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EC number: 690-526-2 | CAS number: 38632-47-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Crl:NMRI BR (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item Katalysator W AZ 5596-B.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt
- EC Number:
- 690-526-2
- Cas Number:
- 38632-47-2
- Molecular formula:
- C8H14S2N2O8.Na2
- IUPAC Name:
- Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt
- Details on test material:
- content: 31.94% hexamethylenediisocyanate-bisulfiteadduct (not used for calculation)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv
- Concentration:
- Group 1 Vehicle (Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv)
Group 2 2% Isotan LP RJE 69140 (in Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv)
Group 3 10% Isotan LP RJE 69140 (in Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv)
Group 4 50% Isotan LP RJE 69140 (in Pluronic PE 9200 / 0.9% NaCl solution 1 % vIv) - No. of animals per dose:
- 6 animals/test item group and 6 control animals
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- 1. Direct LLNA (NMRI mice, female, 6 animalsl group) Dose (%) Weight index Cell count index (index of mean +/-SD in %) 0 1.00 +/-18.53 1.00 +/-23.24 2 1.16 +/-23.50 1.13 +/-16.65 10 1.32 +/-16.21 1.26 +/-27.83 50 1.10 +/-16.16 1.18 +/-18.50 Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm) Dose (%) day 1 day4 Index day4 (mean +/- SD in %) 0 18.25 +/- 7.06 18.00 +/- 4.74 1.00 2 18.33 +/- 4.84 18.17 +1- 6.98 1.01 10 18.33 +/- 4.25 17.92 +/- 3.73 1.00 50 18.42 +/- 3.63 17.83 +/- 3.24 0.99 Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch) Dose (%) day4 Index day4 (mean +/- SD in %) 0 11.51 +/-5.44 1.00 2 11.17 +/- 8.12 0.97 10 11.45 +/- 4.45 0.99 50 11.36 +/- 6.90 0.99
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: not applicable
Any other information on results incl. tables
Compared to vehicle-treated animals, none of the parameters measured in the substance treated groups, i.e. cell counts and weights of the draining lymph nodes, ear weights and ear swelling, reached or exceeded the "positive levels" defined for this assay.
These results show that there is no indication for a skin sensitizing effect after administration of a concentration of up to and including 50% Isotan LP RJE 69140 in this test system.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
A modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Hsd Win:NMRI (6 animals/ test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of
the test item Isotan LP RJE 69140.
The study was conducted according to OECD Guidelines No. 429 and No. 406, EC Guideline 2004/73IEC (29th Adaptation of Guideline 67/5481EEC, B.42)lHealth Effects Test Guideline and OPPTS 870.2600 (EPA) with the following test item concentrations:
o (vehicle control), 2%, 10% and 50%.
The test item was formulated in Pluronic PE 9200 I 0.9% NaCl solution 1 % v/v to yield an emulsion in the low concentration and a solution in the mid and the high concentration.
Compared to vehicle-treated animals, none of the parameters measured in the substance treated groups, i.e. cell counts and weights of the draining lymph nodes, ear weights and ear swelling, reached or exceeded the "positive levels" defined for this assay.
These results show that there is no indication for a skin sensitizing effect after administration of a concentration of up to and including 50% Isotan LP RJE 69140 in this test system.
In conclusion, these results show that the test item Isotan LP RJE 69140 has no sensitizing potential in rnice after dermal application of up to and including a 50% concentration. No indication for a non-specific (irritant) activation was detected, too. Therefore, the
concentration of 50% tumed out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.
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