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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
Skin irritation
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation 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 acute dermal irritation study was conducted for the read across chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was obtained to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days observation period after patch removal. Hence, it was concluded that the test substance was non-Irritating to the skin of rats under the experimental conditions tested.
The above result was further supported by a Patch test reported by safety assessment report for another similar read across substance which was conducted on humans in accordance with IMDG code (2002) to assess the irritation potential of test chemical. About 50 mg was applied under occlusive conditions to the inner arm of 5 male volunteers for 6 hours. The test site was observed for erythema and edema till 14 days post dosing. Since the chemical did not produce any skin lesions, the test chemical was considered as not irritating to the skin.
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 and functionally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified.
Eye irritation
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the eye irritation 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:
An ocular irritation test was conducted on rabbits by peer reviewed journal to determine the eye irritation potential of read across chemical. The chemical did not induce any ocular lesions during the study. Hence the test chemical was considered as not irritating.
The above results were further supported by another eye irritation study reported by safety assessment report on rabbits for another read across substance.When the chemical was instilled into the eyes of each rabbit, no signs of eye irritation were observed. Hence the test chemical was considered as not irritating to the rabbits’ eyes.
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 and functionally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 irritation studies as- WoE-2 and WoE-3.
Skin irritation study of test chemical was conducted on rats and humans to assess its skin irritating effects. - GLP compliance:
- not specified
- Species:
- other: 1.Rat 2.Human
- Strain:
- other: 1.Sprague-Dawley 2.Not specified
- Details on test animals or test system and environmental conditions:
- 1. TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 8 – 12 weeks were used.
- Weight at study initiation: The weight range of approximately 221.7 to 255.3 grams at initiation of dosing.
Body weights at the start :
Male
Mean : 249.20 g (= 100 %)
Minimum : 243.9 g (- 2.13 %)
Maximum : 255.3 g (+ 2.45 %)
Total No. of animals : 5
Female
Mean : 225.60 g (= 100 %)
Minimum : 221.7 g (- 1.73 %)
Maximum : 230.5 g (+ 2.17 %)
Total No. of animals : 5
- Identification: Each rat was individually identified by the cage number.
- Fasting period before study: No data available
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.5 degree centigrade.
- Humidity (%): 53.2% to 58.8%
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: 20-07-2017 to 04-08-2017
2.male: age 27-48
2. - Type of coverage:
- other: 1.semiocclusive 2.occlusive
- Preparation of test site:
- other: 1. clipped 2. Not specified
- Vehicle:
- other: 1. water 2. unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 1.2000 mg/kg bw
2.ca. 50 mg/patch (direct) on an inner arm - Duration of treatment / exposure:
- 1.24 hours
2.6 hours - Observation period:
- 1. 14 days
2.14 days - Number of animals:
- 1.10 (5/sex).
2.5(male) - Details on study design:
- 1.TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.
SCORING SYSTEM: Draize Method.
OTHER OBSERVATIONS
Type and Frequency of Tests, Analyses and Measurements
Viability:Twice daily.
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.
2. Not specified - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1.Overall result:
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
2. No skin irritation was observed in treated group, - Other effects:
- 1.Other effects:
Clinical Signs of Toxicity and Mortality
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Body Weight
Sex : Male
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 8.58% and 18.09% respectively.
Sex : Female
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.54% and 9.72% respectively.
Gross Pathological Findings
Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
2.No skin irritation was observed in treated group, - Interpretation of results:
- other: Not irritating
- Conclusions:
- The test chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) was considered as not irritating.
- Executive summary:
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation 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 acute dermal irritation study was conducted for the read across chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was obtained to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days observation period after patch removal. Hence, it was concluded that the test substance was non-Irritating to the skin of rats under the experimental conditions tested.
The above result was further supported by a Patch test reported by safety assessment report for another similar read across substance which was conducted on humans in accordance with IMDG code (2002) to assess the irritation potential of test chemical. About 50 mg was applied under occlusive conditions to the inner arm of 5 male volunteers for 6 hours. The test site was observed for erythema and edema till 14 days post dosing. Since the chemical did not produce any skin lesions, the test chemical was considered as not irritating to the skin.
