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EC number: 267-104-8 | CAS number: 67800-80-0
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24/05/2018 - 5/12/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl 2-[(2-methylundecylidene)amino]benzoate
- EC Number:
- 267-104-8
- EC Name:
- Methyl 2-[(2-methylundecylidene)amino]benzoate
- Cas Number:
- 67800-80-0
- Molecular formula:
- C20H31NO2
- IUPAC Name:
- methyl 2-[(2-methylundecylidene)amino]benzoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- CAS No. 67800-80-0
EINECS-No. 267-104-8
Solubility H2O: <0.1g/L; EtOH: >1g/L; acetone: >1g/L; CH3CN:
>1g/L
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL , undiluted
- Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 hours
Permeation: + 90 min - Number of animals or in vitro replicates:
- 3
- Details on study design:
- EVALUATION
- Calculation of Opacity
The change of opacity value of each treated cornea with test item, positive control and negative control was calculated by subtracting the initial basal opacity from the post treat- ment opacity reading for each cornea.
The average change in opacity of the negative control cornea was calculated and this val- ue was subtracted from the change in opacity of each treated cornea with test item and positive control to obtain a corrected opacity.
Opacity = [(I0/I)-b]/a
a = 0.0251 and b = 0.9894 being Opacitometer-specific empirically determined variables I0 = the empirically determined illuminance through a cornea holder with windows and Medium, here: Io= 1096.80
I = the measured illuminance (unit: LUX)
- Calculation of Permeability
The corrected OD492 value of each cornea treated with test item and positive control was calculated by subtracting the mean negative control cornea value from the original perme- ability value for each cornea.
The mean OD492 value for each treatment group (test item, positive control and negative control) was determined by averaging the final corrected OD492 values of the treated cor- neas for one treatment group.
- Calculation of IVIS (In Vitro Irritancy Score)
The IVIS of each replicate of the negative control was calculated from the following equa- tion:
IVIS = opacity difference + (15 x corrected OD492 value)
The IVIS of each replicate of the positive control and of the test item were calculated from the following equation:
IVIS = (opacity difference – mean opacity difference of the negative control) + [15 x (OD492
– mean OD492 of the negative control)]
Note: All calculations are performed with unrounded values. Therefore, re-calculation with rounded values may lead to slightly different results.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main
- Value:
- ca. -0.18
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 1.34
- Positive controls validity:
- valid
- Remarks:
- 120.36
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD Guideline no. 437 (Oct. 2017), Methyl 2-[(2- methylundecylidene)amino]benzoate requires no classification for eye irritation or serious eye damage under GHS.
- Executive summary:
This in vitrostudy was performed to assess corneal damage potential of Methyl 2-[(2- methylundecylidene)amino]benzoate by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test item Methyl 2-[(2-methylundecylidene)amino]benzoate was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post- incubation, opacity and permeability values were measured.
The test item was tested neat. Under the conditions of this test, the test item Methyl 2-[(2 - methylundecylidene)amino]benzoate showed no effects on the cornea of the bovine eye. The calculated IVIS is -0.18.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
The negative control (HBSS) and the positive control (undiluted dimethylformamide) have met the validity criteria.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
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