Name: OECD_SIDS / SUBSTANCE : Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt /70974-33-3 Fri, 16 Dec 2022, 16:08:08+0900 /Legal entity owner: National Institute of Health Sciences
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iTable of Contents
0/0 ............................................................................................................................. 1
National Institute of Health Science ..................................................................... 2
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt ......................................................... 3
1 General information .................................................................................. 3
1.1 Identification ................................................................................. 3
Identification ............................................................................... 3
Identification ...................................................................... 3
1.10 Assessment approach (assessment entities) ................................. 4
Assessment approach (assessment entities) ................................ 4
7 Toxicological information ......................................................................... 5
7.2 Acute Toxicity ............................................................................... 5
7.2.1 Acute toxicity: oral .............................................................. 5
Acute toxicity: oral.001 ........................................................ 5
7.5 Repeated dose toxicity ................................................................... 9
7.5.1 Repeated dose toxicity: oral ................................................. 9
Repeated dose toxicity: oral.001 ........................................... 9
7.6 Genetic toxicity ............................................................................ 17
7.6.1 Genetic toxicity in vitro ...................................................... 17
Genetic toxicity in vitro.001 ................................................ 17
Genetic toxicity in vitro.002 ................................................ 21
7.8 Toxicity to reproduction ............................................................... 25
7.8.1 Toxicity to reproduction ..................................................... 25
Toxicity to reproduction.001 ............................................... 25
References ................................................................................................................ 33
Reference Substances ...................................................................................... 33
70974-33-3 ................................................................................................ 33
Benzenesulfonic acid, 4-hydroxy-, tin(2+) salt .............................................. 34
Test Materials .................................................................................................. 35
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt ............................................... 35
Literatures ....................................................................................................... 36
A combined repeated-dose/reproductive-developmental toxicity study ofBenzenesulfonic acid, 4-hydroxy-, tin(2+)salt by oral administration in
rats. .......................................................................................................... 36
In Vitro Chromosomal Aberration Test of Benzenesulfonic acid, 4-hydroxy-,tin(2+)salt on Cultured Chinese Hamster Cells. ........................................... 37
Reverse Mutation Test of Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt on
Bacteria. ................................................................................................... 38
Single Dose Oral Toxicity Test of Benzenesulfonic acid, 4-hydroxy-,tin(2+)salt in Rats ...................................................................................... 39
Legal Entities ................................................................................................... 40
National Institute of Health Sciences .......................................................... 40ii

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Dossier header
Dossier submission type
Name
OECD SIDS
Versioncore 7.0
Name (given by user)

Dossier subject
Dossier subject
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt / 70974-33-3
Public nameSubmitting legal entity
National Institute of Health Science
Dossier creation date/time
Fri, 16 Dec 2022, 16:08:08+0900
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LEGAL_ENTITY: National Institute of Health
Science
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General information
Legal entity nameNational Institute of Health Science2

Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt
General information
Identification
Identification
SUBSTANCE: Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt

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Substance nameBenzenesulfonic acid, 4-hydroxy-, tin(2+)salt
Legal entity
National Institute of Health Sciences / Kawasaki / Japan

Identification of substance
Reference substance
Benzenesulfonic acid, 4-hydroxy-, tin(2+) salt / 70974-33-3
EC number

EC name

CAS number

CAS name

70974-33-3
IUPAC nameRole in the supply chain
Manufacturer
false
Importer
false
Only representativefalse
Downstream user
false

3

Assessment approach (assessment entities)
FIXED_RECORD: Assessment approach
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Toxicological information
Acute Toxicity
Acute toxicity: oral
ENDPOINT_STUDY_RECORD: Acute toxicity: oral.001

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Administrative data
Endpoint
acute toxicity: oral
Type of information
experimental study
Adequacy of study
other information
Robust study summary
false
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
other: OECD Test Guideline study under GLP condition

Data source
Reference
Single Dose Oral Toxicity Test of Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt in Rats / MHLW, Japan /study report
Data protection claimed
yes

Materials and methods
Test guideline
Qualifieraccording to guideline
Guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)5

Deviationsno
GLP compliance
yes
Test type
acute toxic class method
Limit test
yes

Test material
Test material information
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt
Specific details on test material used for the study- Name of test material (as cited in study report): Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt- Chemical structure: [C6H4(OH)SO3]2Sn- Chemical formula: C12H10O8S2Sn- Molecular weight: 465.05- Puitality: >95%
- Impurities: Benzenesulfonic acid, 2-hydroxy-, tin(2+)salt; <2% ; Benzenesulfonic acid, 2,4-hydroxy-, tin(2+)salt; <2%- Solubility: 420 mg/mL in water- Supplier: Daiwakasei Industry Co., Ltd- Physical state: White crystalline solid- Stability: Stability during the test period was confirmed by the Daiwakasei Industry Co., Ltd (May 19,2006).
- Storage condition of test material: Room temperature

Test animals
Speciesratcommon species
Strain
Crj: CD(SD)rat
Sex
femaleDetails on test animals or test system and environmental conditions
TEST ANIMALS- Source: Charles River Japan Inc.
- Age at the time of purchase: 7 weeks old- Weight at dosing: Females, 191 - 205 g- Fasting period before study: Approximately 16 hrs- Housing: One animal/cage- Diet (e.g. ad libitum): Ad libitum except fasting period for 16 hrs before
administration to 3 hrs after administration- Water (e.g. ad libitum): Ad libitum- Acclimation period: 7 - 14 days
. ENVIRONMENTAL CONDITIONS- Temperature (°C): 22.6 - 23.6
- Humidity (%): 45.6 - 62.2- Ventilation (per hr): Approximately > 12 times- Photoperiod (hrs light / hrs dark): 12/12
6Administration / exposure
Route of administration
oral: gavage
Vehiclewater
Details on oral exposure
VEHICLE- Concentration in vehicle: 3 and 20 w/v%
- Lot no.: 5K91 produced by Otsuka Pharmaceutical Factory, Inc.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.
Doses
300 and 2000 mg/kg bw
No. of animals per sex per doseFirst time of administration: 300 mg/kg bw, 3 females (animal ID No. 8, 9, 12), 2000 mg/kg bw, 3 fem
ales (animal ID No. 5, 6, 11)Second time of administration: 300 mg/kg, 3 females (animal ID No. 1, 4, 7), 2000 mg/kg bw, 3 females (animal ID No. 2, 3, 10)Control animals
noDetails on study design- Duration of observation period following administration: 14 days- Frequency of observations:
Day 1 (day of administration): within 30 minutes and 1, 2, 3, 4, 5 and 6 hrs after administration.
After Day 2: once a day- Frequency of weighing: Days 1 (before administration), 7, 14- Necropsy of survivors performed: Yes
Statistics
No

