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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-387-0 | CAS number: 68083-38-5
- 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:
- 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
Reference
- Reference Type:
- other: J check
- Title:
- 28 days repeated oral toxicity study for 7-Amino-4-hydroxy-2-naphthalenesulfonic acid
- Author:
- National Institute of Technology and Evaluation
- Year:
- 2 016
- Bibliographic source:
- J check, 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- 28 days repeated oral toxicity study was performed for the test compound 7-Amino-4-hydroxy-2-naphthalenesulfonic acid using rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 7-amino-4-hydroxynaphthalene-2-sulphonic acid
- EC Number:
- 201-718-9
- EC Name:
- 7-amino-4-hydroxynaphthalene-2-sulphonic acid
- Cas Number:
- 87-02-5
- Molecular formula:
- C10H9NO4S
- IUPAC Name:
- 7-Amino-4-hydroxy-2-naphthalenesulfonic acid
- Details on test material:
- - Name of test material : 7-Amino-4-hydroxy-2-naphthalenesulfonic acid
- Molecular formula: C10H9NO4S
- Molecular weight: 239.25 g/mol
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : 7-Amino-4-hydroxy-2-naphthalenesulfonic acid
- Molecular formula: C10H9NO4S
- Molecular weight: 239.25 g/mol
- Substance type: Organic
- Physical state: Grey white powder
- Impurities: 91.8% pure
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc
- Age at study initiation: 6 weeks old
- Weight at study initiation:
Males: 208.4 to 228.6 g
Females: 137.6 to 165.0 g
- Fasting period before study:
- Housing: Animals were placed in a stainless steel hanger cages. 3 rats were housed together during the quarantine period and then housed individually during the study period.
- Diet (e.g. ad libitum): High pressure steam sterilized solid feed (MF, Oriental Yeast Industry
Co., Ltd.)
- Water (e.g. ad libitum): water added with sodium hypochlorite added (about 2 ppm)
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2 ° C
- Humidity (%): 55 ± 10%
- Air changes (per hr): ventilation times of 13 / hour
- Photoperiod (hrs dark / hrs light): lighting time of 7 to 19 h
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- other: 5% aqueous gum arabic solution
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance was suspended at concentrations of 2.5, 5 and 10 w / v% in the vehicle to prepare a solution.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): 5% aqueous gum arabic solution
- Concentration in vehicle: 0, 250, 500 or 1000 mg/Kg bw
- Amount of vehicle (if gavage): 10mL/kg
- Lot/batch no. (if required): PTG 0424
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- 0, 250, 500 or 1000 mg/Kg bw
- No. of animals per sex per dose:
- Total: 96
0 mg/Kg bw: 12 male and 12 female
250 mg/Kg bw: 6 male and 6 female
500 mg/Kg bw: 6 male and 6 female
1000 mg/Kg bw: 12 male and 12 female
Recovery group:
0 mg/Kg bw: 6 male and 6 female
1000 mg/Kg bw: 6 male and 6 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose was set from the results of preliminary test (dose: 0, 250, 500 and 1000 mg / kg) by repeated administration for 2 weeks. That is, since no toxicity was expressed by the test substance even at the dose of 1000 mg / kg in the test, the dose in this study was 1000 mg / kg as a high dose according to the guidelines of the Chemical Substitution Law, and 500 and 250 Mg/ kg in total 3 doses were set.
- Rationale for animal assignment (if not random): The grouping was carried out by stratified continuous randomization method based on the body weight on the day before starting the administration.
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: Yes
- Section schedule rationale (if not random): No data - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: During the administration period, the general condition and the presence or absence of death were observed twice in total, twice a day before and after administration and twice in the morning and afternoon every day during the recovery period.
