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EC number: 245-821-7 | CAS number: 23680-84-4
- 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:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- 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:
- Combined Repeat Dose and Reproductive / Developmental Toxicity Screening Test of 2-Amino-1-naphthalenesulfonic acid by Oral Administration in Rats
- 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:
- Combined repeated dose repro-devp. Screen was performed for the test chemical 2-Amino-1-naphthalenesulfonic acid to evaluate its toxic nature upon repeated application by the oral route of exposure.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-aminonaphthalene-1-sulphonic acid
- EC Number:
- 201-331-5
- EC Name:
- 2-aminonaphthalene-1-sulphonic acid
- Cas Number:
- 81-16-3
- Molecular formula:
- C10H9NO3S
- IUPAC Name:
- 2-aminonaphthalene-1-sulfonic acid
- Reference substance name:
- 2-Amino-1-naphthalenesulfonic acid
- IUPAC Name:
- 2-Amino-1-naphthalenesulfonic acid
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material: 2-Amino-1-naphthalenesulfonic acid
- Molecular formula: C10H9NO3S
- Molecular weight: 223.2511 g/mol
- Substance type: Organic
- Physical state: Yellowish white to very light red solid
- Impurities: Purity: 98.9%
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material: 2-Amino-1-naphthalenesulfonic acid
- IUPAC name: 2-Amino-1-naphthalenesulfonic acid; 2-aminonaphthalene-1-sulfonic acid
- Molecular formula: C10H9NO3S
- Molecular weight: 223.2511 g/mol
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- other: Crj: CD (SD), (SPF)
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Japan Hokkaido Center, Charles River Japan Co., Ltd.
- Age at study initiation: 9 week and 5 days
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: During the quarantine / acclimation period, stainless steel suspended cages were used to keep up to 5 groups per cage, and after grouping they were individually raised using a stainless steel 5 cage
- Diet (e.g. ad libitum): CRF-1,
Oriental Yeast Industry Co., Ltd. Ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period:
Acclimation period: 7 days
Quarantine period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 ° C
- Humidity (%): 40 to 70%
- Air changes (per hr): 12 times / hour
- Photoperiod (hrs dark / hrs light): bright and dark each for 12 hours
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: Test sample solution was prepared by suspending the test substance in 0.5% CMC aqueous solution.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): 0.5% CMC aqueous solution
- Concentration in vehicle: 0, 8, 40, 200 or 1000 mg/Kg bw
- Amount of vehicle (if gavage): 5 mL/Kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test substance concentration in each administration sample solution was measured by HPLC method in the test facility twice before administration and before the administration period.
- Duration of treatment / exposure:
- The administration period was 49 days in males for the total of 49 days before mating and for 35 days thereafter in the female, 14 days before mating in the female, during the mating period (maximum 8 days), the day before the pregnancy period and 4th day of autopsy on the 4th day of nursing (41 to 48 Days).
- Frequency of treatment:
- Daily, Once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 8, 40, 200 or 1000 mg/Kg bw
Basis:
- No. of animals per sex per dose:
- Total: 120
0 mg/Kg bw: 12 male and 12 female
8 mg/Kg bw: 12 male and 12 female
40 mg/Kg bw: 12 male and 12 female
200 mg/Kg bw: 12 male and 12 female
1000 mg/Kg bw: 12 male and 12 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Details on study design
- Dose selection rationale: As a result of preliminary test (oral administration: 0, 30, 100, 300 and 1000 mg / kg, 5 groups per group) for oral administration for 2 weeks for setting dose using male rats, 1000 There was no mortality in the mg / kg group, and no abnormalities were observed in general condition, weight shift and necropsy.
- Rationale for animal assignment (if not random): The grouping was performed on the day before the administration start date so that the average body weight and dispersion of each group were almost equal by random sampling method after separating body weight by stratum.
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: During the administration period, observation was made twice before and after administration daily
- Cage side observations checked in table [No.?] were included. Clinical signs and mortality
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations:
Males:Twice per week and measured on autopsy day
Females:Twenty four days before the mating and twice weekly during the mating period, gestation on 0, 7, 14 and 21 gestation during pregnancy, and during nursing at 0 and 4 days of feeding, respectively
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,
Males:
After 14 days before the start of the mating and after the end of the mating period, the amount was measured twice a week for 2 consecutive days and converted into the daily dose. From the evening of the day before necropsy it was fasted.
Females:
For 14 days before the start of the mating, the amount was measured twice a week for 2 consecutive days and converted into the daily dose. During the pregnancy period, cumulative amounts for 0, 4, and 11 days of gestation were measured for 2 consecutive days from the 0th, 7th, 14th, and 19th gestation days, respectively, and converted into the daily amount, respectively.
