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EC number: 234-217-9 | CAS number: 10599-90-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, according to GPL..
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Chloramide
- EC Number:
- 234-217-9
- EC Name:
- Chloramide
- Cas Number:
- 10599-90-3
- Molecular formula:
- ClH2N
- IUPAC Name:
- chloranamine
- Test material form:
- other: solution
- Details on test material:
- - solution of Monochloramine at 1 %
- Due to the instability of the Monochloramine, the solution is prepared extemporaneously.
Constituent 1
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 50 µl applied to each tissue.
- Duration of treatment / exposure:
- - 3 min
or
- 60 min - Number of animals:
- Not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Tissue viability (%)
- Value:
- 17
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: Tissue viability (%)
- Value:
- 4.7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 hour. (migrated information)
In vivo
- Irritant / corrosive response data:
- - Reduction of MTT by test substance:
After the one hour incubation, the MTT solution control (orange/red) remained unchanged. The initial colour of the test substance, Monochloramine/MTT mixture was red and then purple/red with purple colour on the bottom of the well after the one hour incubation indicating the test substance had reduced the MTT. As the test substance had reduced the MTT, freeze killed tissues (which have no metabolic activity but absorb and bind the test substance like viable tissues) were included in the assay together with the live tissues as a control.
- Check for colouring potential of test substance:
The test substance, Monochloramine/water solution and water control were colourless after the 15 minute shaking period. Therefore, the test substance had not shown any potential for colouring water.
Any other information on results incl. tables
The results after the treatment with the test substance are summarised in the following table:
Sample |
Tissue viability as % of mean negative control value |
Prediction |
|||
3 minute contact |
1 hour contact |
||||
Replicate |
Mean±SD |
Replicate |
Mean±SD |
||
Negative Control (purified water) |
97.1 |
100.0 ± 4.038 CV = 0.0 |
93.9 |
100.0 ± 8.589 CV = 0.086 |
Not applicable |
102.9 |
106.1 |
||||
Monochloramine |
8.3 |
17.0 ± 12.223 CV Not applicable |
5.2 |
4.7 ± 0.782 CV Not applicable |
Corrosive, sub-category 1 |
25.6 |
4.1 |
||||
Positive control (8.0 N KOH) |
11.7 |
12.3 ± 0.942 CV Not applicable |
2.1 |
1.9 ± 0.269 CV Not applicable |
Corrosive, sub-category 1 |
13.0 |
1.7 |
SD = Standard Deviation CV = Coefficient of Variation
The negative control:
The mean optical density of each duplicate negative control value for the three minute and one hour contact were 1.686 and 1.612, respectively. Both values were between the acceptance range of ≥0.8 to ≤2.8.
The positive control:
The mean relative tissue viability of the positive control, 8.0 N potassium hydroxide, for the one hour application was 1.9%. This value was below the maximum acceptable value of 15%.
Inter-tissue viability difference:
The coefficient of variation (CV) was not applicable for the test substance, Monochloramine, and positive control three minute and one hour applications, as the mean percentage viability was below the 20% - 100 % viability range. All other values did not exceed the CV value of 0.3.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, test substance is considered to be corrosive to skin (sub-category 1).
- Executive summary:
The objective of this test was to assess the skin corrosivity,in vitro, of the test substance, Monochloramine (solution of 1 % ).
The test substance was applied for three minutes and one hour to the EpiDerm™ three-dimensional human skin model. The model consisted of normal, human-derived epidermal keratinocytes, which had been cultured on 0.6 cm2 inserts to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity assessed by the reduction of MTT (3‑(4,5‑dimethylthiazol‑2‑yl)‑2, 5‑diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The formazan produced was quantified by spectrophotometric measurement. The prediction model uses the percentage viability values (compared to negative control viability) at three minute and one hour exposure times to identify corrosive and non-corrosive substances.
The test substance, Monochloramine, elicited a mean tissue viability of 17.0% for three minute contact and 4.7% for one hour contact and was predicted as corrosive, sub-category 1, in the EpiDerm™ skin corrosivity test.
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