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EC number: 943-406-1 | CAS number: -
- 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:
- supporting study
- Study period:
- 26 Jan 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- (adopted July 26, 2013)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(N-methyldodecanamido)acetic acid 2-hydroxypropan-1-aminium 2-(N-methyldodecanamido)acetate
- EC Number:
- 943-406-1
- Molecular formula:
- Not applicable. This substance is UVCB.
- IUPAC Name:
- 2-(N-methyldodecanamido)acetic acid 2-hydroxypropan-1-aminium 2-(N-methyldodecanamido)acetate
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): MIPA-Cocoyl-Sarkosinat
- Substance type: organic (UVCB)
- Physical state: clear yellow-brown viscous liquid
- Analytical purity: 100%, according to definition of UVCB
- Impurities (identity and concentrations): no impurities, UVCB
- Composition of test material, percentage of components: 100% MIPA-Cocoyl-Sarkosinat
- Lot/batch No.: 070715
- Expiration date of the lot/batch: 31 Dec 2016
- Stability under test conditions: stable in vehicle water
- Storage condition of test material: at room temperature
- Other: pH 5.7 - 6.0 (1% in water)
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Not applicable, in vitro test performed with bovine eyes as soon as possible after slaughter.
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. The eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- physiological saline
- Controls:
- other: yes, 3 corneas concurrently treated with vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 750 µL of a 10% dilution (since test item is a surfactant)
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL physiological saline - Duration of treatment / exposure:
- 10 ± 1 minutes
- Observation period (in vivo):
- Opacity determination after 120 ± 10 minutes incubation time, followed by permeability measurement
- Number of animals or in vitro replicates:
- 3 isolated corneas per treatment group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with MEM with phenol red (Eagle's Minimum Essential Medium, Life Technologies), thereafter with phenol red free cMEM
- Time after start of exposure: 10 ± 1 min
SCORING SYSTEM: not applicable; opacity measurement, followed by permeability determination
TOOL USED TO ASSESS SCORE: opacity measured with device OP-KIT; permeability determined by measurement of optical density of medium of posterior compartment of cornea holder at 490 nm (OD490) in a microplate reader (TECAN Infinite M200 Pro Plate Reader) after incubation of cornea for 90 ± 5 minutes at 32 ± 1 °C to 1 mL of 4mg sodium-fluorescein/mL phenol red free cMEM in anterior compartment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Mean In vitro irritancy score (IVIS)
- Basis:
- mean
- Remarks:
- of 3 corneas
- Time point:
- other: 10 ± 1 min
- Score:
- -0.6
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Negative control
- Irritation parameter:
- other: Mean In vitro irritancy score (IVIS)
- Basis:
- mean
- Remarks:
- of 3 corneas
- Time point:
- other: 10 ± 1 min
- Score:
- 140.5
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Positive control (10% Benzalkonium chloride)
- Irritation parameter:
- other: Mean In vitro irritancy score (IVIS)
- Basis:
- mean
- Remarks:
- of 3 corneas
- Time point:
- other: 10 ± 1 min
- Score:
- 19.3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 10% Test substance
- Irritant / corrosive response data:
- The corneas treated with the test substance showed opacity values ranging from 5.5 to 6.3 and permeability values ranging from 0.807 to 0.981. The corneas were slightly translucent after the 10 minutes of treatment with test substance. A pH effect of the test item was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed. Hence, the in vitro irritancy scores ranged from 18 to 20 after 10 minutes of treatment with test substance.
Any other information on results incl. tables
The test substance induced ocular irritation through both endpoints, opacity and permeability, resulting in a mean in vitro irritancy score of 19 after 10 minutes of treatment.
Since the test substance induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
Summary of opacity, permeability and in vitro scores
Treatment |
Mean Opacity1 |
Mean Permeability1 |
Mean In vitro Irritation Score1, 2 |
Negative control |
-0.4 |
-0.014 |
-0.6 |
Positive control (Benzalkonium Chloride) |
93.1 |
3.159 |
140.5 |
Test substance |
5.9 |
0.896 |
19.3 |
1 Calculated by subtracting the negative control mean opacity and mean permeability values from those for the positive control and test item.
2 Mean In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD 490 value).
Opacity score
Treatment |
Opacity before treatment |
Opacity after treatment |
Final Opacity1 |
Negative control corrected Final Opacity2, 3 |
Mean Final Opacity |
Negative control |
3.0 |
2.5 |
-0.6 |
|
-0.4 |
2.9 |
3.6 |
0.8 |
|||
3.5 |
2.0 |
-1.5 |
|||
Positive control |
3.6 |
105.3 |
101.7 |
101.7 |
93.1 |
3.3 |
93.5 |
90.2 |
90.2 |
||
2.5 |
89.9 |
87.5 |
87.5 |
||
Test substance |
3.4 |
8.9 |
5.5 |
5.5 |
5.9 |
3.0 |
9.4 |
6.3 |
6.3 |
||
3.1 |
8.9 |
5.8 |
5.8 |
1 Final Opacity = Opacity after treatment – Opacity before treatment.
2 Negative control corrected Final Opacity = Final Opacity – Mean final opacity negative control.
3 In case the mean final opacity of the negative control is below zero, no correction was made.
Permeability score individual values (corrected)
Treatment |
Dilution factor |
Negative control corrected OD490 11 |
Negative control corrected OD490 21 |
Negative control corrected OD490 31 |
Negative control corrected OD490 Average |
Negative control corrected final OD490 |
Average OD |
Positive control |
6 |
0.604 |
0.595 |
0.599 |
0.599 |
3.596 |
3.159 |
6 |
0.483 |
0.481 |
0.481 |
0.482 |
2.890 |
||
6 |
0.503 |
0.494 |
0.498 |
0.498 |
2.990 |
||
Test substance |
1 |
0.973 |
0.980 |
0.989 |
0.981 |
0.981 |
0.896 |
1 |
0.896 |
0.899 |
0.909 |
0.901 |
0.901 |
||
1 |
0.810 |
0.798 |
0.814 |
0.807 |
0.807 |
1 OD490 values corrected for the mean final negative control permeability (-0.014).
Applicant's summary and conclusion
- Interpretation of results:
- other: no classification possible
- Remarks:
- Criteria used for interpretation of results: OECD GHS
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