Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-837-6 | CAS number: 88-51-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline used. A reliability of 2 is assigned for read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- 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-methylbenzenesulfonic acid
- Details on test material:
- Mitsuboshi Chemical Co., Ltd.: purity >99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
age: 5 weeks
weight at initiation: 168-183 g for males, 138-162 g for females
pellet food and water: free take
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil
- Details on oral exposure:
- Application volume: 5ml/kg bw
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days exposure, 14 days recovery period
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 and 1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 14 days for 0 mg/kg and 1000 mg/kg group
Examinations
- Observations and examinations performed and frequency:
- clinical signs and mortality: every day
body weight: twice a week, total 9 times during the 28 days, and additional 4 times during the 14 days recovery period
food consumption: once a week (24hr consumption)
water consumption: not checked
Hematology: checked
Clinical Chemistry: checked
Organ weights: checked
Results and discussion
Results of examinations
- Details on results:
- PRELIMINARY EXAMINATION
Four males and four females were used for the 14-day preliminary examination. No toxicological effects in the clinical signs, body weight, food consumption, urinary findings, hematological findings, blood chemical findings and weight of organs were seen up to 2000 mg/kg bw/day. At necropsy enlargement of cecum was observed in all animals at 2000 mg/kg bw/day group.
MORTALITY AND CLINICAL SIGNS
Neither mortality nor changes in behaviour were observed in any groups.
BODY WEIGHT AND FOOD CONSUMPTION
No toxic effects on body weight and food consumption were observed in any groups.
URINALYSIS
Increase in specific gravity and decrease in pH were observed in males treated with 1000 mg/kg bw/day. However no related change was observed in other findings.
HEMATOLOGY AND CLINICAL CHEMISTRY
Slight decreases in white blood cell count (due lymphopenia) were reported for the males of the 1000 mg/kg bw/day group.However, no pathological changes were observed in the lymphatic tissues (e.g. thymus, lymph node and spleen).
Slight increases in GPT in females, slight decreases in total cholesterol in males and slight decreases in glucose in females were observed in the 1000 mg/kg bw/day group. However, no pathological changes could be noticed in any of the related organs including the liver. According to the author, the changes were within normal range, based on other study data.
NECROPSY
Slight enlargement of cecum was seen in one male and one female of the 1000 mg/kg bw/day group. However neither diarrhea nor growth abnormalities had been reported.
Referring to organ weights, decreases in thymus weight at 100 mg/kg bw/day and increases in spleen weight at all dose levels in females were observed. However these changes showed no dose level-relationship.
REVERSIBILITY
All of the changes reported above returned to normal during the 14 days recovery period.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Reversible and slight effects in hematology, clinical chemistry and gross necropsy
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Toxicological effects included decreases in white blood cell count, total cholesterol and urine pH, and enlargement of cecum in male at 1000 mg/kg bw/day; increases in GPT, decreases in glucose and enlargement of cecum in female at 1000 mg/kg bw/day. Since all findings were reversible within 14 days, the NOEL can be set at 300 mg/kg bw/day for both sexes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.