- Cage side observations checked in table [No.?] were included. General condition, mortality
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Twice weekly during the administration period and recovery period.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, Twice weekly during the administration period and recovery period.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At the end of the administration period and at the end of the recovery period
- Anaesthetic used for blood collection: Yes, pentobarbital sodium anesthesia
- Animals fasted: No data
- How many animals: 6/dose
- Parameters checked in table [No.?] were examined. the number of white blood cells, the number of red blood cells, The amount of hemoglobin, the hematocrit value and the number of platelets were measured, and the average red blood cell volume (MCV), the average red blood cell hemoglobin amount (MCH ) and average red blood cell hemoglobin concentration (MCHC) were calculated. Furthermore, 3.8% sodium citrate added blood was centrifuged at 3000 rpm for 15
minutes, and the plasma obtained was used to perform a total automatic blood coagulation measurement time and activated partial thromboplastin time were measured.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At the end of the administration period and at the end of the recovery period
- Animals fasted: No data
- How many animals: 6/dose
- Parameters checked in table [No.?] were examined. Total protein, albumin, A / G ratio, total bilirubin, GOT, GPT, glutamyl transpeptidase, alkaline phosphatase, total cholesterol, triglyceride, phospholipids, glucose , urea nitrogen, creatinine, inorganic phosphate And calcium were measured. Sodium, potassium, and crawl were measured.
URINALYSIS: Yes
- Time schedule for collection of urine: On the 4 th week of administration and 2 weeks of recovery
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked in table [No.?] were examined. PH, protein, glucose, ketone bodies, bilirubin, occult blood, and urobilinogen were examined. Further, fresh urine was centrifuged at 1,500 rpm for 5 minutes and the obtained urine sediment was microscopically examined. In addition, urine volume, color tone, osmotic pressure and specific gravity was also measured.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organ weight (absolute weight) was measured by removing brain, heart, lung (including bronchus), thymus, liver, spleen, kidney, adrenal glands, testis and ovaries, and the body weight ratio on the day of necropsy. Relative organ weight was also calculated.
HISTOPATHOLOGY: Yes, in addition to the organs tested for gross pathology, hypophysis, spinal cord, eyeball, thyroid (including parathyroid gland), pancreas, stomach, bladder, femur (including bone marrow) and macroscopic abnormal sites were collected and resuspended in 10% neutral buffered formalin The solution was fixed with a solution (glutaraldehyde solution for eyeballs, prefixed with Bouin solution for testis). - Other examinations:
- No data
- Statistics:
- The mean value and standard deviation were determined for each group for body weight, food intake, urinalysis (excluding
qualitative reaction), hematology examination, blood biochemical examination, organ weight and organ weight ratio, for each group, Homogeneity was tested. If the variance is uniform, a one-way analysis of variance was performed, and when a significant difference was observed between the groups in this analysis, a pairwise comparison test of each group was performed by the Dunnett method. When the variance is not uniform, a rank test is performed by the Kruskal-Wallis method. In the case where a significant difference is observed between the groups in this test, a pairwise comparison test of the Dunnett type was performed. When there was no significant difference between the groups by the variance analysis described above or the rank test by the Kruskal-Wallis method, multiple comparison between each group was not carried out. In both cases, the significance level was set at 5%.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 4 weeks of dosing, loss of the maxillary incisor tip was observed in one male in the 1000 mg / kg group, but it was considered to be an accidental change. In addition to this there was no change in general condition.
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was noted
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant difference between the control group and each administration group throughout the administration period and recovery period was noted
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- A transient increase in food intake was observed in males of the 1000 mg / kg group at the 4th week of administration, but it was thought that there was minor fluctuation and was of no toxicological significance
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No significant alterations were noted
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- There was no change at the end of the administration period, and as a minor change only at the end of the recovery period, GOT increased in male at 1000 mg / kg group and calcium was decreased in female of the same group.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight rise in urine specific gravity in males at 500 mg / kg group at 4 weeks of dosing was noted.
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A decrease in the relative weight of the heart in females in all treatment groups was noted. In addition, in the 250 and 1000 mg / kg group, the absolute weight of the heart was decreased, and the same tendency was observed in the females of the 500 mg / kg group. However, these were considered to be minor fluctuations, and because there was no constant trend in the dose and the degree of change, it was considered to be an accidental fluctuation unrelated to administration.
