Name: COMPLETE / SUBSTANCE : 2-Chlorobenzoyl chloride / 2-chlorobenzoyl chloride /609-65-4 Fri, 16 Dec 2022, 14:20:21+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
2-Chlorobenzoyl chloride ...................................................................................... 3
CORE .......................................................................................................... 3
1 General information .......................................................................... 3
1.10 Assessment approach (assessment entities) ......................... 3
Assessment approach (assessment entities) ........................ 3
OECD .......................................................................................................... 4
D Health Effects .................................................................................. 4
60 Acute toxicity: oral .................................................................. 4
Acute toxicity: oral.001 ........................................................ 4
67 Repeated dose toxicity: oral .................................................... 8
Repeated dose toxicity: oral.001 ........................................... 870 Genetic toxicity in vitro ......................................................... 16
Genetic toxicity in vitro.001 ................................................ 16
Genetic toxicity in vitro.002 ................................................ 21
73 Toxicity to reproduction ........................................................ 25
Toxicity to reproduction.001 ............................................... 25
DOMAIN .................................................................................................... 35
Substance ......................................................................................... 35
Substance ................................................................................ 35
References ................................................................................................................ 36
Reference Substances ...................................................................................... 36
2-chlorobenzoyl chloride ............................................................................ 36
Test Materials .................................................................................................. 38
2-Chlorobenzoyl chloride ............................................................................ 38
Literatures ....................................................................................................... 39
A combined repeated dose/reproductive developmental toxicity study of 2chlorobenzoyl chloride by oral administration in rats. ................................... 39
In Vitro Chromosomal Aberration Test of 2-Chlorobenzoyl chloride on
Cultured Chinese Hamster Cells ................................................................. 40
Reverse Mutation Test of 2-Chlorobenzoyl chloride ..................................... 41
Single Dose Oral Toxicity Test of 2-Chlorobenzoyl chloride ........................... 42
Legal Entities ................................................................................................... 43
National Institute of Health Sciences .......................................................... 43ii

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2-Chlorobenzoyl chloride / 2-chlorobenzoyl chloride / 609-65-4
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LEGAL_ENTITY: National Institute of Health
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General information
Legal entity nameNational Institute of Health Science22-Chlorobenzoyl chloride
CORE
General information
Assessment approach (assessment entities)
FIXED_RECORD: Assessment approach

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OECD
Health Effects
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
key study
Robust study summary
true
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
guideline study
Reliability 1

Data source
Reference
Single Dose Oral Toxicity Test of 2-Chlorobenzoyl chloride / MHLW (Ministry of Health, Labour andWelfare), Japan / study report
Data accessdata published

Materials and methods
4Test guideline
Qualifieraccording to guideline
Guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance
yes
Test type
acute toxic class method
Limit test
yes

Test material
Test material information
2-Chlorobenzoyl chloride
Specific details on test material used for the study- Name of test material (as cited in study report): 2-chlorobenzoyl chloride- Lot No.: GK01 (Tokyo Chemical Industry Co., Ltd.)- Purity: 99.2%- Solubility: soluble in corn oil- Physical state: Colorless liquid- Storage condition of test material: in cool (2-10 degree C) and dark place

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 or 8 weeks old- Weight at dosing: 184-204 g– Used animal number: A total of 12 females (3 animals/step)- Housing: one animal/cage- Diet (e.g. ad libitum): Ad libitum- Water (e.g. ad libitum): Ad libitum- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS- Temperature (°C): 22±3°C（21-24 °C）- Humidity (%): 50±20%（47-69%）- Ventilation (per hr): 10-15 times5- Photoperiod (hrs light / hrs dark): 12/12

Administration / exposure
Route of administration
oral: gavage
Vehiclecorn oil
Details on oral exposure
MAXIMUM DOSE VOLUME APPLIED:5 ml/kg b.w.
Doses
2000 mg/kg bw (1st and 2nd steps)
No. of animals per sex per dose
3 females/doseControl animals
noDetails on study design- Duration of observation period following administration: 14 days
- Frequency of observations: for one hour after dosing, and 2 and 4h after dosing (1st step). For one h
our after dosing, and 2, 4, and 6h after dosing (2nd step). Thereafter, twice a day on Days 2 to 13, andonce a day on Day 14.
- Frequency of weighing: One day before dosing, before administration, and on Days 1, 3, 5, 7, 10 and 1
4.
- Necropsy of survivors performed: Yes
Statistics
not used

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

mg/kg bw

Based onact. ingr.
Mortality
No deaths were observed in the first and second dosing groups.
6

Clinical signs
other: Diarrhea, mucous feces, soil of perianal fur and soil of perigenital fur were observed spo
radically.
Gross pathology
There were no changes related to the test substance.

Applicant's summary and conclusion
Conclusions
The acute oral LD50 of 2-Chlorobenzoyl chloride was >2000 mg/kg bw in female rats based on the
study conducted according to the OECD TG 423.

7

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

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Administrative data
Endpoint
repeated dose toxicity: oral, otherType of information
experimental study
Adequacy of study
key study
Robust study summary
false
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
guideline study
Reliability 1
Cross-reference
Reason / purpose for cross-reference
reference to same study
Related information
OECD / Toxicity to reproduction / Toxicity to reproduction.001 / 2-Chlorobenzoyl chloride / 2chlorobenzoyl chloride / 609-65-4

Data source
Reference
A combined repeated dose/reproductive developmental toxicity study of 2-chlorobenzoyl chloride byor / Ministry of Health, Labor and Welfare, Japan / study report
Data accessdata published

Materials and methods
8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
2-Chlorobenzoyl chloride
Specific details on test material used for the study- Name of test material (as cited in study report): 2-chlorobenzoyl chloride- Analytical purity: 99.2%- Storage condition of test material: at a cold (temperature 2-10°C) and dark place, with airtight stopper.
- Stability under test conditions: The stability of test material was identified by analysis of the remainder.