Results and discussion
Effect levels
Key result
false
Sex
female
Dose descriptor
LD50
Effect level>2000

mg/kg bw

Based onact. ingr.
Mortality
No deaths were observed at 300 and 2000 mg/kg bw
7

Clinical signs
other: Salivation was observed in one rat receiving 300 mg/kg bw just after administration. Loosestool was observed on the day of administration, and dirty nose and no-feces were observed on the 1-2 days after administration in rats receiving 2000 mg/kg bw.
Gross pathology
No effects.

Applicant's summary and conclusion
Conclusions
The LD50 value was more than 2000 mg/kg bw for female rats.
Executive summary
The acute oral LD50 of benzenesulfonic acid, 4-hydroxy-, tin (2+) salt was > 2000 mg/kg bw in female
rats based on a study conducted according to the OECD TG 423. No deaths were observed at 2000 mg/
kg bw. The substance caused transient salivation at 300 mg/kg bw, and the transient effects of dirty
nose, loose stool, and no feces at 2000 mg/kg bw.

8

Repeated dose toxicity
Repeated dose toxicity: oral
ENDPOINT_STUDY_RECORD: Repeated dose toxicity: oral.001

UUID: IUC5-bbba114e-e7d4-4069-b75d-26ba2b028116
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Administrative data
Endpoint
short-term repeated dose toxicity: oral
Type of information
experimental study
Adequacy of study
other information
Robust study summary
false
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
other: OECD Test Guideline study under GLP condition
Cross-reference
Reason / purpose for cross-reference
reference to same study
Remarks
7.8.1 Toxicity to reproduction: Toxicity to reproduction.001

Data source
Reference
A combined repeated-dose/reproductive-developmental toxicity study of Benzenesulfonic acid, 4hydrox / MHLW, Japan / study report
Data accessdata published9Materials and methods
Test guideline
Qualifieraccording to guideline
Guideline
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction /Developmental Toxicity Screening Test)
Deviationsno
GLP compliance
yes
Limit test
no

Test material
Test material information
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt

Test animals
Speciesratcommon rodent species
Strain
Crj: CD(SD)rat
Sexmale/female
Details on test animals or test system and environmental conditions
TEST ANIMALS- Source: Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation:10 weeks of age- Weight at study initiation: 340-409 g for males and 205-257 g for females- Housing: bracket-type metallic wire-mesh cages (W 250 × D 350 × H 200 mm)- Diet (e.g. ad libitum):ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period:15 days
ENVIRONMENTAL CONDITIONS- Temperature (°C):21 to 26°C
- Humidity (%): 38 to 63%- Air changes (per hr):10 to 15 times per hour
- Photoperiod (hrs dark / hrs light):12-hour lighting per day

Administration / exposure
Route of administration
oral: gavage
10Vehiclewater
Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: Test substance was dissolved in distilled water for injection.
VEHICLE- Justification for use and choice of vehicle: No data
- Amount of vehicle (if gavage): 5 mL/kg bw- Lot/batch no. (if required): No data
- Dosing volume: 5 mL/kg- Storage condition of test solution: Stored in a refrigerator
Analytical verification of doses or concentrations
yes
Details on analytical verification of doses or concentrations
Test suspensions at each concentration to be used for males in week 1 and 6 of administration wereanalyzed by the HPLC method at Bozo Research Center Inc. Results showed that the concentration of
the test article in each suspension was 94.5 to 107.5% of the nominal concentration, and both values
were within the acceptable range (concentration: percentage of the nominal concentration, 100 ±10%; C.V.: 10% or below)
Duration of treatment / exposure
All males and females without mating: 42 days
Females with mating: up to 51 days including 14 days pre-mating, mating and gestation periods anduntil day 4 of lactation
Frequency of treatment
Daily: 7 times / week
Doses / concentrations
Remarks
Doses / Concentrations:
0 (vehicle), 12, 60 and 300 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose
12 animals/sex/dose with mating (main dose group), 5 animals/sex/dose at 0 and 300 mg/kg bw/day
without mating (recovery group)
Control animals
yes, concurrent vehicle
Details on study design- Dose selection rationale: A preliminary study was conducted to determine the doses to be employed.
Male and female rats were receiving 0, 100, 300, and 1000 mg/kg bw/day (5 animals/sex/dose)of the substance was administered for 14 days. As the results, thickening in limiting ridge of thestomach was observed in 2 males and 2 females receiving 100 mg/kg bw/day. Thickening in limiting
ridge of the stomach and dilatation in the cecum were observed in almost all animals receiving 300
mg/kg bw/day or more. Decreases in body weights in males and food consumption in both sexes,
and increases in AST and ALT activities were observed in an early administration period at 1000 mg/
kg bw/day. Therefore, the high dose was set at 300 mg/kg/day, and the middle and low dose were set
at 60 and 12 mg/kg/day using common ratio 5.
11

