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EC number: 222-426-8 | CAS number: 3468-11-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.12.2016-01.03.2017
- 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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-imino-1H-isoindol-3-amine
- EC Number:
- 222-426-8
- EC Name:
- 1-imino-1H-isoindol-3-amine
- Cas Number:
- 3468-11-9
- Molecular formula:
- C8H7N3
- IUPAC Name:
- 1-imino-1H-isoindol-3-amine
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- - The EpiDerm™ tissue: normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Pre-incubation: the inserts containing the tissues were set into the incubator at 37 ± 1°C, 5.0% CO2 / 95% air for 1 hour.
- For each experiment (“3 minutes” and “1 hour”), the plates were stored in the incubator at 37 ± 1°C and 5.0 ± 0.5% CO2.
- MTT medium: the tissues were incubated with MTT medium for 3 h at 37 ± 1°C, 5.0% CO2 / 95% air. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg test item + 25 µL H2O
- Duration of treatment / exposure:
- 3 and 60 minutes treatment
- Number of replicates:
- 2 replicates for each treatment period (3 min and 60 min exposure time)
Test system
- Details on study design:
- Details of the test procedure
- EpiDerm™ tissue of human-derived epidermal keratinocytes was used (MatTek, EPI-200-SCT)
- Conditions of exposure: 37 ± 1 °C, 5% CO2
- Washing: the tissue was gently rinsed about 20 times with PBS
- Number of tissue replicates used per test chemical and controls: 2
- MTT assay: incubation with 0.3 mL of MTT solution for 3 hours at 37 ± 1 °C, 5% CO2)
- Data evaluation:
Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after 3 min and 60 min treatment compared to the negative control tissues concurrently treated with Aqua dest (= 100%) according to the following Prediction Model
In step 1:
< 50% after 3 min exposure: predicted as corrosive
≥ 50% after 3 min exposure AND < 15% after 60 min exposure: predicted as corrosive (a combin
ation of optional sub-categories 1B and 1C)
≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure: predicted as Non-Corrosive
In step 2:
< 25% after 3 min exposure: optional Sub-category 1A
≥ 25% after 3 min exposure: a combination of optional Sub-categories 1B and 1C
- Historical data negative control: Mean Absorption: 1.895 (3 min), 1.867 (1 h); Standard Deviation: 0.313 and 0.261, respectively
- Historical data positive control: Mean Viability: 6.1% (1 h); Standard Deviation: 1.99%
- The test meets acceptance criteria if:
- mean OD570 nm of the two negative control tissues of the 3 min and 60 min treatment period is between 0.8 and 2.8,
- mean relative tissue viability of the two positive control tissues of the 60 min treatment period is < 15%,
- coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min. incubation time
- Value:
- >= 87.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not corrosive to skin
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour incubation time
- Value:
- >= 17.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: borderline result
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour incubation time
- Value:
- >= 20.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: repeated due to a borderline result
- Remarks:
- no corrosive effects
- Other effects / acceptance of results:
- The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was≥ 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (5.4% and 10.7%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was ≤ 30% (2.8% - 13.3%).
Any other information on results incl. tables
Results of the 3 min experiment:
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
2.006 |
1.759 |
1.723 |
1.516 |
0.098 |
0.180 |
2.021 |
1.738 |
1.839 |
1.490 |
0.097 |
0.182 |
|
2.055 |
1.751 |
1.883 |
1.525 |
0.099 |
0.189 |
|
OD570- Blank Corrected |
1.963 |
1.715 |
1.680 |
1.473 |
0.055 |
0.137 |
1.977 |
1.695 |
1.796 |
1.447 |
0.054 |
0.139 |
|
2.011 |
1.708 |
1.840 |
1.482 |
0.056 |
0.146 |
|
Mean OD570of 3 Aliquots (blank corrected) |
1.984 |
1.706 |
1.772 |
1.467 |
0.055 |
0.141 |
SD OD570 of 3 Aliquots |
0.025 |
