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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
Endpoint summary
Administrative data
Description of key information
No study available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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..
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Not applicable
- 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
- 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)
- 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. - 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin and eye corrosion/irritation assessment:
No in vivo experimental data are available for skin and eye corrosion/irritation endpoints. A sequential testing strategy was applied in order to evaluate the skin corrosivity/ irritancy potential of the solution of Monochloramine solution from 0.25 to 1 %. First, the physicochemical properties were taken into consideration to evaluate the skin and eye corrosivity/ irritancy potential of this substance. Due to the extreme pH (pH = 12.5) of the solution of monochloramine from 0.25 to 1 % (2.5 to 10 g/l) and due to the lack of in vivo experimental data, a corrosive classification is expected. To confirm this classification, an alkaline reserve test and an in vitro skin corrosion using a human skin model were performed. The free alkalinity was determined to be 0.0914 (%mass/mass) with a pH of 13.36. Classification based on the pH-alkali reserve indicates that the substance should be classified as Irritant. Nevertheless, in the EpiDermTMskin corrosivity test, the test substance, Monochloramine (1 % solution), elicited a mean tissue viability of 17 % for three minute contact and 4.7 % for one hour contact and was predicted as corrosive, sub-category 1. Therefore, the corrosive classification of Monochloramine (1 % solution) is confirmed and maintained.
The solution of Monochloramine below or equal at 0.0003 % (3 mg/l) was also considered to evaluate its skin and eye corrosivity/ irritancy potential since workers may also be exposed at concentrations below 0.0003 % (3 mg/l). At concentrations below or equal 0.0003 % (3 mg/l), the pH of the solution is around 8. Therefore, the corrosive classification due to the extreme pH should not be applied. In addition, in the United States, Monchloramine is used to provide disinfection residual in drinking-water distribution systems where it is difficult to maintain free chlorine residual or where the formation of disinfection by-products is a problem. Levels up to 4 mg/l are typically added and decrease with length of residence to around 0.6 mg/l. The WHO (1998) has established a drinking-water guideline for monochloramine of 3 mg/l. Australia and New Zealand have also established a guideline of 3 mg/l for monochloramine (National Health and Medical Research Council and Agriculture and Resource Management council of australia and New zealand, 1996). In Canada, the maximum allowable concentration for total chloramines has been established at 3.0 mg/l (Health Canada, 2003). Based on the large uses in different countries of drinking-water containing monochloramine levels up to 3 mg/l, no classification is applied for concentrations below or equal at 0.0003 % (3 mg/l).
Respiratory irritation assessment:
Monochloramine belongs to the chloramine category that contains also dichloramine and trichloramine. Trichloramine, is recognized as a strong irritant and lacrimator. Gagnaire et al. (1994) evaluated the expiratory bradypnoea (indicative of upper airway irritation) in mice during a 60 min oronasal exposure to increasing concentrations of trichloramine. The airborn concentration resulting in a 50 % decrease in the respiratory rate of mice (RD50) was calculated for trichloramine. The RD50 value of trichloramine was 2.5 ppm (12.3 µg/ml) and the maximal response to trichloramine was reached in 10 minutes. In addition, it has been assumed that chloramines are responsible for the irritation experienced by swimming pool workers or by workers in a salad processing plant (Heri et al., 1994 and 1998). The presence of chloramines in swimming pool atmospheres is likely an account of the reaction between the chlorine-containing agents used for disinfecting the water and nitrogenous compounds introduced by humans. From questionnaires completed by the swimming pool instructors and measurements of the concentration of chloramine in the atmosphere, the irritation phenomena seemed to appear at chloramine values of around 0.5 mg/m3. In the green salad processing plant, using water containing chlorine or sodium hypochlorite, chlorine and hypochlorous acid coming into contact with the biological fluids from poultry processing lead to the formation of inorganic chloramines. In the case of vegetable processing industry, the source of the nitrogen compounds necessary for chloramine formation is probably the sap proteins released when cutting the vegetable. Results indicated that chloramine exposure in swimming pools is mainly composed of nitrogen trichloride although for vegetable processing facilities workers seemed mainly exposed to a mixture of mono- and dichloramine. Then, based on human exposures reported in the open scientific literature it can be assess that monochloramine, dichloramine and trichloamine are respiratory irritants.
Justification for selection of skin irritation / corrosion endpoint:
In an EpiDermTM skin corrosivity test, the test substance, Monochloramine (1 % solution), elicited a mean tissue viability of 17 % for three minute contact and 4.7 % for one hour contact and was predicted as corrosive, sub-category 1. Then, the in vitro result confirmed the corrosive classification predicted by the extreme pH (pH = 12.5) of the solution of monochloramine at 1 %.
Justification for selection of eye irritation endpoint:
Based on the EpiDerm TM skin corrosivity test result, the monochloramine (1 % solution) is expected to be also corrosive to eyes.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Effects on respiratory irritation: irritating
Justification for classification or non-classification
Based on the worst case assumption, as there are no in vivo experimental data available, the monochloramine have to be classified as
Skin corrosion/irritation:
DSD C, R35: Causes severe burns; CLP Skin Corr. 1A, H314: Causes severe skin burns and eye damage (monochloramine solution from 2.5 to 10 g/l)
DSD: not classified; CLP: not classified (monochloramine < or = 3 mg/l)
Eye corrosion/irritation:
Implicit in classification as corrosive (monochloramine solution from 2.5 to 10 g/l)
DSD: not classified; CLP: not classified (monochloramine < or = 3 mg/l)
Respiratory irritation:
DSD Xi; R37: Irritating to respiratory system; CLP/GHS STOT SE 3, H335: May cause respiratory irritation
DSD: not classified; CLP: not classified (monochloramine < or = 3 mg/l)
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