Test animals
Speciesratcommon rodent species
Strainother: Crl:CD(SD)Sexmale/female
Details on test animals or test system and environmental conditions
TEST ANIMALS- Source: Charles River Japan, Inc., Atsugi Breeding Center.
- Age at study initiation: 10 weeks old- Weight at study initiation: Male: 398.6 g (366 -432 g), Female: 257.2 g (235-283 g)- Housing: Animals were housed individually, except for during the acclimation (one or two animals
by sex), mating (one male and one female) and lactation periods (one litter), in metallic bracket-type
cages with wire mesh floors (300Wx 410D x 200H mm). From gestation day 17 to lactation day 4, individual dams and litters were reared on bedding.
- Diet: Solid feed (CRF-1: Oriental Yeast Co., ltd.) was given ad libitum.
- Water: Tap water was given ad libitum.
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
9

- Temperature (°C): 22±3 (actual temperature: 21-25°C)- Humidity (%): 50±20% (actual humidity: 44-69%)- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light (light: 8:00~20:00)

Administration / exposure
Route of administration
oral: gavage
Vehiclecorn oil
Details on oral exposure- Amount of vehicle (if gavage): 5 mL/kg- Dosing volume: 5 mL/kg
Analytical verification of doses or concentrations
yes
Duration of treatment / exposure(P) Males: 42 days including 14 days pre-mating(P)Females: 42-49 days including 14 days pre-mating, mating and gestation periods and the days until
day 4 of lactation
Female (no mating, satellite group): 42 days
Frequency of treatment
Once/day, 7 days/week
Doses / concentrations
Dose / conc.
0mg/kg bw/day (actual dose received)

Dose / conc.
40

mg/kg bw/day (actual dose received)

Dose / conc.
200

mg/kg bw/day (actual dose received)

Dose / conc.
1000

mg/kg bw/day (actual dose received)

No. of animals per sex per dose
Main group:12 animals/sex/dose
Satellite (Recovery) group: 5 males/dose and 5 females/dose (0 and 1000 mg/kg bw/day)10

Control animals
yes, concurrent vehicle
Details on study design- Dose selection rationale: Based on the results of a 14-day preliminary study, the highest dose of1000 mg/kg bw/day was selected as an expected obvious toxic dose, and the lowest dose of 40 mg/
kg bw/day was selected as an expected no toxic dose. The middle dose levels of 200 mg/kg bw/day
were selected.
- Rationale for animal assignment (if not random): Body weight-balanced randomization[14-day preliminary study]
A 14-day repeated dose oral toxicity test (Crl:CD(SD) rats, doses: 0 (olive oil), 30, 100, 300 or 1000 mg/
kg bw/day). Thickening of the forestomach mucosa was observed at 300 mg/kg bw/day or more.
At 1000 mg/kg bw/day, decrease in body weight and body weight gain, decrease in food consumpt
ion, decrease in urine pH were observed in males, low value of red blood cell count and hemoglobin
level were observed in females, high value of triglyceride, increase in liver and kidney weights wereobserved in both sexes.

Examinations
Observations and examinations performed and frequency
CAGE SIDE OBSERVATIONS: Yes- Time schedule: 2 times/day (am: before and after administration; pm) during the administration
period. 2 times/day (am and pm) during the recovery period.
DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule: Once before the start of administration, and once every week by the end of the study
period.
BODY WEIGHT: Yes- Time schedule for examinations:
Males were weighed on Day 1, 3, 5, 7, 10, 14, 21, 28, 35, and 42 of administration, and weighed on Day
7 and 14 of recovery.
Female satellite groups were weighted same frequencies to male recovery groups.
Females in the main groups were weighed on Day 1, 3, 5, 7, 10 and 14 of administration andcopulated females were weighed on Day 0, 1, 3, 5, 7, 14, 17 and 20 of gestation, and days 0, 1, and 4 oflactation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption: Yes
Measurement of food consumption was conducted on all animals at the following frequencies:
Males in the main and recovery groups; on Day 1, 3, 5, 7, 10, 14, 21, 28, 35, and 42 of administration,and on Day 7 and 14 of recovery.
Female satellite groups were weighted same frequencies to male recovery groups.
Females in the main group; on Day 1, 3, 5, 7, 10, and 14 of administration and copulated females were
weighed on Day 1, 3, 5, 7, 10, 14, 17 and 20 of gestation, and days 1 and 4 of lactation.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes- Time schedule for collection of blood: At the end of administration period, or at the end of recovery
period in both sexes- Anaesthetic used for blood collection: ether- Animals fasted: Yes
11