0.026 |
0.078 |
0.029 |
0.024 |
0.024 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.845 |
1.619 |
0.098 |
|||
TODTT |
- |
1.608 |
- |
|||
SD OD570 of 2 Replicate Tissues |
0.197 |
0.215 |
0.061 |
|||
Mean Relative Tissue |
100.0 |
87.8 |
5.3 |
|||
NSMTT-corrected mean relative tissue viability [%] |
- |
87.2 |
- |
|||
Coefficient Of Variation [%] |
10.7 |
13.3 |
62.2 |
Results of the 60 min experiment:
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.627 |
1.683 |
0.346 |
0.275 |
0.155 |
0.110 |
1.601 |
1.733 |
0.339 |
0.278 |
0.155 |
0.111 |
|
1.641 |
1.721 |
0.339 |
0.270 |
0.156 |
0.113 |
|
OD570- Blank Corrected |
1.582 |
1.638 |
0.302 |
0.230 |
0.110 |
0.065 |
1.556 |
1.688 |
0.294 |
0.233 |
0.110 |
0.066 |
|
1.596 |
1.676 |
0.294 |
0.226 |
0.111 |
0.068 |
|
Mean OD570of 3 Aliquots (blank corrected) |
1.578 |
1.667 |
0.296 |
0.230 |
0.111 |
0.066 |
SD OD570 of 3 Aliquots |
0.020 |
0.034 |
0.025 |
0.025 |
0.025 |
0.025 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.623 |
0.263 |
0.088 |
|||
TODTT |
- |
0.289 |
- |
|||
SD OD570 of 2 Replicate Tissues |
0.063 |
0.047 |
0.031 |
|||
Mean Relative Tissue |
100.0 |
16.2 |
5.4 |
|||
NSMTT-corrected mean relative tissue viability [%] |
- |
17.4 |
- |
|||
Coefficient Of Variation [%] |
3.9 |
17.9 |
35.5 |
Because of the borderline result, a second experiment was conducted.
Results of the second 60 min experiment:
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.644 |
1.707 |
0.329 |
0.393 |
0.209 |
0.229 |
1.700 |
1.672 |
0.352 |
0.400 |
0.213 |
0.228 |
|
1.826 |
1.598 |
0.351 |
0.383 |
0.213 |
0.232 |
|
OD570- Blank Corrected |
1.601 |
1.664 |
0.285 |
0.349 |
0.166 |
0.185 |
1.657 |
1.628 |
0.309 |
0.357 |
0.169 |
0.184 |
|
1.783 |
1.554 |
0.308 |
0.340 |
0.169 |
0.189 |
|
Mean OD570of 3 Aliquots (blank corrected) |
1.680 |
1.616 |
0.301 |
0.349 |
0.168 |
0.186 |
SD OD570 of 3 Aliquots |
0.093 |
0.055 |
0.027 |
0.025 |
0.024 |
0.024 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.648 |
0.325 |
0.177 |
|||
TODTT |
- |
0.351 |
- |
|||
SD OD570 of 2 Replicate Tissues |
0.046 |
0.034 |
0.013 |
|||
Mean Relative Tissue |
100.0 |
19.7 |
10.7 |
|||
NSMTT-corrected mean relative tissue viability [%] |
- |
20.9 |
- |
|||
Coefficient Of Variation [%] |
2.8 |
10.4 |
7.2 |
Applicant's summary and conclusion
- Conclusions:
- The test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Executive summary:
In an in vitro study, the skin corrosion potential of the test item was assessed with the Reconstructed Human Epidermis (RhE)
test method according to OECD 431 and EU-Method B.40 and in compliance to GLP.
The test item was applied topically and cytotoxic effects to the stratum corneum after a short time exposure were determined. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item showed non-specific MTT-reducing (NSMTT) potential. Therefore, additional killed tissue controls were treated with the test item to determine the non-specific reduction of MTT. After 3 min treatment, NSMTT was 0.6%, after 60 min treatment, NSMTT was -1.2%. The results were corrected accordingly. Moreover, the test item showed no colouring potential after mixture with aqua dest. but colouring was detected after mixture with isopropanol. Since there was no relevant absorption in the range of 570 ± 30 nm, NSCliving(non-specific colour of additional viable tissues) was not determined.
The corrosivity potential was predicted from the relative mean tissue viabilities obtained after 3 min and 60 min treatment compared to the negative control tissues concurrently treated with Aqua dest (= 100%). According to the Prediction Model: a mean relative tissue viability of ≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure conclude to a non-corrosive effect of the test item. Due to a borderline result (17.4%) the 60 min treatment period was repeated. The mean relative tissues viability (% of negative control) was 87.2 % (NSMTT-redcuced) after 3 min treatment and was 17.4 % and 20.9% after 60 min treatment.
According to the Prediction Model, the test item showed no corrosive effects.
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