Examinations
Observations and examinations performed and frequency
CAGE SIDE OBSERVATIONS: Yes- Time schedule:
Males and females: once a day before the start of administration, 3 times/day during the admini
stration period, and once a day during the recovery period
DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule:
Males: once before the start of administration, once a week during the administration and recovery
periods
Females: once before the start of administration, days 1, 7, 14 and 20 of gestation, and day 4 of lac
tationBODY WEIGHT: Yes- Time schedule for examinations:
Males in the main groups were weighed on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, 39 and 42 ofadministration and on the day of necropsy, and males and females in the recovery groups were
weighed on days 1, 4, 8, 11 and 14 of recovery and on the day of necropsy.
Females in the main groups were weighed on days 1, 4, 8, 11 and 15 of administration (uncopulated
animals were weighed on day 18 and 22 of administration as well), days 0, 4, 7, 11, 14, 17 and 20 of
gestation, days 0 and 4 of lactation and the day of necropsy.
FOOD CONSUMPTION : Yes
Measurement of food consumption was conducted on all animals at the following frequencies:
males in the main groups: on days 1, 4, 8, 11, 15, 32, 36, 39 and 42 of administration; males andfemales in the recovery groups on days 1, 4, 8, 11 and 14 of recovery in addition to the measureme
nt days for males in the main groups; and females in the main groups on days 1, 4, 8, 11 and 15 of administration, days 1, 4, 7, 11, 14, 17 and 20 of gestation and days 2 and 4 of lactation.
FOOD INTAKE: No
HAEMATOLOGY: Yes- Time schedule for collection of blood: On the next day of the last administration and on the last dayof the recovery period- Anaesthetic used for blood collection: Yes (identity)- Animals fasted: Yes- How many animals:5 animals/sex/group- Parameters examined: red blood cell count, hemoglobin, hematocrit, mean corpuscular volume,
mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, reticulocyte percentage, platelet count, white blood cell count, differential white blood cell count, absolute number of each
white blood cell, prothrombin time, activated partial thromboplastin time, fibrinogen volume
CLINICAL CHEMISTRY: Yes- Time schedule for collection of blood: On the next day of the last administration and on the last dayof the recovery period- Animals fasted: Yes- How many animals: 5 animals/sex/group- Parameters checked: ALP, total cholesterol, triglyceride, phospholipids, total bilirubin, glucose, bloodurea nitrogen, creatinine, sodium, potassium, chloride, calcium, inorganic phosphorus, total protein, albumin, A/G ratio, AST (GOT), ALT (GPT), LDH, γ-GTP
URINALYSIS: Yes- Time schedule for collection of urine (males): final week of administration period (days 37 to 38 ofadministration) and in the final week of recovery period (days 9 to 10 of recovery)- Metabolism cages used for collection of urine: Yes- Animals fasted: Yes
Collection of four-hour urine samples under fasting but ad libitum drinking conditions, followed bycollection of 20-hour urine samples under ad libitum feeding and drinking conditions.
- Parameters checked: pH, protein, ketones. glucose, occult blood, bilirubin, urobilinogen, color, sedim
ent, urine volume (4-hour sample), osmotic pressure, urine volume (20-hour sample), water intake (4hour+20-hour volume)
BLOOD HORMONE: No
12

- Time schedule for collection of serum: No- Parameters checked: No
NEUROBEHAVIOURAL EXAMINATION: Yes- Time schedule for examinations: Manipulative test and measurements of grip strength and motor activity were conducted on 5 animals per group with the following frequencies: males in the main grou
ps were examined in the final week of administration (day 36 of administration), females in the maingroups on day 4 of lactation (day 42 and 43 of administration) after necropsy of F1 pups, and males
and females in the recovery groups in the final week of administration (day 36 of administration) andin the final week of recovery (day 8 of recovery).
- Dose groups that were examined: All animals were examined for detailed clinical signs once before
the start of administration. Thereafter, males in the main groups were examined once weekly during
the administration period, whereas females were observed once weekly during the pre-mating admini
stration period and mating period as well as on designated days during the gestation and lactation p
eriods (days 1, 7, 14 and 20 of gestation, and day 4 of lactation). Animals in the recovery groups were
examined once weekly during the administration and recovery periods.
- Battery of functions tested:
1) Open field observation. Arousal, gait, posture, tremor, convulsion, rearing count, defecation (defeca
tion count, urination), stereotypy (grooming, circling, etc.), abnormal behavior (self-biting, backward
walking, etc.)
2) Manipulative Test. Auditory response, approach response, touch response, tail pinch response, pupi
llary reflex, aerial righting reflex, landing foot splay
3) Measurement of Grip Strength. Following manipulative test, grip strength of forelimb and hind limb
was measured by CPU gauge MODEL-9502A (AIKOH Engineering Co., Ltd.).
4) Measurement of Motor Activity.Following measurement of grip strength, motor activity wasmeasured by a motor activity sensor for experimental animals NS-AS01 (NeuroScience, Inc). The
measurement was conducted for 1 hour, and measured values at 10-minute intervals and from 0 to 6
0 minutes were recorded.
Sacrifice and pathology
GROSS PATHOLOGY AND ORGAN WEIGHTS：Yes
Brain, thyroids(including parathyroids), thymus, heart, liver, spleen, kidneys, adrenals, testes, andepididymis
HISTOPATHOLOGY: Yes
Cerebrum, cerebellum, pituitary, spinal cord (thoracic), thyroid, parathyroid, adrenal glands, thymus,
spleen, submandibular lymph nodes, mesenteric lymph nodes, heart, lung (including bronchial),
stomach, duodenum, jejunum, ileum, cecum, colon, rectum, liver, kidney, bladder, testis, epididymis,
ovary, uterus, seminal vesicles, sternum and femur (including bone marrows), macroscopic lesions, a
nd parts for identification (auricles)
Statistics
The data were analyzed for homogeneity of variance by the Bartlett test (level of significance: 0.01,
two-tailed). If variances were homogeneous, data were analyzed by the Dunnett test, whereas hetero
geneous data were analyzed by the Steel test. In the recovery test, these values of two groups wereanalyzed by F test and Student or Aspin-Welch t-test. Frequency data were analysed by Fisher test. S
tatistical significance was set at < 5% by two-sided

