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EC number: 247-895-6 | CAS number: 26672-22-0
- 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:
- one-generation reproductive 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 is from J-check
Data source
Referenceopen allclose all
- Reference Type:
- other: Authorized database
- Title:
- "Preliminary Reproduction Toxicity Screening Test of 2-Amino- 5-methylbenzenesulfonic acid by Oral Administration in Rats".
- Author:
- J-check Ministry of Health & Welfare, Japan
- Year:
- 1 999
- Bibliographic source:
- Toxicity Testing Reports of Environmental Chemicals, vol.7 p163-171,
- Reference Type:
- secondary source
- Title:
- Assessment Report for 4-AMINOTOLUENE-3-SULFONIC ACID CAS N°: 88-44-8
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report For SIAM 16 Paris, 27-30 May 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Reproduction Toxicity Screening Test of 2-Amino-5-methylbenzenesulfonic acid by Oral Administration in Rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 4-aminotoluene-3-sulphonic acid
- EC Number:
- 201-831-3
- EC Name:
- 4-aminotoluene-3-sulphonic acid
- Cas Number:
- 88-44-8
- Molecular formula:
- C7H9NO3S
- IUPAC Name:
- 2-amino-5-methylbenzene sulfonic acid
- Details on test material:
- - Name of test material (IUPAC name): 2-Amino-5-Methylbenzenesulfonic Acid
- Common name: p-Toluidine-m-sulfonic acid
- Molecular formula: C7H9NO3S
- Molecular weight: 187.2181 g/mol
- Smiles notation: Cc1ccc(c(c1)S(=O)(=O)O)N
- InChl: 1S/C7H9NO3S/c1-5-2-3-6(8)7(4-5)12(9,10)11/h2-4H,8H2,1H3,(H,9,10,11)
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4-aminotoluene-3-sulphonic acid
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 375-414 g for males, 239-266 g for females
- Diet (e.g. ad libitum): NMF solid feed (radiation sterilized feed) and was taken free during the breeding period, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: sesame oil, 0.5mL/100g body weight
- Details on exposure:
- vehicle: sesame oil, 0.5mL/100g body weight
schedule: once a day by oral gavage
male: before mating 14 days, during mating 14 days, after mating 20 days;
total 48 days
pregnant female: before mating 14 days, during mating (max.) 14 days,
during gestation (about 21 days), after pregnant 3 days; total 41-46 days
not pregnant female: till 25 days after gestation; total 41-43 days
not couplated female: till 20 days after mating period; total 48 days - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: max. 14 days
- Further matings after two unsuccessful attempts: No data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- male 48 days; female 41-48 days.
Premating exposure period
Male :14 days
Female :14 days - Frequency of treatment:
- once a day, every day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 12 per sex per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Duration of test : male: 48 days, female: 41-48 days.
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: every day to all animals.
BODY WEIGHT: Yes
- Time schedule for examinations:
Male body weight: once a week, total 8 times in the 49 days
Female body weight: 1st, 8th, 15th day before mating; 0th, 7th, 14th, 21st day after copulated; 0th, 4th day after pregnant
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): in conformity with those body weights, except during mating for female.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): not checked - Oestrous cyclicity (parental animals):
- Sexual cycle was observation
- Sperm parameters (parental animals):
- Spermatogenesis of the epididymis was observed.
- Litter observations:
- Pups number, sex, weight by sex in each litter, appearance were observed on 0th and 4th day. Dead pups were checked separately
- Postmortem examinations (parental animals):
- Organ weight, gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- Gross pathology were examined.
- Statistics:
- Weight, food consumption, number of corpus luteums, number of implantation traces, number of births, number of stillbirths, sex ratio, average sex, pregnancy period, implantation rate, delivery rate, birth rate, abnormal incidence of abnormal outer table, newborn 4th Multiple comparison test 2-4) was performed on the survival rate, organ weight and relative weight of the subjects.
For the birth rate, mating rate and conception rate, χ ^ 2 tests 5, 6) were used. The incidence of findings of pathological examination was tested using Fisher's direct probability test method 6). In addition, as for the results on newborns during the nursing period, the average per mother was taken as one sample. The level of significance was set at two levels of *: P <0.05 and **: P <0.01. - Reproductive indices:
- copulation index, fertility index, gestation length, number of corpora lutea or implanations, implanation index, gestation index, parturition or maternal behavior.
- Offspring viability indices:
- sex ratio, the live birth index, the viability index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Ocular secretion in 100 mh/kg bw, hair loss in 300 and 1000 mg/kg bw were observed in male rats and hair removal was observed in the 100 mg / kg group through pregnancy
and nursing periods, and in the control group of female rats. No change due to administration of the test substance was observed - Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality were observed in treated rats as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No test substance related change in body weight were observed in treated rats as compared to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- When treated wtih 1000 mg/kg bw, statistically significant increase in food consumption from 1 to 15 days of administration in male rats
no effect on female rats were observed. - 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:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Seminiferous tubular atrophy of the teste, testicular and epididymal atrophy, stromal cell proliferation, spermatogenesis of the epididymis were observed at 300 mg/kg bw and cell infiltration of the epididymis at 1000 mg / kg However, since it is low frequency expression, it was not considered to be influence of the test substance.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effect on estrous cycle were observed in treated female rats as compared to control.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, delivery index, purturition or maternal behavior in treated rats.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive performance
- Remarks on result:
- other: No effects were observed
Target system / organ toxicity (P0)
- 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
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were observed in treated male and female pups as compared to control.
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on survival of treated pups were observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on offspring body weight were observed
- 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:
- no effects observed
- Description (incidence and severity):
- No external changes were observed in offspring
- Histopathological findings:
- not specified
- Other effects:
- not specified
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:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: No effect observed
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:
- NOAEL was considered to be 1000 mg/kg bw when Crj: CD (SD) male and female rats were treated with 2-Amino-5-methylbenzenesulfonic acid orally by gavage for 48 days.
- Executive summary:
In a Preliminary Reproduction Toxicity Screening Test, Crj: CD(SD) male and female rats were treated with 2-Amino-5-methylbenzenesulfonic acid in the concentration of 0 (vehicle), 100, 300, 1000 mg/kg/day orally by gavage in Sesame oil. Ocular secretion in 100 mh/kg bw, hair loss in 300 and 1000 mg/kg bw were observed in male rats and hair removal was observed in the 100 mg / kg group through pregnancy and nursing periods, and in the control group of female rats. No change due to administration of the test substance was observed. No mortality and change in body weight were observed as compared to control. Statistically significant increase in food consumption from 1 to 15 days of administration in male rats at 1000 mg/kg bw and no effect on female rats were observed. In addition, statistically significant decrease in epididymis weight was observed at 300 mg/kg bw but there was no difference in the relative weight, and a similar change was observed in the 1000 mg / kg group There was not. There was no difference between the control group and each test substance administered group as testicular weight. No gross pathological change was observed in treated rats. Seminiferous tubular atrophy of the teste, testicular and epididymal atrophy, stromal cell proliferation, spermatogenesis of the epididymis were observed at 300 mg/kg bw and cell infiltration of the epididymis at 1000 mg / kg However, since it is low frequency expression, it was not considered to be influence of the test substance. Similarly, No effect on estrous cycle, copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, delivery index, purturition or maternal behavior in treated rats. No clinical signs, mortality and change in body weight were observed as compared to control. Therefore, NOAEL was considered to be 1000 mg/kg bw when Crj: CD (SD) male and female rats were treated with 2-Amino-5-methylbenzenesulfonic acid orally by gavage for 48 days.
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