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EC number: 408-090-7 | CAS number: 100418-33-5 METHYLGELB
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- EC Number:
- 408-090-7
- EC Name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- Cas Number:
- 100418-33-5
- Molecular formula:
- C9H12N2O3
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)amino]ethan-1-ol
- Test material form:
- solid: crystalline
- Details on test material:
- orange powder
Batch # : 7215587794
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg of the test item (83.3 mg/cm² according to guideline)
- Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % tissue viability
- Remarks:
- % of negative control
- Run / experiment:
- 6 hours
- Value:
- 3.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Results after treatment for 6 hours withHydroxyethyl-2-Nitro-p-Toluidine (B075)and the controls
Dose Group |
Ab-sorbance |
Ab-sorbance |
Mean Absor-bance (Tissue 1/2) |
Mean Absorbance Tissue 1 and 2 minus Mean Blank |
Mean Absorbance of |
Rel. Absorbance [%] |
Absolute Value of the Difference of the Rel. Absorbances [%] |
Mean Rel. Absorbance [% of Negative Control]* |
|
0.038 |
0.038 |
0.038 |
0.000 |
|
|||
Negative Control |
1.742 |
1.751 |
1.747 |
1.709 |
1.703 |
100.3 |
0.7 |
100.0 |
1.767 |
1.703 |
1.735 |
1.697 |
99.7 |
||||
Positive Control |
0.340 |
0.363 |
0.351 |
0.313 |
0.303 |
18.4 |
1.2 |
17.8 |
0.332 |
0.331 |
0.332 |
0.293 |
17.2 |
||||
Test Item |
0.096 |
0.094 |
0.095 |
0.056 |
0.059 |
3.3 |
0.3 |
3.5 |
0.100 |
0.101 |
0.100 |
0.062 |
3.6 |
||||
Blank |
0.038 |
0.038 |
0.038 |
0.000 |
|
|||
Negative Control |
0.041 |
0.040 |
0.040 |
0.003 |
0.003 |
0.1 |
0.0 |
0.2 |
0.041 |
0.041 |
0.041 |
0.003 |
0.2 |
||||
Test Item |
0.039 |
0.039 |
0.039 |
0.001 |
0.001 |
0.1 |
0.0 |
0.0 |
0.039 |
0.039 |
0.039 |
0.001 |
0.0 |
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water or isopropanol led to a change in colour. Therefore, an additional test with viable tissues without MTT addition was necessary. Optical evaluation of the MTT-reducing capacity of the test item with MTT-reagent did not showed blue colour. Therefore, an additional test with freeze-killed tissues was not necessary. The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 3.5% (threshold for irritancy:≤60%), consequently the test item was irritant to eye. Since the test item proved to be clearly eye irritant, correction of the viability using the determined correction factors derived from the additional tests was not necessary.
Concerning acceptance criteria:
· The mean negative control OD (blank corrected) is > 0.8 and < 2.5(1.703 and 1.697).
· The mean relative viability of the positive control is below 50% of the negative control viability (17.8%).
The difference of viability between the two relating tissues of a single item is < 20% (values between 0.0% and 1.2%) in the same run (for positive and negative control tissues and tissues of single test items).This applies also to theadditional viable tissues (without MTT addition), which were calculated as percent values related to the viability of the relating negative control.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, Hydroxyethyl-2-Nitro-p-Toluidine (B075) possesses an eye irritating potential.
- Executive summary:
This in vitro study was performed to assess the eye irritation potential of Hydroxyethyl-2-Nitro-p-Toluidine (B075) by means of the Human Cornea Model Test. The test item did not prove to be an MTT reducer in the MTT pre-test, but it changed colour in the presence of water (reddish) and isopropanol (orange) in the colour interference pre-test. Therefore, an additional test with freeze-killed tissues did not have to be performed, but an additional test with viable tissues (without MTT addition) was necessary to determine a correction factor for calculating the true viability in the main experiment. Each 50 mg of the test item, were applied to each of duplicate tissue for 6 hours. Each 50 µL of the negative control (deionised water) and of the positive control (methyl acetate) were also applied to duplicate tissues each.After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD > 0.8 and < 2.5 thus showing the quality of the tissues. Treatment with the positive control induced a decrease below 50% compared with thenegative control value in the relative absorbance thus ensuring the validity of the test system. The difference of viability between the two relating tissues was < 20% in the same run (for test item tissues, positive and negative control tissues). Irritating effects were observed following incubation with Hydroxyethyl-2-Nitro-p-Toluidine (B075). Compared with the value of the negative control the relative mean absorption value corresponding to the viability of the tissues decreased to 3.5% (threshold for irritancy: < 60%). Since the test item was classified as irritant in the main experiment due to a viability being lower than the cut-off of 60%, it was not necessary to correct the viability value in the main experiment with the determined correction factor. In conclusion, it can be stated that in this study and under the experimental conditions reported, Hydroxyethyl-2-Nitro-p-Toluidine (B075) possesses an eye irritating potential.
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