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EC number: 229-291-4 | CAS number: 6470-17-3
- 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
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- Auto flammability
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- 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
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- Endpoint summary
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- 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:
- screening for reproductive / developmental 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 publication
Data source
Reference
- Reference Type:
- other: Autharized database
- Title:
- Reproduction Toxicity Screening Preliminary Test of 2-Amino-5-Methylbenzenesulfonic Acid by Oral Administration in Rats
- Author:
- J-CHECK
- Year:
- 2 016
- Bibliographic source:
- Ministry of Health, Labour and Welfare", "Ministry of the Environment" and "National Institute of Technology and Evaluation, J-CHECK - (2016)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Reproduction Toxicity Screening Test of 2-Amino-5-Methylbenzenesulfonic Acid 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
- Reference substance name:
- 2- Amino-5-Methylbenzenesulfonic Acid
- IUPAC Name:
- 2- Amino-5-Methylbenzenesulfonic Acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): 2- Amino-5-Methylbenzenesulfonic Acid
- Molecular formula (if other than submission substance): C7H9NO3S
- Molecular weight (if other than submission substance): 187.2181g/mole
- Substance type: Organic
- Physical state: fine yellowish white powder
- Impurities (identity and concentrations): 0.7 %
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2- Amino-5-Methylbenzenesulfonic Acid
- Molecular formula (if other than submission substance): C7H9NO3S
- Molecular weight (if other than submission substance): 187.2181g/mole
- Substance type: Organic
- Physical state: fine yellowish white powder
- Impurities (identity and concentrations): 0.7 %
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Co., Ltd. (Kanagawa)
- Age at study initiation: 10 weeks
- Weight at study initiation: 375 to 414 g in males and 239 to 266 g in females
- Fasting period before study: No data available
- Housing: Individual housed in an aluminum front and floor stainless steel mesh breeding cage in a breeding room. Maternal animals after gestation day 18 were kept on an aluminum front and floor stainless steel mesh breeding cage with nursery until nursing 4th.
- Diet (e.g. ad libitum): NMF solid feed (radiation sterilized feed) manufactured by Oriental Yeast Co., Ltd., and was taken free during the breeding period.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2 ° C
- Humidity (%): 55 ± 10%
- Air changes (per hr): Ventilation frequency of 15 times / hour,
- Photoperiod (hrs dark / hrs light): 12 hours (7 am lights, 7 pm off)
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- silicone oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Administration solution, which was prepared by suspending the pharmacopoeial sesame oil (Miyazawa Pharmaceutical), was sealed stored under the cold shielding until use. Test substance drug substance and administration solution of the test substance was confirmed to be stable.
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0,100 ,300 and 1000 mg/kg/bw/day
- Amount of vehicle (if gavage): 0.5 ml per body weight 100 g.
- Lot/batch no. (if required): No data available.
- Purity: - Details on mating procedure:
- - M/F ratio per cage: 1;1
- Length of cohabitation: 14 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy Sperm confirmation in vaginal plaque, and that day was taken as the 0 day of pregnancy. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- For the analysis of the concentration and homogeneity of the administration solution, samples were randomly extracted from batches of each group prepared at the start of preparation. As a result, the error with respect to the display density was in the range of 12.5 to 0.4% and within the reference range (within ± 15%). Therefore, it was confirmed that a prescribed amount of 2amino5methylbenzenesulfonic acid was contained in the administration liquid used.
- Duration of treatment / exposure:
- Male: 48 days
Female: 69 days - Frequency of treatment:
- Daily (Once)
- Details on study schedule:
- - Dose selection rationale: A 14 days repeated oral toxicity Study was observed in 1 group 4 males and 4 females, and the 0,100,250,500,1000 and 2000 mg / kg / day dose was administered for 14 day daily by oral gavage. General state, body weight, food consumption, urinalysis, hematology testing, in the blood biochemical examination and organ weight, suggest change the toxicity of the test substance was observed. In the autopsy, the cecum of expansion was observed in male and female in all cases of 2000 mg / kg group. Therefore the final dose selected for this study was 100, 300 and 1000 mg/kg/bw/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:
- Total no of animals 96
0 mg/kg/bw/day- 12 male, 12 female
100 mg/kg/bw/day - 12 male, 12 female
300 mg/kg/bw/day - 12 male, 12 female
1000 mg/kg/bw/day – 12 male, 12 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Survival, clinical sign, Body weight and Food intake was observed.