Results and discussion
Results of examinations
Clinical signs
effects observed, treatment-related
Mortality
mortality observed, treatment-related13

Body weight and weight changes
no effects observed
Food consumption and compound intake (if feeding study)no effects observed
Food efficiency
not examined
Haematological findings
effects observed, treatment-related
Clinical biochemistry findings
effects observed, treatment-related
Urinalysis findings
no effects observed
Behaviour (functional findings)
no effects observed
Organ weight findings including organ / body weight ratios
no effects observed
Gross pathological findings
effects observed, treatment-related
Histopathological findings: non-neoplastic
effects observed, treatment-related
Histopathological findings: neoplastic
not specified
Details on results
CLINICAL SIGNS AND MORTALITY: Mortality: No animal died in any group.Clinical signs: Salivation
was observed in six males (main group) receiving 300 mg/kg bw/day on week 4 of the dosing period.
This effect was considered to be due to irritating property of the test substance.
DETAILED CLINICAL OBSERVATIONS, MANIPULATIVE TEST, GRIP STRENGTH TEST AND
LOCOMOTOR ACTIVITY MEASUREMENT:
Home cage observation: No effects
In-the-hand observation: No effects
Open field observation: No effects
Manipulative test: A significant decrease in landing foot splay was observed in females receiving 300
mg/kg bw/day on Day 4 of the lactation period, but it was considered to be spontaneous.
Measurement of grip strength: No effects
Measurement of Motor Activity: No effects
BODY WEIGHT: No effects
FOOD CONSUMPTION: No effects
URINALYSIS: No effects
HAEMATOLOGY: Significant decreases in hemoglobin and hematocrit levels were observed infemales receiving 300 mg/kg bw/day at the end of the dosing period. Significant increases in hemogl
obin and hematocrit levels and a significant decrease in reticulocyte counts were observed in females
receiving 300 mg/kg bw/day at the end of the recovery period.
CLINICAL CHEMISTRY: A significant increase in ALT and a decrease in total protein level were obs
erved in males receiving 300 mg/kg bw/day at the end of the dosing period.
ORGAN WEIGHTS: There were no changes related to the test substance in any group during the dosi
ng and recovery periods.
GROSS PATHOLOGY:
At the End of the Administration Period
Cecum: Dilatation was observed in eight males and two females receiving 300 mg/kg bw/day.
14

Stomach: Thickening in limiting ridge was observed in four males and two females receiving 300 mg/
kg bw/day.
At the End of the Recovery Period
There were no lesions related to the test substance in any group.
HISTOPATHOLOGY: NON-NEOPLASTIC:At the End of the Administration Period
Both sexes had minimal hypertrophy of the duodenal mucosal epithelia at 300 mg/kg bw/day
Intestine: Diverticulum in ileum was observed in one control male.
Kidney: Cyst was observed in one control male.
Spleen: Focus in raised was observed in one control male.
At the End of the Recovery Period
There were no lesions related to the test substance in any group.

Effect levels
Key result
false
Dose descriptor
NOAEL
Effect level60

mg/kg bw/day (actual dose received)

Based onact. ingr.
Sexmale/female
Basis for effect level
other: Decreases in hemoglobin and hematocrit levels(females), increases in ALT (males), and lesi
ons in the caecum, stomach and duodenum at 300 mg/kg bw/day.

Target system / organ toxicity
Key result
false
Critical effects observed
not specified

Any other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF70974-33-3d.pdf

Applicant's summary and conclusion
15

Conclusions
Based on the changes in the blood and gastrointestinal organs, the NOAEL of repeated dose toxicity w
as determined to be 60 mg/kg bw/day in male and female rats.
Executive summary

A combined repeated oral dose toxicity study with the reproduction/developmental toxicity screening
test was performed according to the OECD TG 422. Male and female rats (12 animals/sex/dose) wereadministered benzenesulfonic acid, 4-hydroxy-, tin (2+) salt at 0, 12, 60, and 300 mg/kg bw/day. Males
were dosed for 42 days, including a 14-day pre-mating period and subsequent mating period. Females
were dosed for 41–51 days, including 14 day pre-mating, mating, and gestation periods, and the time
until lactation day 4. Five animals/sex/dose administered 0 and 300 mg/kg bw/day were treated as arecovery group and examined after a 14 day recovery period.
Salivation was observed after 4 weeks of administration in males at 300 mg/kg bw/day. Afterthe administration period, rats administered 300 mg/kg bw/day showed decreased hemoglobin andhematocrit levels in females and increased serum alanine transaminase levels in males. By grosspathology, both sexes exhibited thickening of the limiting ridge of the stomach and dilatation of thececum at 300 mg/kg bw/day. Upon histopathological examination, both sexes had minimal hypertrophyof the duodenal mucosal epithelia at 300 mg/kg bw/day. These changes resolved after the recovery
period. Based on the changes in the blood and gastrointestinal organs, the NOAEL of repeated dose
toxicity was determined to be 60 mg/kg bw/day in male and female rats.