- How many animals: 5 animals/sex/group- Parameters examined included RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet, reticulocyte, PT, APTT, WBC and differential WBC.
CLINICAL CHEMISTRY: Yes- Time schedule for collection of blood: At the end of administration period, or at the end of recovery
period in both sexes- Animals fasted: Yes- How many animals: 5 animals/sex/group- Parameters examined included total protein, protein fraction, albumin, A/G ratio, total bilirubin,
glucose, total cholesterol, triglyceride, AST, ALT, ALP, gamma-GTP, BUN, creatinine, Na, K, Cl, Ca andIP.
URINALYSIS OF MALES: Yes- Time schedule for collection of urine (male only): On Week 6 (Day 40-41) of administration, and on
Week 2 (Day 12-13) of recovery.
- Metabolism cages used for collection of urine: Yes- How many animals: 5 animals/group- Parameters examined included color, urine volume, specific gravity, pH, protein, glucose, ketone
body, bilirubin, occult blood and urobilinogen.
NEUROBEHAVIOURAL EXAMINATION: Yes- Time schedule for examinations: On week 6 of the administration period, and on week 2 of therecovery period- Dose groups that were examined: All dose groups (5 animals/sex/group)- Battery of functions tested: sensory activity (hearing reaction, eye sight reaction, sense of touch
reaction, pain reaction, proprioceptive, righting reflex), grip strength, motor activity
Sacrifice and pathology
GROSS PATHOLOGY: Yes
ORGAN WEIBHT: Yes [brain, thymus, heart, liver, kidney, adrenal gland, spleen, testis, epididymis]
HISTOPATHOLOGY: Yes, [brain, pituitary, spinal cord, thyroid, parathyroid, heart, thymus, trachea,
lung, liver, kidney, adrenal, spleen, esophagus, stomach, pancreas, duodenum, jejunum, ileum, cecum,colon, rectum, eyeball and Harderian gland, sciatic nerve, bone, bone marrow, lymph nodes (mesente
ric and mandibular lymph nodes), urinary bladder, testis, seminal vesicle, prostate, epididymis, mammary gland, ovary and uterus.]
Statistics
The data were analyzed for homogeneity of variance by the Bartlett test. If variances were
homogeneous, data was analyzed by one-way ANOVA and the Dunnett test, whereas heterogeneous
data was analyzed by Kruskal-Wallis test and the Mann-Whitney U test.
For findings two or more grades was observed, data was analyzed by Kruskal-Wallis test and the Ma
nn-Whitney U test. For findings one grade was observed, data was analyzed by a multi-sample chisquare test and a two-sample chi-square test. For the comparison tests with the control group, thesignificance level was 5%.

Results and discussion
Results of examinations
Clinical signs
effects observed, treatment-related
12Mortality
mortality observed, treatment-related
Body weight and weight changes
effects observed, treatment-related
Food consumption and compound intake (if feeding study)
effects observed, treatment-related
Food efficiency
not examined
Water consumption and compound intake (if drinking water study)
not examined
Ophthalmological findings
not examined
Haematological findings
effects observed, treatment-related
Clinical biochemistry findings
effects observed, treatment-related
Urinalysis findings
effects observed, treatment-related
Behaviour (functional findings)
no effects observed
Organ weight findings including organ / body weight ratios
effects observed, treatment-related
Gross pathological findings
effects observed, treatment-related
Histopathological findings: non-neoplastic
effects observed, treatment-related
Histopathological findings: neoplastic
not examined
Details on results
CLINICAL SIGNS AND MORTALITY:
Mortality: At 200 mg/kg bw/day, one pregnant female died on GD 22. At 1000 mg/kg bw/day, one nonpregnant female died on day 5 of the administration period, and one pregnant female died on GD23.
Clinical signs: At 200 mg/kg bw/day, transient salivation and soft feces were observed in females. At
1000 mg/kg bw/day, transient salivation, soil of perianal fur, soil of perigenital fur, mucous feces, andsoft feces were observed in males and females.
DETAILED CLINICAL OBSERVATIONS, MANIPULATIVE TEST, GRIP STRENGTH TEST AND LOC
OMOTOR ACTIVITY MEASUREMENT: There were no changes related to the test substance.
BODY WEIGHT:[At the dosing period]: At 1000 mg/kg bw/day, decrease in body weight and body weight gain wereobserved in males.
[At the recovery period]: At 1000 mg/kg bw/day, decrease in body weight was observed in males.
FOOD CONSUMPTION:[At the dosing period]: At 1000 mg/kg bw/day, low value of food consumption was observed in males
at day 3.
13[At the recovery period]: At 1000 mg/kg bw/day, low value of food consumption was observed in females at lactation day 4.
URINALYSIS:[At the dosing period]: At 1000 mg/kg bw/day, low value of urinary pH was observed in both sexes, a
nd increased urinary volume was observed in males at week 6.
HAEMATOLOGY:[At the end of dosing period]: At 1000 mg/kg bw/day, increase in MCV and MCH were observed inmales.
[At the end of recovery period]: There were no changes related to the test substance in any groups.
CLINICAL CHEMISTRY:[At the end of dosing period]: At 1000 mg/kg bw/day, high value of A/G ration, increase in albumin fr
action ratio, and decrease in beta-globulin fraction ratio were observed in males and females, incre
ase in AST, ALT, and decrease in albumin alfa1-globulin ratio, total cholesterol, K, Cl, and IP wereobserved in males, decrease in BUN and Ca were observed in females.
[At the end of recovery period]: There were no changes related to the test substance in any groups.
ORGAN WEIGHTS:[At the end of dosing period]: At 1000 mg/kg bw/day, increase in relative weights of the liver and kidne
y were observed in males and females.
[At the end of recovery period]: There were no changes related to the test substance in any groups.
GROSS PATHOLOGY:[At the end of dosing period]: At 1000 mg/kg bw/day, thickening of forestomach mucosa and th
ickening in limiting ridge of stomach were observed in males and females.
[At the end of recovery period]: There were no changes related to the test substance in any groups.
HISTOPATHOLOGY: NON-NEOPLASTIC:[At the end of dosing period]: At 200 mg/kg bw/day, squamous cell hyperplasia of forestomach wasobserved in males. At 1000 mg/kg bw\/day, squamous cell hyperplasia of forestomach, inflammato
ry cell infiltration in submucosa of forestomach, squamous cell hyperplasia in limiting ridge of sto
mach were observed in males and females, and edema in submucosa of forestomach was observed in females. Spermatogenetic examination of the 1,000 mg/kg bw/day group found a decreased
number of Sertoli cells at stages IX–XIV.
[At the end of recovery period]: At 1000 mg/kg bw/day, squamous cell hyperplasia of forestomach
persisted in 3/5 males and 1/4 female after the end of the recovery period, but the grade had recove
red to a slight level.

Effect levels
Key result
true
Dose descriptor
NOAEL
Effect level40

mg/kg bw/day (actual dose received)

Based ontest mat.
14

Sex
male/female
Basis for effect level
clinical signs
At 200 mg/kg bw/day, transient salivation and soft feces were observed in females.
histopathology: non-neoplastic
At 200 mg/kg bw/day, squamous cell hyperplasia of forestomach was observed in males.
mortality
At 200 mg/kg bw/day, one pregnant female died on GD 22.