- Oestrous cyclicity (parental animals):
- Copulation formation, average season cycle, number of days between the estrus period and the next estrus period as the sex cycle days and mating rate were examined.
Corpus luteums, number of implantation traces were examined. - Sperm parameters (parental animals):
- No data available
- Litter observations:
- Number of births, sex, body weight of 0 and 4 days were examined.
- Postmortem examinations (parental animals):
- Organ weight, gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- Gross abnormalities of organs and tissues were observed.
- Statistics:
- Weight, food intake, 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 24)
was performed on the survival rate, organ weight and relative weight of the rats.
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, the average for one newborn baby during the nursing period was taken as one sample. The level of significance was set at two levels of *: P <0.05 and **: P <0.01. - Reproductive indices:
- Pregnancy period, Implantation rate, delivery rate, live birth rate, mating rate were examined.
- Offspring viability indices:
- Viability on day 4 were examined.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were observed in treated male and female rats due to treatment as compared to control.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No effect on survival of treated male and female rats was observed as compared to control.
In male rats, ocular secretion in 1 rat at 100 mg / kg, hair loss in 1 rat at 300 mg / kg and Crust and hair loss were observed in 1 in case at 1000 mg / kg.
In female rats, hair removal was observed in 100 mg / kg group through pregnancy and nursing periods, and in the control group, all the dead animals were found in 2 cases. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant effect on body weight and body weight gain was observed in treated male rats as compared to control.
In female rats, at 100 and 1000 mg / kg, statistically significant decrease in body weight only at 4th day of nursing was observed as compared to the control.
However, since there was no obvious difference on the other measurement days and it was a change only for 1 day, and since there was no obvious change in body weight gain during the nursing period, the influence of administration of the test substance It was not thought to be an accidental change. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- In male rats, statistically significant increase in food consumption from 8 to 15 days cumulative food intake from 1 to 15 days were observed at 1000 mg / kg bw.
In female rats, no significant effect was observed as compared to control. - 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):
- In male rats, one case skin erosion and squamous epithelium hyperplasia and cell infiltration of epididymis at 1000 mg / kg, seminiferous tubular, testicular and epididymal atrophy of testes, stromal cell proliferation, spermatozoa of epididymis, lung inflammation and liver necrosis at 300 mg / kg were observed.
However, since it is low frequency expression, it was not considered to be influence of the test substance.
In female rats, 1 case of the lung inflammation, 1 case of the stomach ulcer, 1 part of the adrenal cortex and atrophy of the thymus at 1000 mg/kg bw, 1 case of atrophy of the thymus at 300 mg/kg bw and Young yolk sac cysts in one case, inflammatory infiltration of the skin and squamous epithelium proliferation were observed in one at 100 mg/kg bw, spontaneously delivered, so it was considered that there was no effect on the ovaries of the test substance.
Atrophy of the thymus and purulent inflammation of the uterus were observed in one case in all the dead animals. No abnormal findings were observed in the other case. - 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 was observed in treated rats as compared to control.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on number of corpus luteums, number of implantation traces, number of births and number of stillborn were observed in treated rats as compared to control.
Gestation index, Implantation rate, delivery rate, live birth rate and mating rate of treated rats as compared to control.
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: No effect on Survival, clinical sign, Body weight and Food intake, reproductive performance, organ weight, gross pathology and histopathology
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: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P1)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (P1)
- 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:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on number of live pups was observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of pups was observed as compared to control.
- 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 gross pathological changes were observed in pups as compared to control.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- Renal pelvic enlargement in 1 case, renal pelvic enlargement in the kidney It was recognized in 1 and 3 cases in control and 300 mg / kg respectively. In both cases, the expression was expressed in a few cases, which was not related to the administration of the test substance.
