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EC number: 201-810-9 | CAS number: 88-21-1
- 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
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- other: study report
- Title:
- "Preliminary Reproduction Toxicity Screening Test of 2-Amino- 5-methylbenzenesulfonic acid by Oral Administration in Rats".
- Author:
- Ministry of Health & Welfare, Japan
- Year:
- 1 999
- Bibliographic source:
- Toxicity Testing Reports of Environmental Chemicals, vol.7 p163-171,
- Reference Type:
- other: study report
- 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)
- GLP compliance:
- not specified
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
- IUPAC Name:
- 2-amino-5-methylbenzenesulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): 4-aminotoluene-3-sulphonic acid
- Substance type: Organic
- Physical state: Solid
Constituent 1
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): ad libitum
- Water (e.g. ad libitum): 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 / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day
Basis:
- 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 - Litter observations:
- Pups number, sex, weight by sex in each litter, appearance were observed on 0th and 4th day. Dead pups were checked separately
- 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):
- No effects was observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects was observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effects was observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-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):
- No effects were observed
Details on results (P0)
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:
- other: Effects: No effects were observed in the copulation index, fertility index, gestation length, number of corpora lutea or implanations, implanation index,gestation index, parturition or maternal behavior.
- Remarks on result:
- other: not specified
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no adversed effects was observed
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- no dose related effects was observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- no effects observed during study
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- no effects was observed
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
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:
- other: see 'Remark'
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- “No observed adverse effect level (NOAEL)” for reproductive toxicity was considered to be 1000 mg/kg bw/day.
- Executive summary:
The study was designed to investigate one generation reproductive toxicity effects of 4-aminotoluene-3-sulphonic acid on Crj: CD (SD) male and female rat by oral gavage route.Rat were treated with4-aminotoluene-3-sulphonic acid at doses of 0(vehicle), 100, 300, 1000 mg/kg/day to 12 animals per sex per dose.
There were no compound related effects on copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, parturition or maternal behavior. There were no significant differences in number of offspring or live offspring, sex ratio, the live birth index, the viability index and the body weight. No abnormal findings related to the test substance were noted for external features, clinical signs, or on necropsy finding for the offspring. No pups with malformation were found in any group. No change in clinical signs and necropsy finding were observed in offspring.
Therefore the “No observed adverse effect level (NOAEL)” for reproductive toxicity was considered to be 1000 mg/kg bw/day.
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