16

Genetic toxicity
Genetic toxicity in vitro
ENDPOINT_STUDY_RECORD: Genetic toxicity in vitro.001

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Administrative data
Endpoint
in vitro gene mutation study in bacteria Type of genotoxicity: gene mutation
Type of information
experimental study
Adequacy of study
other information
Robust study summary
false
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
other: OECD Test Guideline study under GLP condition

Data source
Reference
Reverse Mutation Test of Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt on Bacteria. / MHLW, Japan /study report
Data accessdata published

Materials and methods
Test guideline
Qualifieraccording to guideline17

Guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
in vitro gene mutation study in bacteria
Deviations
no
Qualifieraccording to guideline
Guideline
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
GLP compliance
yesType of assay
bacterial reverse mutation assay
in vitro gene mutation study in bacteria

Test material
Test material information
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt
Specific details on test material used for the study- Name of test material (as cited in study report): Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt- Chemical structure: [C6H4(OH)SO3]2Sn- Chemical formula: C12H10O8S2Sn- Molecular weight: 465.05- Puitality: >95%
- Impurities: Benzenesulfonic acid, 2-hydroxy-, tin(2+)salt; <2% ; Benzenesulfonic acid, 2,4-hydroxy-, tin(2+)salt; <2%- Solubility: 420 mg/mL in water- Supplier: Daiwakasei Industry Co., Ltd- Physical state: White crystalline solid- Stability: Stability during the test period was confirmed by the Daiwakasei Industry Co., Ltd (May 19,2006).
- Storage condition of test material: Room temperature

MethodSpecies / strain
Species / strain / cell typeother: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and Escherichia coli WP2 uvrA
Metabolic activation
with and without
Metabolic activation system
S9 mix; rat liver, induced by phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose
-S9 mix: 156, 313, 625, 1250, 2500, 5000 μg/plate (TA100, TA1535, TA98, TA1537, WP2uvrA strains)+S9 mix: 156, 313, 625, 1250, 2500, 5000 μg/plate (TA100, TA1535, TA98, TA1537, WP2uvrA strains)18

Vehicle / solvent- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controlsnoNegative solvent / vehicle controls
yes
True negative controlsnoPositive controls
yes
Positive control substanceother:
Remarks
S9 mix: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide (TA 100, TA98 and WP2 uvrA), sodium azide(TA1535) and 9-aminoacridine hydrochloride (TA1537). +S9 mix: 2-aminoanthracene (all strains)
Details on test system and experimental conditions
METHOD OF APPLICATION: Preincubation
DURATION- Preincubation period: 20 min at 37 °C - Exposure duration:48 hrs
NUMBER OF PLATES: 3
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY- growth inhibition
Evaluation criteria
When the mean number of revertant colonies per plate increased twice more than that of the negative
control and when a dose-related and reproducible increase was observed, the chemical was judged to
be mutagenic.
Statistics
No

Results and discussion
Test results
Key result
false
Species / strainother: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and Escherichia coli WP2 uvrA
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity
19

Vehicle controls validity
valid
Positive controls validity
valid
Additional information on results
RANGE-FINDING/SCREENING STUDIES:Concentration: 8.19, 20.5, 51.2, 128, 320, 800, 2000, 5000 μg/
plate
Cytotoxic conc.: Yes TA1537 at 5000 ug/plate with S9 mix.
Remarks on result
other: all strains/cell types tested Migrated from field 'Test system'.

Any other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF70974-33-3e.pdf

Applicant's summary and conclusion
Conclusions
Interpretation of results (migrated information):negative with and without S9mix
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt did not induce gene mutations in the in vitro bacteria
test.

20

ENDPOINT_STUDY_RECORD: Genetic toxicity in vitro.002

UUID: IUC5-680c7bae-5540-4e98-8666-ad76fea19cfc
Dossier UUID:
Author:Date: 2022-12-12T15:29:58.178+09:00
Remarks:

Administrative data
Endpoint
in vitro cytogenicity / chromosome aberration study in mammalian cells Type of genotoxicity: genemutation
Type of information
experimental study
Adequacy of study
other information
Robust study summary
false
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
other: OECD Test Guideline study under GLP condition

Data source
Reference
In Vitro Chromosomal Aberration Test of Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt on Cultured Ch /MHLW, Japan / study report
Data accessdata published

Materials and methods
Test guideline
Qualifieraccording to guideline
Guideline
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)in vitro cytogenicity / chromosome aberration study in mammalian cells
21

Deviations
no
Qualifieraccording to guideline
Guideline
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviationsno
GLP compliance
yesType of assay
in vitro mammalian chromosome aberration test
chromosome aberration

Test material
Test material information
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt
Specific details on test material used for the study- Name of test material (as cited in study report): Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt- Chemical structure: [C6H4(OH)SO3]2Sn- Chemical formula: C12H10O8S2Sn- Molecular weight: 465.05- Puitality: >95%
- Impurities: Benzenesulfonic acid, 2-hydroxy-, tin(2+)salt; <2% ; Benzenesulfonic acid, 2,4-hydroxy-, tin(2+)salt; <2%- Solubility: 420 mg/mL in water- Supplier: Daiwakasei Industry Co., Ltd- Physical state: White crystalline solid- Stability: Stability during the test period was confirmed by the Daiwakasei Industry Co., Ltd (May 19,2006).
- Storage condition of test material: Room temperature

MethodSpecies / strain
Species / strain / cell typemammalian cell line, other: Chinese hamster lung(CHL/IU) cells
mammalian cell line
Metabolic activation
with and without
Metabolic activation system
S9 mix; rat liver, induced by phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose
-S9 mix (continuous treatment): 0, 181, 259, 370, 528, 755, 1078 ug/mL-S9 mix (short-term treatment): 0, 370, 528, 755, 1078, 1540 ug/mL+S9 mix (short-term treatment): 0, 370, 528, 755, 1078, 1540, 2200 ug/mL

22

Vehicle / solvent- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controlsnoNegative solvent / vehicle controls
yes
True negative controlsnoPositive controls
yes
Positive control substanceother:
Remarks[continuous treatment and short time treatment, -S9]: mitomycin C; [short-term treatment, +S9]: cycl
ophsophamide
Details on test system and experimental conditions
METHOD OF APPLICATION: Exposure duration: [continuous treatment]: 24 hrs [short-term treatment]:6 hrs + 18 hr
SPINDLE INHIBITOR: Colcemid
STAIN: Giemsa stain for 12 min.
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 200 cells / dose
DETERMINATION OF CYTOTOXICITY- Method: relative total growth
RANGE-FINDING/SCREENING STUDIES:
1st test; Concentration: 9.08, 18.2, 36.3, 72.7, 145, 291, 581, 1163, 2325, and 4650 μg/mL (10 mM)
Visible precipitation was observed at 1163 ug/mL and higher
2nd test to confirm cytotoxicity; Concentration: 581, 1163, 2325, and 4650 ug/mL (10 mM)
50% growth inhibitions were observed at 1086 ug/mL for -S9, 1796 ug/mL for +S9, 510 ug/mL for con
tentious treatment
Evaluation criteria
For the evaluation of the frequencies of structural aberrations and of polyploidy induced, the following
criteria, which are usually used for chromosomal aberration testing with CHL, were employed.App
earance incidence of cell with chromosomal aberrations:Negative(-): less than 5%Equivocal(±): 5% or
more, less than 10%Positive(+): 10% or more
Statistics
Fisher and Chochran-Armitage trend tests (one-sided test, P = 2.5%)