- 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:
- mortality
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- 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
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (F2)
- 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
Any other information on results incl. tables
Absolute and relative organ weight of rats treated orally with 2-Amino-5-methylbenzenesulfonic acid in the preliminary reproduction toxicity screening test.
Dose levelmg/kg/day |
0 |
100 |
300 |
1000 |
Male No. of animals examined |
12 |
12 |
12 |
12 |
Body weight(g) |
542±33 |
554±45 |
534±36 |
546±3 |
Absolute organ weight |
|
|
|
|
Testes (g) |
3.62±0.31 |
3.65±0.44 |
3.28±0.59 |
3.70±0.23 |
Epididymides(mg) |
1313±98 |
1295±138 |
1168±121* |
1316±115 |
Relative organ weight |
|
|
|
|
Testes (g %) |
0.671±0.074 |
0.664±0.094 |
0.616±0.119 |
0.680±0.666 |
Epididymides (mg %) |
243.378±27.682 |
235.898±34.456 |
219.293±27.989 |
242.189±27.983 |
Values are expressed as Mean±SD
Significant difference from control group*P<0.05
Summary of reproductive performance in rats treated orally with2-Amino-5-methylbenzenesulfonic acid in the preliminary reproduction toxicity screening test
Dose levelmg/kg/day |
0 |
100 |
300 |
1000 |
No. of pairs mated |
12 |
12 |
12 |
12 |
No. of pairs copulated |
12 |
12 |
12 |
12 |
No. of pregnant female |
11 |
10 |
12 |
12 |
Copulation index%a |
100.0 |
91.7 |
100.0 |
100.0 |
Fertility index %b |
91.7 |
90.9 |
100.0 |
100.0 |
Estrus cycle( days ,Mean±SD) |
4.5±0.7 |
4.2±0.5 |
4.2±0.4 |
4.5±0.5 |
a-No. of animals with successful copulation/No. of animals mated) X100
b-No. Of pregnant animals/ No. of animals with successful copulation X 100
Values in parentheses are expressed no. of animals observed
Finding of delivery in dams treated orally with -Amino-5-methylbenzenesulfonic acid and observation on their pups(F1) in the preliminary reproduction toxicity screening test
Dose level mg /kg/day |
0 |
100 |
300 |
1000 |
|
No. of dams observed |
11 |
10 |
12 |
12 |
|
No. of dams delivered live pups |
11 |
10 |
12 |
12 |
|
Duration of gestation (Mean±SD) |
22.7±0.6 |
22.4±0.5 |
22.3±0.5 |
22.7±0.4 |
|
No. of Corpora lutea(Mean±SD) |
216 |
170 |
218 |
222 |
|
No. of total implants(Mean±SD) |
188 |
161 |
186 |
175 |
|
No of total implants(Mean±SD) |
172 |
150 |
178 |
160 |
|
No. of total pups born(Mean±SD) |
168 |
150 |
178 |
160 |
|
Male |
81 |
69 |
91 |
79 |
|
Female |
87 |
81 |
87 |
81 |
|
Sex ratio (male and female) (Mean±SD) |
1.00 |
0.93 |
1.13 |
1.21s |
|
No of total live pups on days 4(Mean±SD) |
|
|
|
|
|
Male |
66 |
66 |
85 |
78 |
|
Female |
66 |
77 |
80 |
79 |
|
No. of total dead pups born(Mean±SD) |
4 |
0 |
0 |
0 |
|
Still birth |
0 |
0 |
0 |
0 |
|
Cannnitelism |
4 |
0 |
0 |
0 |
|
Gestation index(Mean±SD)a |
100 |
100 |
100 |
100 |
|
Implantation index(Mean±SD)b |
89.5±12.3 |
94.7±2.0 |
86.6±15.8 |
80.2±18.2 |
|
Delivery index(Mean±SD)c |
91.6±5.6 |
93.5±7.7 |
96.2±4.8 |
90.9±8.6 |
|
Live birth index(Mean±SD)d |
97.4±8.6 |
100±0 |
100±0 |
100±0 |
|
Viability index on day 4(Mean±SD)e |
|||||
Male |
77.8±39.1 |
96.08.4 |
93.1±9.7 |
99.1±3.2 |
|
Female |
77±39.1 |
95.7±5.6 |
94.4±15.8 |
98±4.8 |
|
a-(No of females with live pups/ No. of pregnant females) x100
b-( No of implants/No. of corpora lutea)x100
c-(( No .of pups born/No. of implants)X100
d.(No. of live pups born / No. of pups born)x100
e.-No. of live pups on day4 after birth/No. of live pups born)X100
(Includes live pups died before observation)
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw for P and F1 generation when Crj: CD (SD) male and female rats were treated with 2- Amino-5-Methylbenzenesulfonic Acid orally by gavage in Sesame oil for 69 days.
