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EC number: 220-638-5 | CAS number: 2842-44-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(N-methyl-p-toluidino)ethanol
- EC Number:
- 220-638-5
- EC Name:
- 2-(N-methyl-p-toluidino)ethanol
- Cas Number:
- 2842-44-6
- Molecular formula:
- C10H15NO
- IUPAC Name:
- 2-[methyl(4-methylphenyl)amino]ethan-1-ol
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- The test item is a liquid non-surfactant substance. It was tested directly, without dilution or preparation of a solution.
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bos primigenius Taurus (fresh bovine corneas)
- 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 and 10 minutes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL of test item
- Duration of treatment / exposure:
- 10 minutes at 32 ± 1 °C.
- Observation period (in vivo):
- 3,5 hours at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 2 hours at 32 ± 1 °C
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- 21.61
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
1.1 Opacity and Permeability Values
Theilluminance (unit: LUX) values which were measured before and after exposure are given in the following table:
Table 9.1‑a Illuminance Values
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
1059 |
1044 |
1022 |
1032 |
1013 |
1009 |
998 |
1024 |
998 |
(I) Measured values after exposure |
1040 |
1013 |
1032 |
1034 |
1012 |
1008 |
282 |
282 |
272 |
Rep. = Replicate
The values in the following tables present the calculated opacity values, according to evaluation (see chapter 8.1):
Table 9.1‑b Opacity Values Negative Control
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
1.53 |
2.12 |
3.01 |
Opacity after exposure |
2.27 |
3.39 |
2.60 |
Opacity Difference |
0.75 |
1.27 |
-0.41 |
Mean Opacity Difference |
0.54 |
Rep. = Replicate
Table 9.1‑c Opacity Values Test Item and Positive Control
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
1.92 |
4.12 |
2.97 |
4.03 |
2.93 |
4.03 |
Opacity |
13.46 |
17.41 |
16.17 |
114.34 |
114.34 |
120.00 |
Opacity |
11.54 |
13.29 |
13.20 |
110.31 |
111.42 |
115.97 |
Opacity corrected |
11.01 |
12.76 |
12.67 |
109.78 |
110.88 |
115.43 |
Mean Opacity corrected |
12.15 |
112.03 |
Rep. = Replicate
For the permeability measurement, three replicates for each treatment group were measured three times. cMEM without phenol red was measured as blank value as well. The optical density values at 492 nm are given in the following tables:
Table 9.1‑d Optical density at 492 nm of Blank
Parameter |
cMEM without phenol red |
1. Measurement |
0.032 |
2. Measurement |
0.036 |
3. Measurement |
0.033 |
Mean |
0.034 |
Table9.1‑e Optical density at 492 nm of Negative Control, Test Item and Positive Control
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
1. Measure-ment |
0.044 |
0.043 |
0.043 |
0.481 |
0.479 |
1.057 |
1.520 |
2.009 |
0.848 |
2. Measure-ment |
0.043 |
0.039 |
0.037 |
0.478 |
0.482 |
1.046 |
1.525 |
2.025 |
0.839 |
3. Measure-ment |
0.045 |
0.039 |
0.039 |
0.483 |
0.475 |
1.071 |
1.534 |
2.061 |
0.840 |
|
|||||||||
1. Measure-ment – blank |
0.0103 |
0.0093 |
0.0093 |
0.4473 |
0.4453 |
1.0233 |
1.4863 |
1.9753 |
0.8143 |
2. Measure-ment – blank |
0.0093 |
0.0053 |
0.0033 |
0.4443 |
0.4483 |
1.0123 |
1.4913 |
1.9913 |
0.8053 |
3. Measure-ment – blank |
0.0113 |
0.0053 |
0.0053 |
0.4493 |
0.4413 |
1.0373 |
1.5003 |
2.0273 |
0.8063 |
Mean of each replicate |
0.0103 |
0.0067 |
0.0060 |
0.4470 |
0.4450 |
1.0243 |
1.4927 |
1.9980 |
0.8087 |
Mean of the 3 replicates |
0.0077 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
0.4393 |
0.4373 |
1.0167 |
1.4850 |
1.9903 |
0.8010 |
Corrected mean of the 3 replicates |
-- |
0.6311 |
1.4254 |
Rep. = Replicate
1.2 IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table9.2‑a IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.90 |
0.65 |
134.22%* |
1.37 |
|||
- 0.32 |
|||
Test Item |
17.60 |
21.61 |
25.59% |
19.32 |
|||
27.92 |
|||
Positive Control |
132.05 |
133.41 |
5.06% |
140.74 |
|||
127.45 |
*Note: the high relative standard deviation of the IVIS of the negative control is due to mathematical reasons, as the respective means are very small.
1.3 Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The mean IVIS of the negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given in the following table:
Table9.3‑a Validity
Parameter |
Criterion |
Found |
Assessment |
Mean IVIS of negative control HBSS |
≤3 |
0.65 |
ok |
Mean IVIS of positive control |
53.18 - 138.89 |
133.41 |
ok |
The mean IVIS values for negative and positive controls were within the range of historical data of the test facility (see Annex 2, page22). Therefore, the test system was acceptable.
1.4 Assessment
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made.
Table9.4‑a Classification Scheme
IVIS |
UN GHS |
≤ 3 |
No category |
> 3 and≤ 55 |
No prediction can be made |
> 55 |
Eye damage Category I |
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
The test item N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) showed effects on the cornea of the bovine eye. The calculated mean IVIS was 21.61.
The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- This in vitro study was performed to assess corneal damage potential of N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) by quantitative measurements of changes in opacity and permeability in a bovine cornea. The test item N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) 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 N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) showed effects on the cornea of the bovine eye. The calculated mean IVIS was 21.61. According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made. 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.
- Executive summary:
One valid experiment was performed. Bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old. The test item N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) was applied onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.
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. Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irritancy Score) was 0.65. Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated mean IVIS was 133.41.
Under the conditions of this study, the test itemN-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT)showed effects on the cornea of the bovine eye. The calculated mean IVIS was 21.61.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage with the BCOP study only. In this case no prediction can be made.
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