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/PDF609-65-4d.pdf

Applicant's summary and conclusion
Executive summary
A combined repeated study of oral-dose toxicity including reproduction/developmental toxicity
screening was performed in accordance with OECD TG 422. Male and female rats (12 animals/sex/dose) were administered 2-chlorobenzoyl chloride at 0 (vehicle: corn oil), 40, 200, and 1,000 mg/kg bw/
day. The males were dosed for 42 days, including a 14-day pre-mating period and a subsequent mating
period. The females were dosed up to 49 days, including 14-day pre-mating, mating, and gestation
periods, and until lactation day 5. Out of the 12 males dosed at 0 and 1,000 mg/kg bw/day, 5 weretreated as a recovery group. Each five additional females at 0 and 1,000 mg/kg bw/day were dosed with
2-chlorobenzoyl chloride for 42 days without mating and examined after a 14-day recovery period.
One pregnant female died on GD 22 and another on GD23, having been administered 200 mg/kg bw/day
and 1,000 mg/kg bw/day, respectively. A non-pregnant female also died on day 5 of the administration
period. Salivation, soft feces, mucus feces, and/or soiling of the peri-genital or anal fur were observedin both sexes at 200 and 1,000 mg/kg bw/day groups. Decreases in body weight, weight gain, andfood consumption were observed in the males of the 1,000 mg/kg bw/day group. Body weight was notaffected by 2-chlorobenzoyl chloride treatment in females, but food consumption decreased during thelactation period for the 1,000 mg/kg bw/day group. The relative organ weights of the liver and kidney
increased in both sexes in the 1,000 mg/kg bw/day group. After the administration period, (slight tosevere) squamous cell hyperplasia of the forestomach was observed at 1,000 mg/kg bw/day for all
animals in both sexes, and an increased tendency was observed in males of the 200 mg/kg bw/day
group. This change persisted in 3/5 males and 1/4 female after the end of the recovery period, but
the grade had recovered to a slight level. Spermatogenetic examination of the 1,000 mg/kg bw/day
group found a decreased number of Sertoli cells at stages IX–XIV. After the recovery period, no adverse
effects were observed, except in the forestomach. Judging from the changes in general condition anddeath at 200 mg/kg bw/day, the NOAEL for the repeated-dose toxicity of 2-chlorobenzoyl chloride wasdetermined to be 40 mg/kg bw/day in rats.

15

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

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Author:Date: 2022-12-16T14:18:48.095+09:00
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Administrative data
Endpoint
in vitro gene mutation study in bacteria
Type of information
experimental study
Adequacy of study
key study
Robust study summary
true
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
guideline study
Reliability 1

Data source
Reference
Reverse Mutation Test of 2-Chlorobenzoyl chloride / Ministry of Health, Labour and Welfare (MHLW),
Japan / study report
Data accessdata published

Materials and methods
Test guideline
Qualifieraccording to guideline
Guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
in vitro gene mutation study in bacteria

16

GLP compliance
yesType of assay
bacterial reverse mutation assay
in vitro gene mutation study in bacteria

Test material
Test material information
2-Chlorobenzoyl chloride
Specific details on test material used for the study- Name of test material (as cited in study report): 2-chlorobenzoyl chloride- Lot No.: GK01 (Tokyo Chemical Industry Co., Ltd.)- Purity: 99.2%- Solubility: soluble in acetone- Physical state: Colorless liquid- Storage condition of test material: in cool (2-8 degree C) and dark place

MethodSpecies / strain
Species / strain / cell typeS. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2bacteria
Metabolic activation
with and without
Metabolic activation system
S9 mix: Rat liver, induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose
Dosage of each strain with or without S9-S9 mix: 0, 78.1, 156, 313, 625, 1250, 2500 and 5000 μg /plate+S9 mix: 0, 156, 313, 625, 1250, 2500 and 5000 μg /plate
Maximum concentration was established based on the result of the preliminary test at concentration
up to 5000 ug/plate. In this test, growth inhibition was observed at 1500 and 5000 μg/plate for all
strains with and without S9 mix.
Vehicle / solvent
AcetoneControls
Untreated negative controlsnoNegative solvent / vehicle controls
yes
True negative controlsno17

Positive controls
yes
Positive control substancesodium azide
without S9 mix (TA 1535)
other: without S9 mix:2-(2-Furyl)-3-(5-nitro -2-furyl)acrylamide (TA100, TA98, WP2uvrA), without S9
mix: 9-Aminoacridine hydrochloride hydrate(TA1537) with 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- Method: other: growth inhibition
Evaluation criteria
A chemical was judged to be mutagenic when the mean number of revertant colonies per plateincreased more than twice that of the negative control and when the dose-related or reproducible increase was observed.
Statistics
not used

Results and discussion
Test results
Key result
trueSpecies / strain
S. typhimurium TA 1535
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity at 1250 μg /plate and higher
Vehicle controls validity
valid
Positive controls validity
valid
Key result
trueSpecies / strain
S. typhimurium TA 1537
bacteria
18

Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity at 1250 μg /plate and higher
Vehicle controls validity
valid
Positive controls validity
valid
Key result
trueSpecies / strain
S. typhimurium TA 98
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity at 1250 μg /plate and higher
Vehicle controls validity
valid
Positive controls validity
valid
Key result
trueSpecies / strain
S. typhimurium TA 100
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity at 1250 μg /plate and higher
Vehicle controls validity
valid
Positive controls validity
valid
Key result
true
19Species / strain
E. coli WP2 uvr A pKM 101
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity Precipitation was observed at 1250 μg /plate and higher
Vehicle controls validity
valid
Positive controls validity
valid
Additional information on results
Precipitation was observed at 1250 μg /plate and higher

Any other information on results incl. tables
Figures and Tables (inEnglish) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF609-65-4e.pdf

Applicant's summary and conclusion
Conclusions
With metabolic activation: Negative
Without metabolic activation: Negative
Executive summary
In a bacterial reverse mutation assay using S. typhimuriumTA100, TA1535, TA98, and TA1537, and E.
coli WP2uvrA/pKM101 (OECD TG 471), negative results were obtained for 2-chlorobenzoyl chloride withor without metabolic activation.