- Executive summary:
In a reproductive toxicity study,Crj: CD (SD) male and female rats were treated with2- Amino-5-Methylbenzenesulfonic Acid in the concentration of0, 100, 300 and 1000 mg/kg/bw/day orally by gavage in Sesame oil. No effect on survival of treated male and female rats were observed. In amle rats, ocular secretion in 1 rat at 100 mg /kg, hair loss in 1 rat at 300 mg /kg and Crust and hair loss were observed in 1 in case at 1000 mg/kg. In female rats, hair removal was observed in 100 mg/kg group through pregnancy and nursing periods, and in the control group, all the dead animals were found in 2 cases. No clinical signs were observed in treated male and female rats due to treatment as compared to control.In female rats, at 100 and 1000 mg / kg, statistically significant decrease in body weight only at 4th day of nursing was observed as compared to the control. However, since there was no obvious difference on the other measurement days and it was a change only for 1 day, and since there was no obvious change in body weight gain during the nursing period, the influence of administration of the test substance It was not thought to be an accidental change.In male rats, statistically significant increase in food consumption from 8 to 15 days cumulative food intake from 1 to 15 days were observed at 1000 mg / kg bwandin female rats, no significant effect was observed as compared to control. Similarly, no reproductive toxic effect were observed onestrous cycle, corpus luteums, number of implantation traces, number of births and number of stillborn, gestation index, implantation rate, delivery rate, livebirth rate and mating rate of treated rats as compared to control. In addition,statistically significant decrease in absolute weights of epididymiswere observedin male rats but no effect on relative weight of epididymis were observed at 300 and 1000 mg/kg bw as compared to contorl.No significant changes were observed intesticular weigth of treated male rats as compared to control. In male rats, black lesions on lung in 1 animal, red spots of the liver, testis, epididymis and thinning of the coat in 1 case of the same individual gropue were observed at 300 mg/kg bw and thinning of the coat 1 case of the same individual gropue were observed at 1000 mg/kg bw. In female rats, black spots in lungstomach ulcers and white spots of the adrenal glands in 1 case each at 1000 mg/kg bw and ovary cyst and coat thinning were observed in 1 case each at 100 mg/kg bw. No findings that could be attributed to administration of the test substance were observed in any of the animals. In male rats, one case skin erosion and squamous epithelium hyperplasia and cell infiltration of epididymis at 1000 mg / kg, seminiferous tubular, testicular and epididymal atrophy of testes, stromal cell proliferation, spermatozoa of epididymis, lung inflammation and liver necrosis at 300 mg / kg were observed. However, since it is low frequency expression, it was not considered to be influence of the test substance. In female rats, 1 case of the lung inflammation, 1 case of the stomach ulcer, 1 part of the adrenal cortex and atrophy of the thymus at 1000 mg/kg bw, 1 case of atrophy of the thymus at 300 mg/kg bw and Young yolk sac cysts in one case,inflammatory infiltration of the skin and squamous epithelium proliferation were observed in one at 100 mg/kg bw, spontaneously delivered, so it was considered that there was no effect on the ovaries of the test substance. Atrophy of the thymus and purulent inflammation of the uterus were observed in one case in all the dead animals. No abnormal findings were observed in the other case. Therefore, NOAEL was considered to be 1000 mg/kg bw for P and F1 generation when Crj: CD (SD) male and female rats were treated with2- Amino-5-Methylbenzenesulfonic Acid orally by gavage inSesame oil for 28 days.
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