Results and discussion
Test results
Key result
false
Species / strain
mammalian cell line, other: Chinese hamster lung (CHL/IU) cells
mammalian cell line
23

Metabolic activation
with and without
Genotoxicity
positive
Cytotoxicity / choice of top concentrations
cytotoxicity
Vehicle controls validity
valid
Positive controls validity
validRemarks on result
other: all strains/cell types tested Migrated from field 'Test system'.

Any other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF70974-33-3f.pdf

Applicant's summary and conclusion
Conclusions
Interpretation of results (migrated information):
positive
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt induce chromosomal aberrations in cultured cells withand without S9 mix under the conditions of this study. The positive control showed expected results.

24

Toxicity to reproduction
Toxicity to reproduction
ENDPOINT_STUDY_RECORD: Toxicity to reproduction.001

UUID: IUC5-c6d5ef64-4719-4fbb-8394-78905f3abbe7
Dossier UUID:
Author:Date: 2022-12-16T16:07:45.474+09:00
Remarks:

Administrative data
Endpoint
screening for reproductive / developmental toxicity based on test type (migrated information)
Type of information
experimental study
Adequacy of study
other information
Robust study summary
false
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
other: OECD Test Guideline study under GLP condition
Cross-reference
Reason / purpose for cross-reference
reference to same study
Remarks
7.5.Repeated dose toxicity: oral: Repeated dose toxicity: oral.001

Data source
Reference
A combined repeated-dose/reproductive-developmental toxicity study of Benzenesulfonic acid, 4hydrox / MHLW, Japan / study report
Data accessdata published25

Materials and methods
Test guideline
Qualifieraccording to guideline
Guideline
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction /Developmental Toxicity Screening Test)
Deviationsno
GLP compliance
yes
Limit test
no

Test material
Test material information
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt
Specific details on test material used for the study- Name of test material (as cited in study report): Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt- Lot No.: 060501- Supplier: Daiwakasei Industry Co., Ltd- Chemical structure: [C6H4(OH)SO3]2Sn- Chemical formula: C12H10O8S2Sn- Molecular weight: 465.05- Puitality: 96.0%- Impurities: Benzenesulfonic acid, 2-hydroxy-, tin(2+)salt; <2% ; Benzenesulfonic acid, 2,4-hydroxy-, tin(2+)salt; <2%- Boiling point: 300°C or more
- Solubility: White turbidity in 2% ethanol- Storage condition of test material: Cold dark place at 2 - 8°C

Test animals
Speciesrat
Strain
Crj: CD(SD)rat
Sexmale/female
Details on test animals or test system and environmental conditions
TEST ANIMALS- Source: Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation:10 weeks of age- Weight at study initiation: 340-409 g for males and 205-257 g for females- Housing: bracket-type metallic wire-mesh cages (W 250 × D 350 × H 200 mm)- Diet (e.g. ad libitum):ad libitum26

- Water (e.g. ad libitum):ad libitum- Acclimation period:15 days
ENVIRONMENTAL CONDITIONS- Temperature (°C):21 to 26°C
- Humidity (%): 38 to 63%- Air changes (per hr):10 to 15 times per hour
- Photoperiod (hrs dark / hrs light):12-hour lighting per day

Administration / exposure
Route of administration
oral: gavage
Vehiclewater
Details on exposure
PREPARATION OF DOSING SOLUTIONS: Test substance was dissolved in distilled water for injection.
VEHICLE- Justification for use and choice of vehicle: No data
- Amount of vehicle (if gavage): 5 ml/kg bw- Lot/batch no. (if required): No data
- Dosing volume: 5 mL/kg- Storage condition of test solution: Stored in a refrigerator
Analytical verification of doses or concentrations
yes
Details on analytical verification of doses or concentrations
Test suspensions at each concentration to be used for males in week 1 and 6 of administration wereanalyzed by the HPLC method at Bozo Research Center Inc. Results showed that the concentration of
the test article in each suspension was 94.5 to 107.5% of the nominal concentration, and both values
were within the acceptable range (concentration: percentage of the nominal concentration, 100 ±10%; C.V.: 10% or below)
Duration of treatment / exposure
All males and females without mating: 42 days
Females with mating: up to 51 days including 14 days pre-mating, mating and gestation periods anduntil day 4 of lactation
Frequency of treatment
Daily: 7 times / week
Doses / concentrations
Remarks
Doses / Concentrations:
0 (vehicle), 12, 60 and 300 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose
12 animals/sex/dose with mating (main dose group), 5 animals/sex/dose at 0 and 300 mg/kg bw/day
without mating (recovery group)27

Control animals
yes, concurrent vehicle
Details on study design- Dose selection rationale: A preliminary study was conducted to determine the doses to be employed.
Male and female rats were receiving 0, 100, 300, and 1000 mg/kg bw/day (5 animals/sex/dose)of the substance was administered for 14 days. As the results, thickening in limiting ridge of thestomach was observed in 2 males and 2 females receiving 100 mg/kg bw/day. Thickening in limiting
ridge of the stomach and dilatation in the cecum were observed in almost all animals receiving 300
mg/kg bw/day or more. Decreases in body weights in males and food consumption in both sexes,
and increases in AST and ALT activities were observed in an early administration period at 1000 mg/
kg bw/day. Therefore, the high dose was set at 300 mg/kg/day, and the middle and low dose were set
at 60 and 12 mg/kg/day using common ratio 5.