20

ENDPOINT_STUDY_RECORD: Genetic toxicity in vitro.002

UUID: 59b92994-7521-40db-9d85-2ff58564c4b5
Dossier UUID:
Author:Date: 2022-12-12T10:29:50.875+09:00
Remarks:

Administrative data
Endpoint
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information
experimental study
Adequacy of study
key study
Robust study summary
true
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
guideline study
Reliability 1

Data source
Reference
In Vitro Chromosomal Aberration Test of 2-Chlorobenzoyl chloride on Cultured Chinese Hamster Cells /MHLW (Ministry of Health, Labour and Welfare), 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

Qualifieraccording to guideline
Guideline
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
genetic toxicity in vitro, other
GLP compliance
yesType of assay
bacterial reverse mutation assay
in vitro gene mutation study in bacteria

Test material
Test material information
2-Chlorobenzoyl chloride
Specific details on test material used for the study- Name of test material (as cited in study report): 2-chlorobenzoyl chloride- Lot No.: GK01 (Tokyo Chemical Industry Co., Ltd.)- Purity: 99.2%- Solubility: soluble in acetone- Physical state: Colorless liquid- Storage condition of test material: in cool (2-8 degree C) and dark place

MethodSpecies / strain
Species / strain / cell typeother:
Details on mammalian cell type (if applicable)
Chinese hamster lung(CHL/IU) cell
Metabolic activation
with and without
Metabolic activation system
S9 mix: Rat liver, induced with phenobarbital and 5,6- benzoflavone
Test concentrations with justification for top dose
Short-term treatment(+S9 mix): 0, 109, 219, 329, 438, 657, 875 μg/mL
Short-term treatment(-S9 mix): 0, 109, 219, 274, 329, 384, 438 μg/mL
Continuous treatment: 0, 35.5, 55.0, 72.0, 90.0, 91.5, 98.5 μg/mL
Cell-growth inhibition test was conducted up to the limited concentration of 1750 μg/mL (10 mM).
IC50s were determined to be 386 μg/mL (short-term, -S9), 651 μg/mL (short-term, +S9), and 372 μg/
mL (continuous treatment).
Vehicle / solventacetone22

Controls
Untreated negative controlsnoNegative solvent / vehicle controls
yes
True negative controlsnoPositive controls
yes
Positive control substancebenzo(a)pyrene(with S9 mix)
mitomycin C(without S9 mix)
Details on test system and experimental conditions
METHOD OF APPLICATION: Exposure duration: [short-term treatment]:6 h + 18 h, [continuous t
reatment]: 24h
NUMBER OF CELLS EVALUATED: 200 cells /concentration (100 cells/plate x 2)
Plates/test: 2
Evaluation criteria
For the evaluation of the frequencies of structural aberrations and of polyploidy induced, the following
criteria were employed. Appearance incidence of cell with chromosomal aberrations: Negative(-): lessthan 5%, Equivocal(±): 5% or more and less than 10%, Positive(+): 10% or more
Statistics
Not used

Results and discussion
Test results
Key result
trueSpecies / strainother: Chinese hamster lung(CHL/IU) cells
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity >50% growth inhibition was observed at 438 μg/mL (short-term treatment, -S9 mix), 657
μg/mL (short-term treatment, +S9 mix), and 438 μg/mL (continuous treatment)
Vehicle controls validity
valid
Positive controls validity
valid

23

Additional information on results
Precipitation was observed at the beginning and end of treatment for short-term treatment with S9 mi
x at 875 μg/mL. Decreases of pH in culture medium were detected at the beginning of treatment at
384 and 438 μg/mL for all treatment groups, and at the end of treatment at 657 μg/mL for short-term
treatment with S9 mix. In the confirmation tests, 2-Chlorobenzoyl chloride did not induce structural aberrations with and without S9 mix. Polyploidy was not observed in any test conditions. Positive andvehicle control groups were valid.

Any other information on results incl. tables
Figures and Tables (inEnglish) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF609-65-4f.pdf

Applicant's summary and conclusion
Conclusions
In an in vitro chromosomal aberration test using CHL/IU cells (OECD TG 473), negative results were obtained with or without metabolic activation.
Executive summary
In an in vitro chromosomal aberration test using CHL/IU cells (OECD TG 473), negative results wereobtained with or without metabolic activation for 2-Chlorobenzoyl chloride.

24

Toxicity to reproduction
ENDPOINT_STUDY_RECORD: Toxicity to reproduction.001

UUID: dcd79d36-4b12-4bb1-befa-f7c6696e653b
Dossier UUID:
Author:Date: 2022-12-16T14:19:59.337+09:00
Remarks:

Administrative data
Endpoint
reproductive toxicity, other A combined repeated dose/reproductive developmental toxicity study
Type of information
experimental study
Adequacy of study
key study
Robust study summary
false
Used for classification
false
Used for SDS
false
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
guideline study
Reliability 1
Cross-reference
Reason / purpose for cross-reference
reference to same study
Related information
OECD / Repeated dose toxicity: oral / Repeated dose toxicity: oral.001 / 2-Chlorobenzoyl chloride / 2chlorobenzoyl chloride / 609-65-4

Data source
Reference
A combined repeated dose/reproductive developmental toxicity study of 2-chlorobenzoyl chloride byor / Ministry of Health, Labor and Welfare, Japan / study report
Data accessdata published

Materials and methods
25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
2-Chlorobenzoyl chloride
Specific details on test material used for the study- Name of test material (as cited in study report): 2-chlorobenzoyl chloride- Analytical purity: 99.2%- Storage condition of test material: at a cold (temperature 2-10°C) and dark place, with airtightstopper.
- Stability under test conditions: The stability of test material was identified by analysis of theremainder.

