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Diss Factsheets

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
Reference
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.

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”.