Examinations
Parental animals: Observations and examinations
See 7.5.1 Repeated dose toxicity: oral Endpoint study record: Repeated dose toxicity: oral.001 for observations and examinations for general toxicity
Oestrous cyclicity (parental animals)
Vaginal smears were collected from all females in the main groups and microscopically examined
every day from the day after the start of administration until the day copulation was confirmed.
During the pre-mating administration period, vaginal smear pictures were classified as proestrus,
estrus, metestrus or diestrus and examined for the frequency of estrus and interval between estruses(estrous cycle). During the mating period, vaginal smears were examined for the presence of sperm.
Sperm parameters (parental animals)
Parameters examined in P male parental generations: testes weight, epididymides weight
Litter observations
PARAMETERS EXAMINED: Number and sex of pups, stillbirths, live births, postnatal mortality,
presence of gross anomalies, and weight gain.
GROSS EXAMINATION OF DEAD PUPS: Yes, for external and internal abnormalities.
Postmortem examinations (parental animals)
SACRIFICE: Male animals: Rats were euthanized by exsanguination under ether anesthesia on the day
after the last administration. Maternal animals: Rats were euthanized by exsanguination under ether
anesthesia on day 4 of lactation.
GROSS PATHOLOGY AND ORGAN WEIGHTS：Yes
Brain, thyroids(including parathyroids), thymus, heart, liver, spleen, kidneys, adrenals, testes, andepididymis
HISTOPATHOLOGY: Yes
Cerebrum, cerebellum, pituitary, spinal cord (thoracic), thyroid, parathyroid, adrenal glands, thymus, sp
leen, submandibular lymph nodes, mesenteric lymph nodes, heart, lung (including bronchial), stomach,
duodenum, jejunum, ileum, cecum, colon, rectum, liver, kidney, bladder, testis, epididymis, ovary,uterus, seminal vesicles, sternum and femur (including bone marrows), macroscopic lesions, andparts for identification (auricles)
Postmortem examinations (offspring)
SACRIFICE: The F1 pups were euthanized on PND 4 by exsanguination under ether anesthesia.
GROSS NECROPSY: Yes
Statistics
The data were analyzed for homogeneity of variance by the Bartlett test (level of significance: 0.01,
two-tailed). If variances were homogeneous, data was analyzed by the Dunnett test, whereas heterog
eneous data was analyzed by a Steel test. In the recovery test, these values of two groups were anal
28

yzed by F test and Student or Aspin-Welch t-test. Frequency data were analysed by Fisher test. Stati
stical significance was set at < 5% by two-sided
Reproductive indices
Each parameter was determined by the following equations:
Copulation index (%) = (No. of copulated animals/No. of co-housed animals) × 100
Fertility index (%) = (No. of pregnant females/No. of copulated females) × 100
Insemination index (%) = (No. of pregnant females/No. of copulated males) × 100
Duration of gestation (days) = day 0 of lactation – day 0 of gestation
Delivery index (%) = (No. of females delivered liveborn pups/No. of pregnant females) × 100
Implantation index (%) = (No. of implantation sites/No. of corpora lutea) × 100
Stillborn index (%) = (No. of stillborn pups/Total No. of pups born) × 100
Liveborn index (%) = (No. of liveborn pups/Total No. of pups born) × 100
External abnormalities (%) = (No. of pups with external abnormalities/No. of liveborn pups) × 100
Sex ratio = No. of males/(No. of males + No. of females)
Viability index (%) = (No. of surviving pus on day 4 after birth/No. of liveborn pups on day 0 after birth)
× 100
Offspring viability indices
Number of live pups on day 0 of lactationBirth index (%) = (Number of live pups on day 0/Number of i
mplantation sites) ×100
Live birth index (%) = (Number of live pups on day 0/Number of pups born) ×100
Pups weight on day 0 of lactationSex ratio on day 0 of lactation
Number of live pups on day 4 of lactation
Pups weight on day 4 of lactation
Sex ratio on day 4 of lactation
Viability index = (Number of live pups on day 4 after birth/Number of live pups born) ×100

Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
Clinical signs
effects observed, treatment-related
Body weight and weight changes
effects observed, treatment-related
Food consumption and compound intake (if feeding study)
effects observed, treatment-related
Organ weight findings including organ / body weight ratios
no effects observed
Description (incidence and severity)
on reproductive organ
Gross pathological findings
no effects observed
Description (incidence and severity)
on reproductive organ
Histopathological findings: non-neoplastic
no effects observed29Description (incidence and severity)
on reproductive organs
Other effects
not examined

Reproductive function / performance (P0)
Reproductive function: oestrous cycle
no effects observed
Reproductive performanceno effects observed

Details on results (P0)1) Estrous Cycle
There were no animals showing abnormal estrous cycles, and there were no significant differences in
the average length of the estrous cycle between the control group and any treatment group.
2) Results of Mating
There were no significant differences in the number of elapsed days until copulation, copulation index,
insemination index or fertility index between the control group and any treatment groups.
3) Delivery Data and Delivery
There were no significant differences in the delivery index, duration of gestation, number of corpora
lutea, number of implantation sites, implantation index, stillborn index, number of liveborn pups or liv
eborn index between the control group and any treatment groups.No changes in nesting, gather thepups, and breast-feeding behavior were observed in all dams during the lactation period.