- 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: Males: on the day after the final administration
- Anaesthetic used for blood collection: Males: Yes, sodium pentobarbital
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Males: Prothrombin time (PT), activated partial thromboplastin time (APTT) and fibrinogen concentration were determined
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Males: on the day after the final administration
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined.
Males: GOT and GPT , γGTP , total protein (TP), urea nitrogen (BUN) , creatinine Jaff , total bilirubin (T-Bil) , glucose, inorganic phosphorus (IP) by Molybdenum blue method and Ca. Na and K, and Cl were also measured. The amount of albumin was calculated.
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
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,
Males: Gross observation of organs and tissues was conducted after further exsanguination by exsanguinating the animals collected. After removing the liver, kidney, thymus, testis and epididymis, the weight was measured, and the adrenal glands, brain, heart and spleen were further excised.
HISTOPATHOLOGY: Yes,
Males: testis and epididymis were fixed in Bouin's solution, and other organs / tissues were fixed in 10% neutral buffered formalin solution.
Male/Female: Paraffin embedded specimens were prepared for each organ and tissue in all fixed cases according to a conventional method. For the control group and 1000 mg / kg group, HE stained tissue specimens were prepared and histopathologically examined. - Other examinations:
- Females:
Sex cycle:
Every day from observation start date to mating confirmation day was observed once. In addition, when the estrus period was observed for 2 consecutive days, it was counted as 1 time.
Observation of delivery status: After daily observation up to 4th day of nursing, on day 4 of nursing exsanguinated by ether anesthesia from the abdominal aorta, necropsy was done and the number of lesion traces and corpus luteums were counted. The liver, kidney, thymus and ovary were excised and weighed and fixed in 10% neutral buffered formalin solution together with adrenal glands, brain, heart and spleen.
Treatment of mother animals whose whole newborn died:
Including a maternal animal in which all newborns died [including those in the case of stillborn infants (1 case of 8 mg / kg group)] was found
to be bleeding from the abdominal aorta immediately under ether anesthesia and necropsied, The number and corpus luteum number were
counted. The liver, kidney, thymus and ovary were excised and weighed and fixed in 10% neutral buffered formalin solution together with adrenal glands, brain, heart and spleen.
Male and female in the same group of approximately 12 weeks old, to whom the test substance was administered over 14 days, were mated
together in a one to one
combination. The mating period was set as continuous living crossing until confirmed mating up to the 14th day, but mating of all cases was confirmed by 8th day after living together. The mating confirmation went at almost a fixed time every morning. A female whose sperm or vaginal plug was confirmed in the vaginal plaque was regarded as a copulating animal and the day was counted as the 0th day of pregnancy. - Statistics:
- The statistical method of the measured value was the multiple comparison test and chi square test, and the significant difference test was carried out between the control group and each administration group of the test substance. In any of the tests, less than 5% of significance level was considered significant, and it was divided into less than 5% (p <0.05) and less than 1% (p <0.01). The newborn baby set the average of one stomach as one unit.
Multiple comparison test:
Weight, food consumption, number of estrous cycles, number of copulation days, pregnancy period, implantation number, number of corpus
luteums, implantation rate, total number of births, number of stillbirths, delivery rate, birth rate, survival rate on 4th day of nursing, number of neonates , Sex ratio, appearance rate of outer table abnormality, organ weight (absolute weight and relative weight), hematology examination results and blood biochemical examination results.
In the test, we test homodispersity by the Bartlett method, perform variance analysis by the one way
method in the case of equal variance, and if significant, compare the intergroup
comparison with the control group by the Dunnett method (if the number is equal) or Scheff was carried out by method (if the number of cases is not equal). On the other hand, when it is not recognized as equal variance, the analysis by oneway
method using the ranking (Kruskal Wallis test) is carried out, and if it is significant, the intergroup comparison with the control group is done by
the Dunnett method or Scheff Method.
Chi square test:
Mating rate, conception rate and birth rate
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality
Clinical signs:
No abnormal symptoms were observed in the control group and the administration group of 200 mg / kg or less.
Males: In the 1000 mg / kg group, salivation was observed after administration in 1 to 12 animals until the final administration day after 7th day of administration. This symptom was seen from 2 to 3 minutes after administration but disappeared about 10 minutes after administration. No other abnormal symptoms were observed.
