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EC number: 307-988-5 | CAS number: 97808-67-8
- 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
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8). The studies are as mentioned below:
The Local Lymph Node Assay (LLNA) was conducted by peer reviewed journal on Female CBA/Ca mice to assess the skin sensitization potential of read across chemical. The LLNA was conducted on groups of CBA/Ca mice (8-12 weeks of age) by mean of topical application of chemical on the dorsum of both ears at a dose of 25µl of one of three concentrations (10%, 25% and 50%)of the test chemical. 5 days after the first topical application, all mice were injected iv with 250µl phosphate buffered saline (PBS) containing 20µCi of [3H]methyl thymidine (3HTdR) .The mice were killed 5 hr later and the draining auricular lymph nodes excised and pooled for each experimental group. A single cell suspension of lymph node cells (LNC) was prepared by gentle disaggregation through 200 mesh stainless steel gauze. Pooled LNC were pelleted by centrifugation at 190g for 10 min, washed twice with 10 ml PBS and resuspended in 3 ml 5% trichloroacetic acid (TCA). After incubation overnight at 4°C, the precipitate was recovered by centrifugation, resuspended in I ml 5% TCA and transferred to 10 ml scintillation fluid. Incorporation of3HTdR was measured by p-scintillation counting.The proliferative response of LNC was expressed as mean radioactive disintegrations per minute per lymph node (dpm/node for each experimental group and as the ratio of3HTdR incorporation into LNC of test nodes relative to control nodes [test: control (T:C) ratio]. A chemical was regarded as a sensitizer in the LLNA if at least one concentration resulted in a T:C ratio of 3 or greater and the data were not incompatible with a biological dose response. The test: control (T:C) ratios were 1.0, 1.0 and 0.9 at concentration of 10% ,25% and 50% respectively. Since the resulted test: control (T:C) ratio was less than 3 at each concentration, the test chemical was considered to be not sensitizing in Local Lymph Node Assay (LLNA).
The above results were further supported by the patch test reported by safety assessment report for read across chemical. A patch test was conducted on humans to assess the skin sensitization potential of test chemical.When the chemical was applied on the skin of human, none of the treated subject induced any signs of contact allergy. Hence the test chemical was considered as not sensitizing to the skin of human subjects.
Based on the above summarized studies for target chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) and its structurally similar read across substances,it can be concluded that the testchemical failed to induce skin sanitization effects and unable to cause skin sensitizing effects. Thus, comparing with the criteria of CLP regulation, Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) can be classified as non-skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- LLNA and non-LLNA
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by patch test on humans and Local Lymph Node Assay on mouse. - GLP compliance:
- not specified
- Type of study:
- other: 1. mouse local lymphnode assay (LLNA) 2. Patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: 1.Mouse 2. Human
- Strain:
- other: 1.CBA/Ca 2.Not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- 1.Age at study initiation: 8-12 week.
2.No data available - Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- No data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- No data available
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Vehicle:
- dimethylformamide
- Concentration:
- 25 µl of 10% ,25% and 50%,
- No. of animals per dose:
- 4
- Details on study design:
- Treatment was performed daily for 3 consecutive days with 25 µl of one of three concentrations of the test chemical on the dorsum of each ear. 5 days after the first topical application, all mice were injected iv with 250µl phosphate buffered saline (PBS) containing 20µCi of [3H]methyl thymidine (3HTdR) .The mice were killed 5 hr later and the draining auricular lymph nodes excised and pooled for each experimental group. A single cell suspension of lymph node cells (LNC) was prepared by gentle disaggregation through 200 mesh stainless steel gauze. Pooled LNC were pelleted by centrifugation at 190g for 10 min, washed twice with 10 ml PBS and resuspended in 3 ml 5% trichloroacetic acid (TCA). After incubation overnight at 4°C, the precipitate was recovered by centrifugation, resuspended in 1 ml 5% TCA and transferred to 10 ml scintillation fluid. Incorporation of 3HTdR was measured by p-scintillation counting.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- No data available
- No. with + reactions:
- 0
- Clinical observations:
- No skin sensitization was observed in treated humans.
- Remarks on result:
- no indication of skin sensitisation
- Parameter:
- other: test: control (T:C) ratio
- Value:
- 1
- Test group / Remarks:
- 4
- Remarks on result:
- other: at concentration of 10% and 25%
- Parameter:
- other: test: control (T:C) ratio
- Value:
- 0.9
- Test group / Remarks:
- 4
- Remarks on result:
- other: at concentration of 50%
- Cellular proliferation data / Observations:
- 1. The test: control (T:C) ratio was less than 3 at each concentration.
2.No skin sensitization was observed in treated humans. - Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) was considered to be not sensitizing to the skin.
