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EC number: 241-680-0 | CAS number: 17691-19-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic Toxicity, Teratologic, and Reproduction Studies with Hair Dyes
- Author:
- THEODORE WBRNICK, BEN MARR LANMAN AND JEAN LOUIS FIUUX
- Year:
- 1 975
- Bibliographic source:
- TOXICOLOGY AND APPLIED PHARMACOLOGY 32,450-460 (1975)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Reproductive toxicity study of Sodium m-nitrobenzenesulfonate was performed on Sprague Dawley rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Sodium 3-nitrobenzenesulphonate
- EC Number:
- 204-857-3
- EC Name:
- Sodium 3-nitrobenzenesulphonate
- Cas Number:
- 127-68-4
- Molecular formula:
- C6H5NO5S.Na
- IUPAC Name:
- sodium 3-nitrobenzenesulfonate
- Test material form:
- other: pearls
- Details on test material:
- - Name of test material (as cited in study report): Sodium 3-nitrobenzenesulphonate
- Molecular formula (if other than submission substance): C6H5NO5S.Na
- Molecular weight (if other than submission substance): 226.16
- Substance type: Organic
- Physical state: Solid
- Lot/batch No.: 2542
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Sodium 3-nitrobenzenesulphonate
- Molecular formula (if other than submission substance): C6H5NO5S.Na
- Molecular weight (if other than submission substance): 226.16
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animals and env. conditions
TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: male rats: 240 to 280 g and Females: 180 to 220 g.
- Fasting period before study: No data available
- Housing: No data available
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum): Purina laboratory chow, ad libitum except Food was withheld during period of mating.
- Water (e.g. ad libitum): ad libitum
Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test material mixed with into basal diet
DIET PREPARATION
- Rate of preparation of diet (frequency):twice weekly
- Mixing appropriate amounts with (Type of food ): the basal diet of Purina laboratory chow
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 1950, and 7800 ppm(0, 86 and 351 mg/kg bw )
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage:1:2
- Length of cohabitation: From 4 PM to 8 AM the following day.
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy:The appearance of sperm in a vaginal smears (day 0 of pregnancy).
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: [no / yes (explain)]No data available
- After successful mating each pregnant female was caged (how): Pregnant females then were placed in individual cages
- Any other deviations from standard protocol:No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- In Part I, the females received the basal diet from 8 week prior to mating through the weaning of their litters. The males siring these litters were fed the test diets for 8 week prior to mating and during the mating period. In Part II, males received the basal diet for 8 week prior to and during mating, while the females received the test diets 8 week prior to mating and during gestation and 21 days of lactation.
- Frequency of treatment:
- daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0, 1950, and 7800 ppm(0, 86 and 351mg/kg bw )
- No. of animals per sex per dose:
- Total:180
Part I
0ppm:10 male and 20 female
1950 ppm :10 male and 20 female
7800ppm:10 male and 20 female
Part II
0ppm: 10 male and 20 female
1950 ppm : 10 male and 20 female
7800ppm: 10 male and 20 female - Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: daily
BODY WEIGHT: Yes
Time schedule for examinations: daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations: - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- The litters’ were examined for numbers of live and stillborn pups and gross abnormalities. The pups were weighed at birth, and at 4 and 21 days
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: One female pregnant by each male was killed by chloroform inhalation on day 13 of her pregnancy to obtain information regarding the early stages of gestation.
GROSS NECROPSY
The uterus was examined for the number and distribution of embryos, the presence of empty implantation sites, and the number of embryos undergoing resorption. Each embryo was examined under a dissecting microscope. The remaining dams were allowed to deliver normally. A necropsy was performed on all females that did not deliver a litter to determine whether pregnancy had occurred.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- the litters’ were examined for numbers of live and stillborn pups and gross abnormalities
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Statistics:
- The data were subjected to statistical analysis, using the 95% confidence level. The methods used included chi square test, analysis of variance and t test, and the Fisher exact probability test (Snedecor, 1962).
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- At the dietary concentration fed, there were no effects on body weight gains of either males or females
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- At the dietary concentration fed, there were no effects on food consumption of either males or females
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- There were no dose-related significant differences in any of the parameters examined which included male and female fertility, length of gestation, numbers of females with resorption sites, live pups per litter, pup body weights, and pup survival. The female fertility index in the high dosage group in Part I and the average pup weight in the high dosage group in Part II were lower than the control values, but the differences were not statistically significant at the 95% confidence level.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 351 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- reproductive performance
- Remarks on result:
- other: No effects on reproductive performance was observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No abnormal pups were seen upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 351 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: overall developmental effects
- Remarks on result:
- other: No abnormal pups were observed upon gross examination at weaning after 21 days.
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In reproductive toxicity study, the NOAEL was considered to be 7800ppm (351mg/kg)as no dose related effects on reproductive parameters were observed. When male and female Sprague Dawley rats were treated with Sodium m-nitrobenzenesulfonate (127-68-4) orally
- Executive summary:
The reproductive toxicity study ofSodium m-nitrobenzenesulfonate (127-68-4) was performed on male and femaleSprague Dawley rats. The 180 animals divide into six groups; each group consists of 10 males and 20 females.The body weights of the male rats ranged from 240 to 280 g while those of the females ranged from 180 to 220 g.All the animals provided with water and foodbasal diet of Purina laboratory chowad libitum exceptFood was withheld during period of mating. The test material mixed with feed in dose concentration 0, 1950, and 7800 ppm (0, 86 and 351mg/kg bw ). The study divide into two parts, In Part I, and the females received the basal diet from 8 weeks prior to mating through the weaning of their litters. The males siring these litters were fed the test diets for 8 weeks prior to mating and during the mating period. In Part II, males received the basal diet for 8 weeks prior to and during mating, while the females received the test diets 8 week prior to mating and during gestation and 21 days of lactation. One male was placed in a cage with two females from 4 PM to 8 AM the following day. This procedure was continued until copulation was confirmed by the appearance of sperm in a vaginal smear (day 0 of pregnancy). Males were rotated within their dietary groups at I0-day intervals until conception was confirmed or until each female had been mated with a maximum of two males. If one of the two females caged with the male became pregnant, the male was considered fertile. A female was considered infertile if she failed to become pregnant after mating with two different males for 10 days each. Pregnant females then were placed in individual cages. One female pregnant by each male was killed by chloroform inhalation on day 13 of her pregnancy to obtain information regarding the early stages of gestation. The uterus was examined for the number and distribution of embryos, the presence of empty implantation sites, and the number of embryos undergoing resorption. Each embryo was examined under a dissecting microscope. The remaining dams were allowed to deliver normally. A necropsy was performed on all females that did not deliver a litter to determine whether pregnancy had occurred. The duration of gestation was noted and the litters’ were examined for numbers of live and stillborn pups and gross abnormalities. The pups were weighed at birth, and at 4 and 21 days. At 21 days all surviving pups were killed by chloroform inhalation and examined grossly for abnormalities.
At the dietary concentration fed, there were no effects on food consumption and body weight gains of either males or females.There were no dose-related significant differences in any of the parameters examined which included male and female fertility, length of gestation, numbers of females with resorption sites, live pups per litter, pup body weights, and pup survival. The female fertility index in the high dosage group in Part I and the average pup weight in the high dosage group in Part II were lower than the control values, but the differences were not statistically significant at the 95% confidence level.No abnormal pups were seen upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days.Hence, the NOAEL was considered to be 7800ppm (351mg/kg) as no dose related effects on reproductive parameters were observed. When male and femaleSprague Dawley rats were treated withSodium m-nitrobenzenesulfonate (127-68-4) orally.
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