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 and functionally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified.
Reference
1.
Table No. I
Summary of Clinical Signs of Toxicity and Mortality
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
1 - 5 |
Day 0 - Day 14 |
0/5 |
Sex : Female
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
6 - 10 |
Day 0 - Day 14 |
0/5 |
Table No. II
Summary of Evaluation of Dermal Reaction
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
1 - 5 |
Day 0 - Day 14 |
0/5 |
Sex : Female
Group No. |
Dose mg/kg |
Dermal Reaction |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No dermal reaction observed |
5 |
6 - 10 |
Day 0 - Day 14 |
0/5 |
Table No.III
Mean Body Weight and Percent Body Weight Gain (g)
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
2000 |
Mean |
249.20 |
270.66 |
8.58 |
294.34 |
8.77 |
18.09 |
± SD |
4.57 |
9.96 |
2.02 |
9.37 |
1.21 |
1.70 |
Sex : Female
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
2000 |
Mean |
225.60 |
238.12 |
5.54 |
247.52 |
3.98 |
9.72 |
± SD |
3.57 |
5.80 |
1.18 |
5.22 |
2.68 |
1.96 |
Table No.IV
Summary of Gross Pathological Findings
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
1 - 5 |
TS |
No abnormality detected |
Sex : Female
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
6 - 10 |
TS |
No abnormality detected |
TS = Terminal Sacrifice
2. Not specified
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 and functionally 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 eye irritation studies as- WoE-2 and WoE-3.
An eye irritation study of test chemical was conducted on rabbits to assess its eye irritating effects. - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 1.not specified
2.10% solution - Duration of treatment / exposure:
- not specified
- Observation period (in vivo):
- not specified
- Duration of post- treatment incubation (in vitro):
- not specified
- Number of animals or in vitro replicates:
- not specified
- Details on study design:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No ocular lesions were observed in traeted rabbits.
- Interpretation of results:
- other: not Irritating
- Conclusions:
- The chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) was considered as not irritating.
- Executive summary:
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the eye irritation 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:
An ocular irritation test was conducted on rabbits by peer reviewed journal to determine the eye irritation potential of read across chemical. The chemical did not induce any ocular lesions during the study. Hence the test chemical was considered as not irritating.
The above results were further supported by another eye irritation study reported by safety assessment report on rabbits for another read across substance.When the chemical was instilled into the eyes of each rabbit, no signs of eye irritation were observed. Hence the test chemical was considered as not irritating to the rabbits’ eyes.
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 and functionally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation 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 acute dermal irritation study was conducted for the read across chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was obtained to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days observation period after patch removal. Hence, it was concluded that the test substance was non-Irritating to the skin of rats under the experimental conditions tested.
The above result was further supported by a Patch test reported by safety assessment report for another similar read across substance which was conducted on humans in accordance with IMDG code (2002) to assess the irritation potential of test chemical. About 50 mg was applied under occlusive conditions to the inner arm of 5 male volunteers for 6 hours. The test site was observed for erythema and edema till 14 days post dosing. Since the chemical did not produce any skin lesions, the test chemical was considered as not irritating to the skin.
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 and functionally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified.
Eye irritation
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the eye irritation 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:
An ocular irritation test was conducted on rabbits by peer reviewed journal to determine the eye irritation potential of read across chemical. The chemical did not induce any ocular lesions during the study. Hence the test chemical was considered as not irritating.
The above results were further supported by another eye irritation study reported by safety assessment report on rabbits for another read across substance.When the chemical was instilled into the eyes of each rabbit, no signs of eye irritation were observed. Hence the test chemical was considered as not irritating to the rabbits’ eyes.
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 and functionally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified.
Justification for classification or non-classification
The skin and eye irritation potential of test chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical is unlikely to cause skin and eye irritation. Hence Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS No: 97808-67-8) can be classified under the category “Not Classified” for skin and eye as per CLP.
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