Test animals
Speciesrat
Strainother: Crl:CD(SD)Sexmale/female
Details on test animals or test system and environmental conditions
TEST ANIMALS- Source: Charles River Japan, Inc., Atsugi Breeding Center.
- Age at study initiation: 10 weeks old- Weight at study initiation: Male: 398.6 g (366 -432 g), Female: 257.2 g (235-283 g)- Housing: Animals were housed individually, except for during the acclimation (one or two animals
by sex), mating (one male and one female) and lactation periods (one litter), in metallic bracket-type
cages with wire mesh floors (300Wx 410D x 200H mm). From gestation day 17 to lactation day 4, individual dams and litters were reared on bedding.
- Diet: Solid feed (CRF-1: Oriental Yeast Co., ltd.) was given ad libitum.
- Water: Tap water was given ad libitum.
- Acclimation period: 14 days

26

ENVIRONMENTAL CONDITIONS- Temperature (°C): 22±3 (actual temperature: 21-25°C)- Humidity (%): 50±20% (actual humidity: 44-69%)- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light (light: 8:00~20:00)

Administration / exposure
Route of administration
oral: gavage
Vehiclecorn oil
Details on exposure- Amount of vehicle (if gavage): 5 mL/kg- Dosing volume: 5 mL/kg
Analytical verification of doses or concentrations
yes
Duration of treatment / exposure(P) Males: 42 days including 14 days pre-mating(P)Females: 42-49 days including 14 days pre-mating, mating and gestation periods and the days
until day 4 of lactation
Female (no mating, satellite group): 42 days
Frequency of treatment
Once/day, 7 days/week
Doses / concentrations
Dose / conc.
0mg/kg bw/day (actual dose received)

Dose / conc.
40

mg/kg bw/day (actual dose received)

Dose / conc.
200

mg/kg bw/day (actual dose received)

Dose / conc.
1000

mg/kg bw/day (actual dose received)

No. of animals per sex per dose
Main group:12 animals/sex/dose
Satellite (Recovery) group: 5 males/dose and 5 females/dose (0 and 1000 mg/kg bw/day)27

Control animals
yes, concurrent vehicle
Details on study design- Dose selection rationale: Based on the results of a 14-day preliminary study, the highest dose of1000 mg/kg bw/day was selected as an expected obvious toxic dose, and the lowest dose of 40 mg/
kg bw/day was selected as an expected no toxic dose. The middle dose levels of 200 mg/kg bw/day
were selected.
- Rationale for animal assignment (if not random): Body weight-balanced randomization[14-day preliminary study]
A 14-day repeated dose oral toxicity test (Crl:CD(SD) rats, doses: 0 (olive oil), 30, 100, 300 or 1000 mg/
kg bw/day). Thickening of the forestomach mucosa was observed at 300 mg/kg bw/day or more.
At 1000 mg/kg bw/day, decrease in body weight and body weight gain, decrease in food consumpt
ion, decrease in urine pH were observed in males, low value of red blood cell count and hemoglobin
level were observed in females, high value of triglyceride, increase in liver and kidney weights wereobserved in both sexes.

Examinations
Parental animals: Observations and examinations
CAGE SIDE OBSERVATIONS: Yes- Time schedule: 2 times/day (am: before and after administration; pm) during the administration
period. 2 times/day (am and pm) during the recovery period.
DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule: Once before the start of administration, and once every week by the end of the study
period.
BODY WEIGHT: Yes- Time schedule for examinations:
Males were weighed on Day 1, 3, 5, 7, 10, 14, 21, 28, 35, and 42 of administration, and weighed on Day
7 and 14 of recovery.
Female satellite groups were weighted same frequencies to male recovery groups.
Females in the main groups were weighed on Day 1, 3, 5, 7, 10 and 14 of administration andcopulated females were weighed on Day 0, 1, 3, 5, 7, 14, 17 and 20 of gestation, and days 0, 1, and 4 oflactation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption: Yes
Measurement of food consumption was conducted on all animals at the following frequencies:
Males in the main and recovery groups; on Day 1, 3, 5, 7, 10, 14, 21, 28, 35, and 42 of administration,and on Day 7 and 14 of recovery.
Female satellite groups were weighted same frequencies to male recovery groups.
Females in the main group; on Day 1, 3, 5, 7, 10, and 14 of administration and copulated females were
weighed on Day 1, 3, 5, 7, 10, 14, 17 and 20 of gestation, and days 1 and 4 of lactation.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes- Time schedule for collection of blood: At the end of administration period, or at the end of recovery
period in both sexes- Anaesthetic used for blood collection: ether- Animals fasted: Yes- How many animals: 5 animals/sex/group28