Females: In the 1000 mg / kg group, salivation was observed in 0 to 6 cases after 7 days of administration before the mating, 3 to 12 cases during
gestation period, and salivation after administration in all cases during the feeding period. This symptom was seen from 2 to 3 minutes after administration but disappeared about 10 minutes after administration.
Body weight and weight gain: No significant changes were noted
Food consumption and compound intake
Males: There was no significant difference between the control group and the 1000 mg/kg group except that a significant high level was observed on the 6th day of administration.
Females: No significant changes were noted
Food efficiency: No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination: No data available
Haematology Males: No significant changes were noted
Clinical chemistry
Males: In the 1000 mg / kg group, total bilirubin showed a significant high value as compared with the control group. The other test items were almost the same as those of the control group in each administration group, and no significant difference was observed.
Urinanalysis: No data available
Neurobehaviour: No data available
Organ weights
Males: In the 1000 mg / kg group, absolute liver weight and relative weight were both significantly lower than the control group. There was no significant difference between any organ weight and the control group in the administration group of 200 mg / kg or less.
Females: No significant changes were noted
Gross pathology: No significant changes were noted
Histopathology
Males:
Liver: Very mild necrosis lesion was found in the control group and one in the 1000 mg / kg group, very slight to mild granulomas in the control group and 6 to 8 cases in the 1000 mg / kg group, very mild to mild cell collection Cough was seen in 3 to 5 cases of control group and 1000 mg / kg group.
Heart: Very mild to moderate cell infiltration was seen in the control group and 1 to 4 cases of 1000 mg / kg group.
Kidney: Very mild renal tubular basification was observed in the control group and 12 cases in the 1000 mg / kg group, with very mild cell infiltration in the control group and 12 cases in the 1000 mg / kg group. No marked changes were observed in other test sites (thymus, spleen, testis, epididymis, adrenal glands and brain).
Females:
Liver: Very mild necrosis was found in 2 of the control group.
Heart: Very mild cell infiltration was found in one case of 1000 mg / kg group.
Kidney: Very mild Ca deposition was found in the tubule in the 1000 mg / kg group.
Spleen: Very mild to moderate extramedullary hematopoiesis was found in 11-12 cases of control group and 1000 mg / kg group.
No marked changes were observed in other test sites (thymus, ovary, adrenal gland and brain).
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant changes were noted
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table: Absolute and relative organ weights of male rats in combined repeat dose and reproductive/developmental screening toxicity test of
2-amino-1-napthalenesulphonic acid bu oral administration
Group |
Control |
2-amino-1-napthalenesulphonic acid |
|||
Dose (mg/Kg) |
0 |
8 |
40 |
200 |
1000 |
Body weight (g) |
494.7±28 |
480.2± 38.2 |
493.9± 26.6 |
485.6± 21.4 |
478.2± 26.4 |
Thymus (mg) |
356.11± 82.33 |
328.28± 72.93 |
349.02± 101.54 |
290.50± 45.01 |
305.75± 91.68 |
Liver (g) |
13.097± 1.668 |
12.369± 1.334 |
13.451± 1.885 |
12.503± 1.067 |
11.477± 1.082* |
Kidney (g) |
2.953± 0.244 |
3.017± 0.222 |
2.977± 0.254 |
3.029± 0.258 |
3.032± 0.169 |
Testes (g) |
3.339± 0.164 |
3.399± 0.230 |
3.527± 0.26 |
3.322± 0.245 |
3.379± 0.141 |
Epididymides (g) |
1.271± 0.012 |
1.325± 0.122 |
1.305± 0.114 |
1.322± 0.083 |
1.279± 0.070 |
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) in Crj: CD (SD), (SPF) rats for 2-Amino-1-naphthalenesulfonic acid is considered to be 200 mg/Kg bw.
- Executive summary:
Combined repeated dose repro-devp. Screen was performed for the test chemical 2-Amino-1-naphthalenesulfonic acid to evaluate its toxic nature upon repeated application by the oral route of exposure.
The test compound was administered to Crj: CD (SD), (SPF) male and female rats at dose levels of 0, 8, 40, 200 or 1000 mg/Kg bw.
The animals were observed for clinical signs, mortality, hematological and blood chemistry parameters, changes in body weight and alteration in gross and histopathology if any.
Changes in organ weight (liver) in males and histopathological findings in females were noted at 1000 mg/Kg bw, no significant changes were noted at 200 mg/Kg bw in male and female animals. Therefore, the No Observed Adverse Effect Level (NOAEL) in Crj: CD (SD), (SPF) rats for 2-Amino-1-naphthalenesulfonic acid is considered to be 200 mg/Kg bw.
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