At the end of the recovery period, there was an increase in the absolute weight of the lungs and a decrease in the relative weight of the heart in males in the 1000 mg / kg group. - Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Test group: A single grayish white spot and mild pyeloid dilatation in the right kidney was noted in one male in the 1000 mg / kg group. The same extent of renal pelvic dilation in the right kidney was also seen in 2 males in the 250 mg / kg group, and in one of them, mild atrophy of the left testis was also observed. In these histopathological examinations, renal pelvic dilation was observed in the kidneys, and 1 of them in the 1000 mg / kg group had basophilization of localized proximal renal tubular epithelium, dilation of distal tubule, and Lymphocyte infiltration into the interstitium as well as calcification of the papilla were observed. Atrophy was also confirmed in the testis by histopathological examination.
These changes were frequently observed changes in normal rats, and since their frequency of appearance was not related to the dose, it was considered that these changes were spontaneous changes. No other macroscopic and histopathological changes were observed at the end of the administration period.
Recovery group: No changes were noted - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No data
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant alteration were noted
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound 7-Amino-4-hydroxy-2-naphthalenesulfonic acid is found to be 1000 mg/Kg bw.
- Executive summary:
28 days repeated oral toxicity study was performed for the test compound 7-Amino-4-hydroxy-2-naphthalenesulfonic acid using rats. The animals were dosed at dose levels of 0, 250, 500 or 1000 mg/Kg bw. In addition, recovery group was also included in the study at dose levels of 0 or 1000 mg/Kg bw for 14 days.There was no change due to administration in any of the general condition, body weight, food intake, urinalysis, hematology examination, blood biochemical examination, organ weight, necropsy, and histopathological examination. At 4 weeks of dosing, loss of the maxillary incisor tip was observed in one male in the 1000 mg / kg group, but it was considered to be an accidental change. In addition to this there was no change in general condition. No mortality was noted in the treated animals. No significant difference between the control group and each administration group throughout the administration period and recovery period was noted. A transient increase in food intake was observed in males of the 1000 mg / kg group at the 4th week of administration, but it was thought that there was minor fluctuation and was of no toxicological significance. There was no change at the end of the administration period, and as a minor change only at the end of the recovery period, GOT increased in male at 1000 mg / kg group and calcium was decreased in female of the same group. A slight rise in urine specific gravity in males at 500 mg / kg group at 4 weeks of dosing was noted. A decrease in the relative weight of the heart in females in all treatment groups was noted. In addition, in the 250 and 1000 mg / kg group, the absolute weight of the heart was decreased, and the same tendency was observed in the females of the 500 mg / kg group. However, these were considered to be minor fluctuations, and because there was no constant trend in the dose and the degree of change, it was considered to be an accidental fluctuation unrelated to administration. At the end of the recovery period, there was an increase in the absolute weight of the lungs and a decrease in the relative weight of the heart in males in the 1000 mg / kg group. A single grayish white spot and mild pyeloid dilatation in the right kidney was noted in one male in the 1000 mg / kg test group. The same extent of renal pelvic dilation in the right kidney was also seen in 2 males in the 250 mg / kg group, and in one of them, mild atrophy of the left testis was also observed. In these histopathological examinations, renal pelvic dilation was observed in the kidneys, and 1 of them in the 1000 mg / kg group had basophilization of localized proximal renal tubular epithelium, dilation of distal tubule, and Lymphocyte infiltration into the interstitium as well as calcification of the papilla were observed. Atrophy was also confirmed in the testis by histopathological examination. These changes were frequently observed changes in normal rats, and since their frequency of appearance was not related to the dose, it was considered that these changes were spontaneous changes. No other macroscopic and histopathological changes were observed at the end of the administration period. No changes were noted in the recovery group. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test compound 7-Amino-4-hydroxy-2-naphthalenesulfonic acid is found to be 1000 mg/Kg bw.
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.