Name: COMPLETE / SUBSTANCE : 1,2-Ethanediyl ester octadecanoic acid / 627-83-8 Tue,
5 Sep 2023, 13:39:24+0900 /Legal entity owner: National Institute of Health Sciences / Kawasaki / Japan
Printing date: 2023-09-05T13:39:24.911+09:00

iTable of Contents
0/0 ............................................................................................................................. 1
National Institute of Health Sciences .................................................................... 2
1,2-Ethanediyl ester octadecanoic acid ................................................................. 4
OECD .......................................................................................................... 4
D Health Effects .................................................................................. 4
67 Repeated dose toxicity: oral .................................................... 4
RepeatedDoseToxicityOral. .................................................. 470 Genetic toxicity in vitro ......................................................... 13
Genetic toxicity in vitro.001 ................................................ 13
Genetic toxicity in vitro.002 ................................................ 18
73 Toxicity to reproduction ........................................................ 22
ToxicityReproduction. ........................................................ 22
DOMAIN .................................................................................................... 32
1,2-Ethanediyl ester octadecanoic acid ............................................... 32
References ................................................................................................................ 33
Reference Substances ...................................................................................... 33
1,2-Ethanediyl ester octadecanoic acid ....................................................... 33
Test Materials .................................................................................................. 34
1,2-Ethanediyl ester octadecanoic acid ....................................................... 34
Literatures ....................................................................................................... 35
Combined repeated dose toxicity study with the reproductive/
developmental toxicity screening test of 1,2-ethanediyl ester octadecanoic
acid by oral administration in rats .............................................................. 35
In Vitro Chromosomal Aberration Test of 1,2-Ethanediyl ester
octadecanoic acid on Cultured Chinese Hamster Cells. ................................ 36
Reverse Mutation Test of 1,2-Ethanediyl ester octadecanoic acid on
Bacteria. ................................................................................................... 37ii

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Dossier subject
Dossier subject
1,2-Ethanediyl ester octadecanoic acid / 627-83-8
Public nameSubmitting legal entity
National Institute of Health Sciences / Kawasaki / Japan
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Tue, 5 Sep 2023, 13:39:24+0900
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LEGAL_ENTITY: National Institute of Health
Sciences
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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 systemIUCLID42

ID
16558402024DIV750

3

1,2-Ethanediyl ester octadecanoic acid
OECD
Health Effects
Repeated dose toxicity: oral
ENDPOINT_STUDY_RECORD: RepeatedDoseToxicityOral.

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Administrative data
Endpoint
short-term repeated dose toxicity: oral
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 OECD Test Guideline study under GLP condition
Reliability 1
Cross-reference
Reason / purpose for cross-reference
reference to same study
Related information
OECD / Toxicity to reproduction / ToxicityReproduction. / 1,2-Ethanediyl ester octadecanoic acid /627-83-8

Data source
Reference
Combined repeated dose toxicity study with the reproductive/developmental toxicity screening test of /Ministry of Health, Labour and Welfare (MHLW), Japan / study report4Data accessdata published https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF627-83-8d.pdf

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
1,2-Ethanediyl ester octadecanoic acid
Specific details on test material used for the study- Name of test material (as cited in study report): Octadecanoic acid, 1,2-ethanediyl ester- Analytical purity: 99.99% (Solid content as a mixture of long-chain fatty acid esters mainly oct
adecanoic acid)- Storage condition of test material: sealed, cool and dark place (2-8°C)- Stability under test conditions: The stability of test material was identified by analysis of theremainder.

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: 405 g (380-446 g), Female: 250 g (222-285 g)- Housing: Animals were individually housed in bracket-type metallic wire-mesh cages (254W × 350D
× 170H mm), from gestation day 17 to lactation day 4, Dams were bred individually or with individual
littermates in plastic cages (340W x 400D x 185H mm) and bedding.
- Diet: Solid feed (NMF: Oriental Yeast Co., ltd.) was given ad libitum.
5

- Water: Tap water was given ad libitum.
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 23±3 (actual temperature: 22-25°C)- Humidity (%): 50±20% (actual humidity: 40-55%)- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light (light: 7:00~19:00)

Administration / exposure
Route of administration
oral: gavage
Vehiclemethylcellulose 0.5w/v%
Details on oral exposure- Amount of vehicle (if gavage): 5 mL/kg- Dosing volume: 5 mL/kg
Analytical verification of doses or concentrations
yes
Details on analytical verification of doses or concentrations
The concentration of each suspensions used in weeks 1 and 6 of administration were analyzed by
GC. Results showed that the concentrations of each suspensions were 96.0 to 110.0% of the nominal
concentration and both values were within the acceptable range (concentration: percentage of nomi
nal concentration, 100±10%)Duration of treatment / exposure(P) Males: 42 days including 14 days pre-mating(P)Females: 41-46 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.
100

mg/kg bw/day (actual dose received)