- Parameters examined included RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet, reticulocyte, PT, APTT, WBC and differential WBC.
CLINICAL CHEMISTRY: Yes- Time schedule for collection of blood: At the end of administration period, or at the end of recovery
period in both sexes- Animals fasted: Yes- How many animals: 5 animals/sex/group- Parameters examined included total protein, protein fraction, albumin, A/G ratio, total bilirubin,
glucose, total cholesterol, triglyceride, AST, ALT, ALP, gamma-GTP, BUN, creatinine, Na, K, Cl, Ca andIP.
URINALYSIS: Yes- Time schedule for collection of urine: On Week 6 (Day 40-41) of administration, and on Week 2 (Day12-13) of recovery.
- Metabolism cages used for collection of urine: Yes- How many animals: 5 animals/group- Parameters examined included color, urine volume, specific gravity, pH, protein, glucose, ketone
body, bilirubin, occult blood and urobilinogen.
NEUROBEHAVIOURAL EXAMINATION: Yes- Time schedule for examinations: On week 6 of the administration period, and on week 2 of therecovery period- Dose groups that were examined: All dose groups (5 animals/sex/group)- Battery of functions tested: sensory activity (hearing reaction, eye sight reaction, sense of touch
reaction, pain reaction, proprioceptive, righting reflex), grip strength, motor activity
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.
Sperm parameters (parental animals)
Parameters examined in all P male parental generations: testis weight, epididymis weight, histopatho
logical examinations for testes, epididymides, seminal vesicle including coagulating gland and ventral
prostate.
Stages of spermatogenesis examined in male control group and 1000 mg/kg bw/day group.
Litter observations
PARAMETERS EXAMINED: The following parameters were examined in F1 offspring: number and sexof pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physicalor behavioral abnormalities.
Postmortem examinations (parental animals)
METHOD OF SACRIFICED: All animals were sacrificed by exsanguination under ether anesthesia.
SACRIFICE: Male animals: On Day 42, Maternal animals: on Day 6 of lactation, and Male recovery andfemale satellite animals: on next Day 14 of recovery.
GROSS PATHOLOGY: Yes
ORGAN WEIBHT: Yes [brain, thymus, heart, liver, kidney, adrenal gland, spleen, testis, epididymis]
HISTOPATHOLOGY: Yes, [brain, pituitary, spinal cord, thyroid, parathyroid, heart, thymus, trachea, lu
ng, liver, kidney, adrenal, spleen, esophagus, stomach, pancreas, duodenum, jejunum, ileum, cecum, colon, rectum, eyeball and Harderian gland, sciatic nerve, bone, bone marrow, lymph nodes (mesentericand mandibular lymph nodes), urinary bladder, testis, seminal vesicle, prostate, epididymis, mammary
gland, ovary and uterus.]
29

Postmortem examinations (offspring)
SACRIFICE- The F1 offspring were sacrificed at 4 days of age.
GROSS NECROPSY- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, andabdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGTHS- Not examined.
Statistics
The data were analyzed for homogeneity of variance by the Bartlett test. If variances were
homogeneous, data was analyzed by one-way ANOVA and the Dunnett test, whereas heterogeneous
data was analyzed by Kruskal-Wallis test and the Mann-Whitney U test.
For findings two or more grades was observed, data was analyzed by Kruskal-Wallis test and the Ma
nn-Whitney U test. For findings one grade was observed, data was analyzed by a multi-sample chisquare test and a two-sample chi-square test. For the comparison tests with the control group, thesignificance level was 5%.
Reproductive indices
Estrous cycle: Mean estrous cycle
Copulation index (%) = (No. of pairs with successful copulation/No. of pairs mated) × 100
Fertility index (%) = (No. of pregnant females/No. of pairs with successful copulation) × 100
Gestation index (%) = (No. of females with live pups/No. of pregnant females) × 100
Implantation index (%) = (No. of implantation sites/No. of corpora lutea) × 100
Delivery index (%) = (No. of pups born/No. of implantation sites) × 100
Live birth index (%) = (No. of live pups on day 0/No. of pups born) × 100
Sex ratio =Total number of male pups/Total number of female pups
Nursing index (%) = (No. of females nursing live pups on lactation day 4/No. of females with live pupsdelivery) × 100

Offspring viability indices
Viability index (%) = (No. of live pups on day 4/No. of live pups on day 0) × 100

Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
Clinical signs
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Mortality
mortality observed, treatment-related
Description (incidence)See 7.5.1
30

Body weight and weight changes
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Food consumption and compound intake (if feeding study)
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Food efficiency
not examined
Water consumption and compound intake (if drinking water study)
not examined
Ophthalmological findings
not examined
Haematological findings
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Clinical biochemistry findings
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Urinalysis findings
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Behaviour (functional findings)
no effects observed
Immunological findings
not examined
Organ weight findings including organ / body weight ratios
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Gross pathological findings
effects observed, treatment-related
Description (incidence and severity)
See 7.5.1
Neuropathological findings
not examined
Histopathological findings: non-neoplastic
effects observed, treatment-related31Description (incidence and severity)
See 7.5.1
Histopathological findings: neoplastic
not examined

Reproductive function / performance (P0)
Reproductive function: oestrous cycle
effects observed, treatment-related
Description (incidence and severity)
An increased tendency was found for abnormal estrus cyclicity at 1,000 mg/kg bw/day.
Reproductive function: sperm measureseffects observed, treatment-related
Description (incidence and severity)
Spermatogenetic examination of the 1,000 mg/kg bw/day group found a decreased number of Sertoli
cells at stages IX–XIV.
Reproductive performance
effects observed, treatment-related
Description (incidence and severity)
At 200 mg/kg bw/day, one pregnant female died on GD 22. At 1000 mg/kg bw/day, one pregnant
female died on GD23.
A decreased tendency was found for the fertility index at 1,000 mg/kg bw/day.

Effect levels (P0)
Key result
true
Dose descriptor
NOAEL
Effect level40

mg/kg bw/day (actual dose received)

Based ontest mat.
Sexmale/female
Basis for effect level
reproductive performance
One pregnant female died on GD 22 at 200 mg/kg bw/day.

Results: F1 generation
General toxicity (F1)Clinical signs
no effects observed32Mortality / viability
no mortality observed
Body weight and weight changes
effects observed, treatment-related
Description (incidence and severity)
Low values of body weights of male and female pups were observed on PND 0, 1, and 4 at 1000 mg/
kg bw/day.
Gross pathological findings
no effects observed

Effect levels (F1)
Key result
true
Dose descriptor
NOAEL
Generation
F1
Effect level200

mg/kg bw/day (actual dose received)

Based ontest mat.
Sexmale/female
Basis for effect level
body weight and weight gain
Low values of body weights of male and female pups were observed on PND 0, 1, and 4 at 1000
mg/kg bw/day.

