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EC number: 215-578-1 | CAS number: 1333-07-9
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 30 May 2006 - 01 September 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed accrding to guideline and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tosylchloramide sodium
- EC Number:
- 204-854-7
- EC Name:
- Tosylchloramide sodium
- Cas Number:
- 127-65-1
- IUPAC Name:
- sodium chloro[(4-methylphenyl)sulfonyl]azanide
- Reference substance name:
- Chloramine-T
- IUPAC Name:
- Chloramine-T
- Details on test material:
- Non-radiolabeled
Test material name: Halamid
Other name: Chloramine T trihydrate
Batch number: 50210
Appearance: white powder
Chemical purity: 99.7%
Supplier: Sigma-Aldrich
Storage conditions: ambient temperature
radiolabeled
Test material name: [14C]-Halamid
Other name: [ring-U-14C]-Chloramine T (trihydrate)
Batch number: CFQ14688
Specific activity: 23 mCi.mmol
Radiochemical purity: 97.2% (HPLC, on 29 March 2006)
Supplier: GE Healthcare
Storage conditions: ≤ 18 ºC
Constituent 1
Constituent 2
- Radiolabelling:
- yes
Test animals
- Species:
- human
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Duration of exposure:
- 8 hours
- Doses:
- 300 or 50 µg/cm2, 3% or 0.5% solutions in water.
- No. of animals per group:
- 6 skin membranes were used per dose and 2 skin membranes were prepared from each donor for each test group (A and B)
- Control animals:
- no
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Human, 3 donors, freshly excised skin following abdominal surgery.
- Preparative technique: dermatomed to approx. 400μm.
Recorded: - Thickness of skin (in mm): - Membrane integrity
PRINCIPLES OF ASSAY
- Diffusion cell: The skin membranes were placed in 9 mm flow-through automated diffusion cells
- Solubility of test substance in receptor fluid sufficient: exceeds the required solubility by a factor 6.
- Flow-through system: The receptor fluid was pumped at a speed of cu 1.6 mL/h
- Test temperature: The mean skin surface tempenture was 32 ± 1 ºC
- Reference substance(s): none
Results and discussion
- Absorption in different matrices:
- see: remarks on results including tables and figures
- Total recovery:
- - Total recovery: The mean recovery was 95.4% (high dose) and 94.0% (low dose)
- Recovery of applied dose acceptable: yes
- Results adjusted for incomplete recovery of the applied dose: no
- Limit of detection (LOD):
- Quantification of values below LOD or LOQ:
Any other information on results incl. tables
Stability:
In the receptor fluid, a rapid degradation of Chloramine-T trihydrate towards p-TSA was observed. A few minutes after preparing a 30mg/l solution 71.7% Chloramine-T trihydrate was left. The concentration further decreased from 48.9%, 29.2% to 14.5% after 7, 24 and 48 hours.
Directly after dosing, the dose solutions were analyzed by radio-HPLC. The relative amount of Chloramine-T trihydrate in the both dose solutions was 94 70 based on W detection. Based on radio-activity, this percentage was lower (ca 72%) due to additional peaks in the beginning of the radio-chromatogram most probable related to a breakdown of the radio-label. Degradation will most likely take place to p-TSA (as is observed in the stability test using receptor fluid). It is not expected that only the radio-activity associated with the unknown peaks will be absorbed through the skin. A rapid a degradation of Chloramine-T trihydrate to p-TSA on the skin surface was confirmed by analyzing the cotton swab extracts. After 8 hours contact time, only ca 23 and ca 2.3 % Chloramine-T trihydrate was left in the coton swab extracts of the high and low dose group, respectively. It is therefore reasonable to assume that the main compound reaching the receptor fluid will be p-TSA. In the skin wash solution, Chloramine-T trihydrate was relatively stable deceted in time at 92% until 48 hours.
* The exact concetration is described in the method section.
**Total absorption is defined as the amount in the receptor fluid, the receptor compartment wash and the skin membrane, excluding the amount in the tape strips.
The in vitro percutaneous penetration of Halamid
Halamid | A | B | ||
concentration measured (g/L) | 30.0* | 5.0* | ||
Dose (µg/cm2) | 300* | 50 * | ||
n | 6 | 6 | ||
penetration into the receptor fluid after 24 h | % of dose | µg/cm2 | % of dose | µg/cm2 |
4.01 | 12.0 | 11.49 | 5.74 | |
maximal flux (µg/cm2/h) | 0.652 | 0.367 | ||
Lag time (h) | 2.7 | 4.0 | ||
Total absorption (%)** | 9.7 | 20.0 |
Applicant's summary and conclusion
- Conclusions:
- The mean total adsorption of a 3% aqueous Chloramine-T trihydrate solution on human skin is 9.7%. The mean total adsorption of a 0.5% aqueous Chloramine-T trihydrate solution on human skin is 20.0%
- Executive summary:
According to OECD 428 and under GLP the percutaneous absorption of [14C]-Chloramine-T trihydrate in a 3% and 0.5% aqueous solution was evaluated on 6 freshly excised human membranes (2 from one donor). The chemical stability of Chloramine-T trihydrate was determined prior to the conduct of the study aiming at a later analysis of receptor fluid and skin wash fractions obtained in the main study. Skin membranes from three different human donors were used. The exposure time was 8 hours, after which the test compound was washed from the skin and the post-exposure time was 16 hours. Samples were taken from receptor fluid samples, skin wash. Receptor compartment wash, donor compartment wash, tape strips, and digested skin. All collected samples were analyzed with liquid scintillation counting (LSC).To determine the extent of (metabolic) degradation of Chloramine-T trihydrate into p-TSA, samples of the skin wash were analyzed by radio- LC. The total absorption is defined as the amount in the receptor fluid, the receptor compartment wash and the skin membrance, excluding the amount in the tape strips.
A rapid degradation of Chloramine-T trihydrate towards p-TSA was observed in the receptor fluid. Based on UV detection, the relative amount of Chloramine-T trihydrate decreased from 71.7 % established a few, minutes after mixing (t=0) to 14.5 % after 48 hours. In the skin wash solution, Chloramine-T trihydrate was relatively stable detected in time at 92% until 48 hours. For the high dose, the mean penetration of test compound-related radioactivity into the receptor fluid after 24 hours was 12.0 μg/cm2 which was 4.01% of the dose applied. The mean maximal flux was 0.652 μg/cm2/h the lag time was 2.7 h. The mean total absorption, was 9.7%. For the low dose, the mean penetration of test compound-related radioactivity into the receptor fluid after 24 hours was 5.74 μg/cm2 which was 11.49 % of the dose applied The mean maximal flux was 0.367 μg/cm2/h and the lag time was 4.0 h. Slight differences between donors were observed. The mean total absorption was 20.0 %. The mean recovery was 95.4% (high dose) and 94.0 % (low dose). The mean total adsorption of a 3% aqueous Chloramine-T trihydrate solution on human skin is 9.7%. The mean total adsorption of a 0.5% aqueous Chloramine T trihydrate solution on human skin is 20.0%
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