Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-847-9 | CAS number: 127-52-6
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although information on test material is limited, the study was performed according to valid methods; therefore it is considered adequate, relevant and reliable.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC method No. 1907/2008
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- CAS 127-52-6 trihydrate
- IUPAC Name:
- CAS 127-52-6 trihydrate
- Test material form:
- solid: crystalline
- Details on test material:
- Substance arrived 4 August 2010, otherwise no data.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- pig
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Duration of exposure:
- Skin preparation 1 (1h), preparation 2 (2h), preparation 3 (4h), preparation 4 (6h), preparation 5 (8h), preparation 6 (24h) at laboratory temperature (cell system maintained at 34°C).
- Doses:
- Application to the skin: 40 µL of the test sample was applied using an automatic pipette on the skin preparations. In each of the two independent runs 6 skin preparations were used.
Quantification of the applied dose: the applied dose was weighed up 3x, the average value was used for calculations. - Details on in vitro test system (if applicable):
- Full-thickness porcine skin supplied by B+B Agro, 289 01 Číněves, without scalding, was used in the test. A sheet of skin from both sides of the backbone (cca 40 x 70 cm) was treated in the laboratory within 6 hours after slaughter. The subcutaneous fat was removed using electrical knife and blunt butcher knife.The skin was shaved by electrical shaver, washed with lukewarm water and let to dry. With a punching pin the skin was divided into disc-shaped pieces, (diameter 5cm), which were stored in vacuum bags with designated date of preparation and frozen (-18°). Prior to testing (2-3 hours) the skin preparations were defrozen on air at laboratory temperature.
Metabolic status: metabolically non-active.
Apparatus for skin absorption:
The used static Franz diffusion cells consisted of a donor chamber (in the form of a glass cap with an opening in the center) and receptor chamber double bottom glass diameter cca 2 cm,volume cca 5 mL).The receptor fluid was applied in the receptor chambers, the cells were connected by a system of tubes with a water bath and the temperature was maintained at 34°C. The system was placed on a magnetic stirrer (Variomag Poly, Labortechnik AG, Germany) set for 310 rPm.
Procedure of fractionation: at the end of exposure the skin surface was wiped using a metal spatula (fraction 1), the skin preparation was then cut into small pieces (fraction 2) and the receptor fluid was collected (fraction 3) .
Extraction: extraction vehicle 2-propanol (SIGMA-ALDRICH)
Fraction 1 from the spatula was washed with 4 mL of extraction vehicle. Fraction 2 (skin) was extraced in the extraction vehicle for 24 h at laboratory temperature, homogenized in an ultrasonic bath for 15 min and filtered using Spartan 3O/0,2 RC filters( Schleicher+Schuell).
Method for determination of the tested compound:
Fraction 1 and fraction 3 were analysed immediately after the end of exposure, fraction 2 was analyzed after the 24 hour extraction.
Determination of chloramine-B and its primary degradation product benzenesulfonamide was carried out by means of HPLC-UV method. The
method was used for determination of chloramine-B and benzensulfonamide in the 2-propanol extracts of the skin wipes, whole skin and in the receptor fluid. The resulting concentrations of tested compounds in the analyzed fractions were determined using a calibration curve.
Equipment, column, mobile phase:
HPLC chromatograph ECOM, two pumps LCP 4020, UV-VIS detector LCD
2083, mobile phase mixer Knauer, autosampler HT300L.
The parameters of HPLC analysis are listed below:
- Column: Chromolith performance R P-18E, 100-4.6, Merck
- Guard column: Chromolith RP-18E,10-4.6, Merck
- Mobile phase: 20% methanol in phosphate buffer (pH 3)
- Flow rate: 1 mL/min
- Detection wavelength: 220 nm
- Injection: 20 µl
Results and discussion
- Absorption in different matrices:
- Chloramine B was not found in any analyzed fraction in either experiment. Overall recovery of the degradation product of chloramine B (benzenesulfonamide) in both experiments is presented in table 1.
- Total recovery:
- In the receptor fluid, skin preparation and the on skin surface, only Benzenesulfonamide, the primary degradation product of Chloramine B, has been detected. The tested applied substance, Chloramine B, has not been found in any of the analysed fractions. The penetration of benzenesulfonamide is very low up to 6 hours after application (max.1.18%) and low after 24 hours after application (max.7 .98%).
Percutaneous absorptionopen allclose all
- Dose:
- 40 µL
- Parameter:
- percentage
- Absorption:
- 0 %
- Remarks on result:
- other: 1, 2, 4, 6, 8, 24 h
- Remarks:
- Chloramine B trihydrate
- Dose:
- 40 µL
- Parameter:
- percentage
- Absorption:
- >= 5.1 - <= 7.98 %
- Remarks on result:
- other: 24h
- Remarks:
- Benzenesulfonamide
Any other information on results incl. tables
Table 1. Recovery of benzenesulfonamide in the experiments
Duration of exposure |
Recovery (%) |
|||||
Experiment 1 |
Experiment 2 |
|||||
fraction 1 |
fraction 2 |
fraction 3 |
fraction 1 |
fraction 2 |
fraction 3 |
|
1h |
16.84 |
61.43 |
0.08 |
14.61 |
75.60 |
0.00 |
2h |
11.40 |
65.53 |
0.39 |
11.68 |
74.36 |
0.09 |
4h |
10.18 |
93.29 |
0.83 |
8.95 |
83.36 |
0.18 |
6h |
10.13 |
75.45 |
1.18 |
8.84 |
86.06 |
0.36 |
8h |
6.45 |
69.83 |
3.36 |
5.87 |
85.58 |
2.18 |
24h |
6.29 |
60.02 |
5.10 |
4.51 |
80.58 |
7.98 |
Applicant's summary and conclusion
- Conclusions:
- After application on skin, Chloramine B was not detected in any of the analysed fractions and receptor fluid, it is not absorbed in the skin and does not penetrate. Only the presence of its degradation product, benzenesulfonamide, was detected in the skin fractions and receptor fluid. After short-term exposure its penetration is negligible, after 24 h exposure its penetration is low.
- Executive summary:
Chloramine B was tested in vitro on full-thickness porcine skin according to OECD TG 428 method. Disc-shaped pieces, (diameter 5cm) were defrozen prior to testing (2-3 hours). Metabolic status was metabolically non-active. 40 µL was applied for different durations (1h, 2h, 4h, 6h, 8h and 24h). At the end of exposure the skin surface was wiped using a metal spatula (fraction 1), the skin preparation was then cut into small pieces (fraction 2) and the receptor fluid was collected (fraction 3) .
After application on skin, Chloramine B was not detected in any of the analysed fractions and receptor fluid, it is not absorbed in the skin and does not penetrate. Only the presence of its degradation product, benzenesulfonamide, was detected in the skin fractions and receptor fluid. After short-term exposure its penetration is negligible, after 24 h exposure its penetration is low.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.