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EC number: 926-195-0 | CAS number: 1176284-65-3
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- 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)
- Deviations:
- yes
- Remarks:
- minor. The test item was stored at 25.9 deg C for 8.5 h, rather than at 20 deg C as stated in the protocol. Also,the measurement of opacity was done in a photometer rather than an opacitometer, but an appropriate calculation can be made for correction.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Addition product of maleic anhydride, tall oil fatty acids, linseed oil and methanol
- Molecular formula:
- not available for the UVCB substance
- IUPAC Name:
- Addition product of maleic anhydride, tall oil fatty acids, linseed oil and methanol
- Test material form:
- liquid
- Details on test material:
- Name ZWA 5496/100
Batch no. 210150084
Appearance brown liquid
Composition Reaction products of maleic anhydride (MA), disproportionated tall oil fatty acid, linseed oil andmethanol
Molecular weight 380-1400 g/mol
Purity 100% (UVCB
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bos primagenius Taurus
- Details on test animals or tissues and environmental conditions:
- Bovine corneas were used from previously slaughtered cattle which were between ages 12-60 months. SOURCE OF COLLECTED EYES
- Source:
- Number of animals:
- Characteristics of donor animals (e.g. age, sex, weight): age 12-60 months, M/F,
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):
- Time interval prior to initiating testing:
- indication of any existing defects or lesions in ocular tissue samples: eyes checked for defects as part of the selection criteria
- Indication of any antibiotics used:
TEST ANIMALS
- Source: Muller Fleisch GmbH,Birkenfeld, Germany. Isolated fresh.
- Age at study initiation:12-60 months
- Weight at study initiation: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): After receipt, incubated 1 h at 32 deg C in Hank's Balanced Salt Solution in exposure chambers. Vessels were sterilized glass or sterilizable plastic.
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: 2 Sept. 2015
Test system
- Vehicle:
- other: Minimal Essential Medium (MEM) without penol but supplemented with sodium bicarbinate, L-glutamine and 10% fetal calf serum (FCS).
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- no
- Amount / concentration applied:
- 750 μL
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- Bovine eyes ex vivo were used in the study.
- Details on study design:
- Light transmission was recorded through each cornea in a spectrophotomer at 570 nm, prior to exposure. This comprised the baseline opacity.
Three replicate measurements were obtained.
The closed chamber method was used. The respective substance (negative control solution, test item or positive control) was applied by pipetting 750 μL of the appropriate liquid through the refill hole in the holder of the cornea. The test item was applied to the epithelium in such a manner that as much as possible of the cornea was covered with the test item.
Exposure time was 10 min at 32 ± 1 °C. After rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 h at 32 ± 1 °C (post-incubation). The cMEM without phenol red was renewed in both chambers of the apparatus. Then, the final opacity value of each cornea was recorded (again by measurement at 570 nm).
The cMEM without phenol red was removed from the front chamber, and 1 mL sodium fluorescein solution (concentration: 4 mg/mL) was added to the front chamber. The chambers were then closed and incubated for 90 min at 32 ± 1 °C. After incubation, the content of the posterior chamber was thoroughly mixed. Then, the permeability of the cornea was measured by reading the optical density at 490 nm of the liquid in the posterior chamber.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- 1.83
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Mean opacity difference of the negative control is 0.1220.
For the test item, the calculated IVIS (In vitro irritancy scoe) is 1.83. The experiment is considered as sufficient for the classification of the test item because two of the three replicates of the test item lead to the same assessment for the test item.
Any other information on results incl. tables
Optical Density of the test substance:
Replicate |
Negative Control |
Test Item ZWA 5496/100 |
Positive Control |
||||||
Measured values |
-0.0004 |
0.0007 |
0.0031 |
0.0060 |
0.0413 |
0.0240 |
0.1997 |
0.2629 |
0.2637 |
*Corrected values |
-0.0020 |
0.0035 |
0.0155 |
0.0300 |
0.2065 |
0.1200 |
0.9985 |
1.3145 |
1.3185 |
Mean |
0.0057 |
Absorbance and Opacity Values of the Negative Control:
Parameter |
Negative Control |
||
Absorbance before exposition |
0.1888 |
0.1907 |
0.1792 |
Absorbance after exposition |
0.2395 |
0.2033 |
0.2148 |
Opacity before exposition |
1.5445 |
1.5513 |
1.5108 |
Opacity after exposition |
1.7358 |
1.5970 |
1.6398 |
Opacity Difference |
0.1913 |
0.0457 |
0.1291 |
Absorbance and Opacity Values for the Test Item and the Positive Control:
Parameter |
Test Item ZWA 5496/100 |
Positive Control |
||||
Absorbance before exposition |
0.1297 |
0.2813 |
0.1462 |
0.1425 |
0.1296 |
0.1766 |
Absorbance af- ter exposition |
0.1560 |
0.3495 |
0.2432 |
1.9991 |
1.8398 |
1.9957 |
Opacity before exposition |
1.3480 |
1.9112 |
1.4002 |
1.3884 |
1.3477 |
1.5018 |
Opacity after exposition |
1.4322 |
2.2361 |
1.7507 |
99.7930 |
69.1512 |
99.0148 |
Opacity Difference |
0.0842 |
0.3250 |
0.3504 |
98.4046 |
67.8035 |
97.5130 |
In Vitro Irritancy Scores:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control 0.9% NaCl |
0.16 |
0.21 |
66.4% |
0.10 |
|||
0.36 |
|||
Test Item ZWA5496/100 |
0.33 |
1.83 |
79.2% |
3.22 |
|||
1.94 |
|||
Positive Control DMF undiluted |
113.18 |
105.86 |
15.3% |
87.31 |
|||
117.08 |
Note: the high relative standard deviations of the IVIS of test item and negative control are due to mathematical reasons, as the respective means are very small.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The calculated IVIS (in vitro irritancy score) of the undiluted test substance in the BCOP is 1.83. The criteria for a non-irritant (IVIS of 3 or less) is met and the substance is evaluated as not irritating to the eye.
- Executive summary:
less
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