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/PDF609-65-4d.pdf

Applicant's summary and conclusion
Executive summary
The above-described combination of repeated oral-dose toxicity research and of a reproduction/
developmental toxicity screening test (OECD TG 422), included observations of deaths in each one dam,
before or during the delivery at 200 or 1,000 mg/kg bw/day, which was considered to be reproduction
toxicity. Further, an increased tendency was found for abnormal estrus cyclicity and a tendency of
decrease in the fertility index at 1,000 mg/kg bw/day. The body weights of the male and female pups
were lower on PND 0, 1, and 4 at 1,000 mg/kg bw/day. The maternal death at 200 mg/kg bw/day leads to33

the conclusion that the NOAEL for rat reproduction/developmental toxicity of 2-chlorobenzoyl chloride
is 40 mg/kg bw/day.

34

DOMAIN
Substance
SUBSTANCE: 2-Chlorobenzoyl chloride
UUID: 4b13eca6-c0a4-400d-b113-88278d1a3219
Dossier UUID:
Author:Date: 2022-12-16T14:19:59.337+09:00
Remarks:
Substance name2-Chlorobenzoyl chloride
Legal entity
National Institute of Health Sciences / Kawasaki / Japan

Identification of substance
Reference substance2-chlorobenzoyl chloride / 2-chlorobenzoyl chloride / 609-65-4 / 210-194-0
EC number

EC name210-194-0

EC Inventory

CAS number

CAS name609-65-4
IUPAC name2-chlorobenzoyl chloride

Role in the supply chain
Manufacturer
false
Importer
false
Only representativefalse
Downstream user
false

35

References
Reference Substances
REFERENCE_SUBSTANCE: 2-chlorobenzoyl chloride
UUID: ECB5-221169d3-09a9-42f6-8b52-bdcafa61e7fe
Dossier UUID:
Author:Date: 2007-05-10T18:00:00.000+09:00
Remarks:
Reference substance name2-chlorobenzoyl chloride
IUPAC name2-chlorobenzoyl chloride

Inventory
Inventory number
Inventory name2-chlorobenzoyl chloride
Inventory
EC Inventory
Inventory number
210-194-0
CAS number
609-65-4
Molecular formula
C7H4Cl2O
Description
CAS number
609-65-4

Synonyms
Synonyms
Identity
Benzoyl chloride, 2-chloroIdentity
Benzoyl chloride, 2-chloro-

Molecular and structural information
36

Molecular formula
C7H4Cl2O
Molecular weight
175.0121
SMILES notation
ClC(=O)c1ccccc1Cl
InChl
InChI=1/C7H4Cl2O/c8-6-4-2-1-3-5(6)7(9)10/h1-4H
Structural formula

Related substancesGroup / category information
USEPA Category: Acid Chlorides;Neutral Organics

37

Test Materials
TEST_MATERIAL_INFORMATION: 2-Chlorobenzoyl
chloride
UUID: 00e78d28-5a54-4588-be11-005ce8de3158
Dossier UUID:
Author:Date: 2022-12-12T10:20:07.866+09:00
Remarks:
Name
2-Chlorobenzoyl chloride

38

Literatures
LITERATURE: A combined repeated dose/reproductive
developmental toxicity study of 2-chlorobenzoyl chloride
by oral administration in rats.
UUID: 552d9d44-22d6-4679-bd2e-2c8f187c02a0
Dossier UUID:
Author:Date: 2019-03-22T10:19:39.000+09:00
Remarks:

General information
Reference Typestudy report
Title
A combined repeated dose/reproductive developmental toxicity study of 2-chlorobenzoyl chloride byoral administration in rats.
Author
Ministry of Health, Labor and Welfare, Japan
Bibliographic source
Japan Existing Chemical Data Base (JCDB)
Testing facility
Safety Research Institute Chemical Compounds Co., Ltd.
Report number
SR06171

39

LITERATURE: In Vitro Chromosomal Aberration Test of
2-Chlorobenzoyl chloride on Cultured Chinese Hamster
Cells
UUID: 85a292dc-4187-4c03-a1e3-8130c942bfac
Dossier UUID:
Author:Date: 2019-02-15T17:10:51.000+09:00
Remarks:

General information
Reference Typestudy report
Title
In Vitro Chromosomal Aberration Test of 2-Chlorobenzoyl chloride on Cultured Chinese Hamster
Cells
AuthorMHLW (Ministry of Health, Labour and Welfare), Japan
Bibliographic source
http://dra4.nihs.go.jp/mhlw_data/jsp/SearchPageENG.jsp
Testing facility
Safety Research Institute for Chemical Compounds Co., Ltd

40

LITERATURE: Reverse Mutation Test of 2-Chlorobenzoyl
chloride
UUID: 1b10b74b-81a1-455a-92f3-a2b96ee77776
Dossier UUID:
Author:Date: 2019-02-15T16:58:29.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Reverse Mutation Test of 2-Chlorobenzoyl chloride
Author
Ministry of Health, Labour and Welfare (MHLW), Japan
Bibliographic source
http://dra4.nihs.go.jp/mhlw_data/jsp/SearchPageENG.jsp
Testing facility
Safety Research Institute for Chemical Compounds Co., Ltd

41

LITERATURE: Single Dose Oral Toxicity Test of 2Chlorobenzoyl chloride
UUID: 3f8d7050-a419-445a-a0b8-38a443c649df
Dossier UUID:
Author:Date: 2019-02-15T15:47:07.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Single Dose Oral Toxicity Test of 2-Chlorobenzoyl chloride
AuthorMHLW (Ministry of Health, Labour and Welfare), Japan
Bibliographic source
http://dra4.nihs.go.jp/mhlw_data/jsp/SearchPageENG.jsp
Testing facility
Safety Research Institute for Chemical Compounds Co., Ltd42

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 systemIUCLID443

ID
16558402024DIV750

44