
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: one
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Before measurement, each cornea was visually observed and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: see table 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1st experiment
- Value:
- 65
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2nd experiment
- Value:
- 45.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3rd experiment
- Value:
- 82.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Table 2: In Vitro Irritancy score (IVIS) of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
||
Per cornea |
Per group |
|||||
Mean |
SD |
|||||
Test substance |
7 8 9 |
63.9 42.8 73.5 |
0.078 0.171 0.584 |
65.0 45.3 82.3 |
64.2 |
18.5 |
NC |
1 2 3 |
2.8 9.8 8.5 |
0.004 0.005 0.008 |
2.9 9.9 8.6 |
7.1 |
3.7 |
PC |
4 5 6 |
91.0 96.7 88.8 |
1.606 2.043 2.389 |
115.1 127.3 124.6 |
122.4 |
6.4 |
Table 3: Opacity score of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Initial opacity |
Final opacity |
Opacity Change |
Corrected Opacity Change |
Mean |
SD |
Test substance |
7 8 9 |
6.5 5.2 6.5 |
77.4 55.0 87.1 |
70.9 49.8 80.5 |
63.9 42.8 73.5 |
60.0 |
15.7 |
NC |
1 2 3 |
6.9 6.0 6.4 |
9.7 15.8 14.9 |
2.8 9.8 8.5 |
NA NA NA |
7.0 |
3.7 |
PC |
4 5 6 |
4.9 6.6 5.6 |
103.0 110.3 101.4 |
98.1 103.7 95.8 |
91.0 96.7 88.8 |
92.2 |
4.1 |
Table 4: Permeability score of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Mean OD490 |
Dilution Factor |
Mean Corrected OD490 |
Mean |
SD |
Test substance |
7 8 9 |
0.084 0.176 0.590 |
1 1 1 |
0.078 0.171 0.584 |
0.278 |
0.270 |
NC |
1 2 3 |
0.004 0.006 0.008 |
1 1 1 |
NA NA NA |
0.006 |
0.002 |
PC |
4 5 6 |
0.322 0.410 0.479 |
5 5 5 |
1.606 2.043 2.389 |
2.013 |
0.393 |
Table 5: Historic control data of the BCOP Test
Historic Range of NC (protocol for solids) |
||||
Historic period |
||||
Jan 2017 – Mar 2019 (No. of tests performed: 12) |
||||
Opacity |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
9.2 |
3.7 |
16.5 |
1.9 |
|
Permeability (OD490) |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
0.003 |
0.002 |
0.006 |
0.000 |
|
In Vitro Irritation Score (IVIS) |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
9.2 |
3.7 |
16.6 |
1.9 |
|
Historic Range of PC (20 % Imidazole) |
||||
Historic period |
||||
Jan 2017 – Mar 2019 (No. of tests performed: 9) |
||||
Opacity |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
93.6 |
9.9 |
113.5 |
73.7 |
|
Permeability (OD490) |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
2.234 |
0.578 |
3.389 |
1.078 |
|
In Vitro Irritation Score (IVIS) |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
127.1 |
13.6 |
154.2 |
100.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In the BCOP Test the mean IVIS (64.2) of the corneas treated with the test substance indicated a serious eye irritation potential (BCOP cut-off threshold 55) of the test substance.
However, some variability between the results of the individual corneas treated with the test substance was noted and the mean IVIS lies minimal below the borderline range (IVIS 45.0 to 65.0) for evaluation.
Nevertheless, the result of the BCOP has to be considered to indivate ocular corrosion or severe irritation of the test substance, because the IVIS values of two corneas and the mean value of all corneas lie well above the BCOP cut-off threshold of 55 and the mean IVIS lies minimal below the upper value of the borderline range. - Executive summary:
The potential of the test substance to cause severe ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL 20% test-substance preparation to the epithelial surface of isolated bovine corneas.
Three corneas were treated with the test-substance preparation for an exposure period of 4 hours.
Besides the test substance, a negative control (NC; deionized water) and a positive control (PC; 20% imidazole in deionized water) were applied to three corneas each.
Corneal opacity was measured quantitatively as the amount of light transmitted through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance.
The mean IVIS (64.2) of the corneas treated with the 20% test substance preparation indicated serious eye damage (BCOP cut-off threshold 55) of the test substance.
The results of the test substance, the negative control (deionized water) and the positive control (20% imidazole) fulfilled the acceptance criteria and demonstrate the validity of the assay.
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