- Executive summary:
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8). The studies are as mentioned below:
The Local Lymph Node Assay (LLNA) was conducted by peer reviewed journal on Female CBA/Ca mice to assess the skin sensitization potential of read across chemical. The LLNA was conducted on groups of CBA/Ca mice (8-12 weeks of age) by mean of topical application of chemical on the dorsum of both ears at a dose of 25µl of one of three concentrations (10%, 25% and 50%)of the test chemical. 5 days after the first topical application, all mice were injected iv with 250µl phosphate buffered saline (PBS) containing 20µCi of [3H]methyl thymidine (3HTdR) .The mice were killed 5 hr later and the draining auricular lymph nodes excised and pooled for each experimental group. A single cell suspension of lymph node cells (LNC) was prepared by gentle disaggregation through 200 mesh stainless steel gauze. Pooled LNC were pelleted by centrifugation at 190g for 10 min, washed twice with 10 ml PBS and resuspended in 3 ml 5% trichloroacetic acid (TCA). After incubation overnight at 4°C, the precipitate was recovered by centrifugation, resuspended in I ml 5% TCA and transferred to 10 ml scintillation fluid. Incorporation of3HTdR was measured by p-scintillation counting.The proliferative response of LNC was expressed as mean radioactive disintegrations per minute per lymph node (dpm/node for each experimental group and as the ratio of3HTdR incorporation into LNC of test nodes relative to control nodes [test: control (T:C) ratio]. A chemical was regarded as a sensitizer in the LLNA if at least one concentration resulted in a T:C ratio of 3 or greater and the data were not incompatible with a biological dose response. The test: control (T:C) ratios were 1.0, 1.0 and 0.9 at concentration of 10% ,25% and 50% respectively. Since the resulted test: control (T:C) ratio was less than 3 at each concentration, the test chemical was considered to be not sensitizing in Local Lymph Node Assay (LLNA).
The above results were further supported by the patch test reported by safety assessment report for read across chemical. A patch test was conducted on humans to assess the skin sensitization potential of test chemical.When the chemical was applied on the skin of human, none of the treated subject induced any signs of contact allergy. Hence the test chemical was considered as not sensitizing to the skin of human subjects.
Based on the above summarized studies for target chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) and its structurally similar read across substances,it can be concluded that the test chemical failed to induce skin sanitization effects and unable to cause skin sensitizing effects. Thus, comparing with the criteria of CLP regulation, Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) can be classified as non-skin sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8). The studies are as mentioned below:
The Local Lymph Node Assay (LLNA) was conducted by peer reviewed journal on Female CBA/Ca mice to assess the skin sensitization potential of read across chemical. The LLNA was conducted on groups of CBA/Ca mice (8-12 weeks of age) by mean of topical application of chemical on the dorsum of both ears at a dose of 25µl of one of three concentrations (10%, 25% and 50%)of the test chemical. 5 days after the first topical application, all mice were injected iv with 250µl phosphate buffered saline (PBS) containing 20µCi of [3H]methyl thymidine (3HTdR) .The mice were killed 5 hr later and the draining auricular lymph nodes excised and pooled for each experimental group. A single cell suspension of lymph node cells (LNC) was prepared by gentle disaggregation through 200 mesh stainless steel gauze. Pooled LNC were pelleted by centrifugation at 190g for 10 min, washed twice with 10 ml PBS and resuspended in 3 ml 5% trichloroacetic acid (TCA). After incubation overnight at 4°C, the precipitate was recovered by centrifugation, resuspended in I ml 5% TCA and transferred to 10 ml scintillation fluid. Incorporation of3HTdR was measured by p-scintillation counting.The proliferative response of LNC was expressed as mean radioactive disintegrations per minute per lymph node (dpm/node for each experimental group and as the ratio of3HTdR incorporation into LNC of test nodes relative to control nodes [test: control (T:C) ratio]. A chemical was regarded as a sensitizer in the LLNA if at least one concentration resulted in a T:C ratio of 3 or greater and the data were not incompatible with a biological dose response. The test: control (T:C) ratios were 1.0, 1.0 and 0.9 at concentration of 10% ,25% and 50% respectively. Since the resulted test: control (T:C) ratio was less than 3 at each concentration, the test chemical was considered to be not sensitizing in Local Lymph Node Assay (LLNA).
The above results were further supported by the patch test reported by safety assessment report for read across chemical. A patch test was conducted on humans to assess the skin sensitization potential of test chemical.When the chemical was applied on the skin of human, none of the treated subject induced any signs of contact allergy. Hence the test chemical was considered as not sensitizing to the skin of human subjects.
Based on the above summarized studies for target chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) and its structurally similar read across substances,it can be concluded that the testchemical failed to induce skin sanitization effects and unable to cause skin sensitizing effects. Thus, comparing with the criteria of CLP regulation, Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) can be classified as non-skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) and similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
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