Effect levels (P0)
Key result
false
Dose descriptor
NOAEL
Effect level300

mg/kg bw/day (actual dose received)

Based onact. ingr.
Sexmale/female
Basis for effect level
other: Noeffects on reproduction

Results: F1 generation
General toxicity (F1)Clinical signs
no effects observed30Mortality / viability
no mortality observed
Body weight and weight changes
no effects observed
Gross pathological findings
no effects observed

Effect levels (F1)
Key result
false
Dose descriptor
NOAEL
Generation
F1
Effect level300

mg/kg bw/day (actual dose received)

Based onact. ingr.
Sexmale/female
Basis for effect level
other: No effects on development

Overall reproductive toxicity
Key result
false
Reproductive effects observed
not specified

Any other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF70974-33-3d.pdf

Applicant's summary and conclusion
Executive summary
In the combined repeated oral dose toxicity study with the reproduction/developmental toxicity
screening test (OECD TG 422), there were no effects on reproductive and developmental parameters31

at 300 mg/kg bw/day. The NOAEL for the rat reproductive/developmental toxicity of benzenesulfonicacid, 4-hydroxy-, tin(2+) salt was determined to be 300 mg/kg bw/day, the highest dose tested.

32

References
Reference Substances
REFERENCE_SUBSTANCE: 70974-33-3
UUID: d2f7327d-0f8a-3ab2-a827-e4339ea06bf6
Dossier UUID:
Author:Date: 2017-01-18T15:00:11.000+09:00
Remarks:
Reference substance name70974-33-3
IUPAC name70974-33-3

Inventory
CAS number
70974-33-3

33

REFERENCE_SUBSTANCE: Benzenesulfonic acid, 4hydroxy-, tin(2+) salt
UUID: 98ffb958-bfec-47e8-94da-2934cfb3e897
Dossier UUID:
Author:Date: 2019-09-03T16:38:07.000+09:00
Remarks:
Reference substance nameBenzenesulfonic acid, 4-hydroxy-, tin(2+) salt

Inventory
CAS number
70974-33-3

34

Test Materials
TEST_MATERIAL_INFORMATION: Benzenesulfonic acid,
4-hydroxy-, tin(2+)salt
UUID: 4fe9d66e-438c-3ab2-b743-a623fc4ee0a9
Dossier UUID:
Author:Date: 2022-12-12T15:23:43.580+09:00
Remarks:
Name
Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt

Composition
Composition
Type
Constituent
Reference substance
70974-33-3 / 70974-33-3 / 70974-33-3
EC number

EC name

CAS number

CAS name

70974-33-3
IUPAC name70974-33-3

35

Literatures
LITERATURE: A combined repeated-dose/reproductivedevelopmental toxicity study of Benzenesulfonic acid, 4hydroxy-, tin(2+)salt by oral administration in rats.
UUID: e04fcd9b-5edc-34b4-95e1-a71c4e81b070
Dossier UUID:
Author:Date: 2017-01-18T15:46:34.000+09:00
Remarks:

General information
Reference Typestudy report
Title
A combined repeated-dose/reproductive-developmental toxicity study of Benzenesulfonic acid, 4hydroxy-, tin(2+)salt by oral administration in rats.
Author
MHLW, Japan
Year
2009
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
BoZo Research Center Inc
Report date2009-04-10
Report number
R-945

36

LITERATURE: In Vitro Chromosomal Aberration Test ofBenzenesulfonic acid, 4-hydroxy-, tin(2+)salt on Cultured
Chinese Hamster Cells.
UUID: 8d0fc545-3aee-3f58-b439-4febb72e2944
Dossier UUID:
Author:Date: 2017-01-18T17:06:07.000+09:00
Remarks:

General information
Reference Typestudy report
Title
In Vitro Chromosomal Aberration Test of Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt on Cultured Ch
inese Hamster Cells.
Author
MHLW, Japan
Year
2006
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Biosafety Research Center, Foods, Drugs and Pesticides (Anpyo Center)
Report date
2006-09-19
Report number
9053 (115-204)

37

LITERATURE: Reverse Mutation Test of Benzenesulfonicacid, 4-hydroxy-, tin(2+)salt on Bacteria.
UUID: 7c3c1ace-5565-39db-9bf7-705153fd0090
Dossier UUID:
Author:Date: 2017-01-18T16:47:14.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Reverse Mutation Test of Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt on Bacteria.
Author
MHLW, Japan
Year
2006
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Biosafety Research Center, Foods, Drugs and Pesticides (Anpyo Center)
Report date
2006-09-19
Report number
9052 (115-203)

38

LITERATURE: Single Dose Oral Toxicity Test ofBenzenesulfonic acid, 4-hydroxy-, tin(2+)salt in RatsUUID: a2820de3-8cd5-3360-b920-e24bbb2bf4a4
Dossier UUID:
Author:Date: 2017-01-18T15:00:11.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Single Dose Oral Toxicity Test of Benzenesulfonic acid, 4-hydroxy-, tin(2+)salt in Rats
Author
MHLW, Japan
Year
2007
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Biosafety Research Center, Foods, Drugs and Pesticides (An-Pyo Center)
Report date
2007-01-26
Report number
9079 (115-206)

39

Legal Entities
LEGAL_ENTITY: National Institute of Health Sciences
UUID: IUC4-b036ff75-0f3c-323b-b200-ed5f46cf5101
Dossier UUID:
Author:Date: 2022-11-07T15:49:29.000+09:00
Remarks:

General information
Legal entity nameNational Institute of Health Sciences
Remarks
Disclaimer: The contents in this document were created based on the MHLW (Ministry of Health,Labour and Welfare) peer reviewed study reports (in Japanese) in JECDB (Japan Existing Chemical
Database) at http://dra4.nihs.go.jp/mhlw_data/jsp/SearchPageENG.jsp. Authorship is in the Divisionof Risk Assessment, the National Institute of Health Sciences, and the contents do not reflect any official MHLW opinions or any other regulatory policies.

Address
Address 1
Tonomachi 3-25-26
Address 2
Kawasaki-ku
Postal code
210-9501
Town
KawasakiRegion / State
Kanagawa
CountryJapan
JP

Identifiers
Other IT system identifiers
IT system
LEO
ID
10767
IT systemIUCLID440

ID16558402024DIV750

41