Dose / conc.
300

mg/kg bw/day (actual dose received)

Dose / conc.
1000

mg/kg bw/day (actual dose received)

No. of animals per sex per dose
Mating group: 12 animals/sex/dose (0, 100, 300 and 1000 mg/kg bw/day)
Non-mating group: 10 females/dose (0 and 1000 mg/kg bw/day)6

Recovery group: 5 males/dose in the mating group and 5 females/dose in the non-mating groups (0and 1000 mg/kg bw/day)Control animals
yes, concurrent vehicle
Details on study design- Dose selection rationale: Based on the results of a 14-day preliminary study, the high dose was set to1000 mg/kg bw/day, which is the upper limit in OECD TG422, and the intermediate dose and low dosewere set to 300 mg/kg bw/day and 100 mg/kg bw/day, respectively.
[14-day preliminary study]
A 14-day repeated dose oral toxicity test (Crl:CD(SD) rats, doses: 0, 250, 500 or 1000 mg/kg bw/day).
There were no deaths in the high-dose 1000 mg/kg bw/day group. However, decreased total prot
ein was observed in males at 250 mg/kg bw/day and above, increased relative heart weight wasobserved in males at 1000 mg/kg bw/day, and increased hematocrit and total protein were observedin females at 1000 mg/kg bw/day.
- Rationale for animal assignment (if not random): Body weight-balanced randomization.

Examinations
Observations and examinations performed and frequency
CAGE SIDE OBSERVATIONS: Yes- Time schedule: 3 times/day (before administration, immediately after administration and 1-3 hours
after administration) during the administration period. Once a day during the recovery period.
DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule:
Males in the main groups and females in the non-mating groups: once before the start of admin
istration, once every weekly during the administration.
Females in the mating groups: once before the start of administration, days specified during mating,gestation, and lactation (mated animals: gestation days 1, 7, 14 and 20, parturient animals: lactation
day 4)
Males and females in the recovery groups: once before the start of administration, once every weekly
during the administration and recovery periods.
BODY WEIGHT: Yes- Time schedule for examinations:
Males in the main groups and females in the non-mating groups: days 1, 8, 15, 22, 29, 36 and 42 ofadministration and on the day of necropsy
Males and females in the recovery groups: days 1, 8, 15, 22, 29, 36 and 42 of administration, and days
1, 8 and 14 of recovery and on the day of necropsy.
Females in the mating groups: days 1, 8 and 15 of administration, days 0, 7, 14, and 20 of gestation,days 0, 4 of lactation, and on 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 and females in the non-mating groups: days 1, 8, 15, 30, 36 and 42 of admi
nistration
Males and females in the recovery groups: days 1, 8, 15, 30, 36 and 42 of administration, and days 1, 8
and 14 of recovery
Females in the mating groups: days 1, 8 and 15 of administration, days 1, 7, 14, and 20 of gestation,days 2 and 4 of lactation
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
7

- 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: Isoflurane- 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 percentag
e, 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.
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 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 OF MALES: Yes- Time schedule for collection of urine: final week of administration (days 36 to 37 of administration)and in the final week of recovery (days 8 to 9 of recovery)- Metabolism cages used for collection of urine: Yes
A urine collector to collect four-hour urine samples under fasting but ad libitum drinking conditions,followed by collection of 20-hour urine samples under ad libitum feeding and drinking conditions.
- How many animals: 5 animals/group- Parameters checked: pH, protein, ketones, glucose, occult blood, bilirubin, urobilinogen, color, sedim
ent, urine volume (4-hour volume), osmotic pressure, sodium, potassium, chloride, urine volume (20-hour volume), water intake (24-hour volume)
BLOOD HORMONE: No
NEUROBEHAVIOURAL EXAMINATION: Yes- Time schedule for examinations:
Males in the main groups and females in the non-mating groups: final week of administration (day 41of administration)
Females in the mating groups: lactation day 4 (day 41 to day 43 of administration) after necropsy of
F1 pupsMales and females in the recovery groups: final week of administration (day 41 of administration) andin the final week of recovery (day 13 of recovery).
- Dose groups that were examined: All dose groups (5 animals/sex/group)- Battery of functions tested:
1) Manipulative Test. Auditory response, approach response, touch response, tail pinch response,
pupillary reflex, aerial righting reflex, landing foot splay
2) Measurement of Grip Strength. Following manipulative test, grip strength of forelimb and hind limb
were measured by CPU gauge MODEL-RX-5 (AIKOH Engineering Co., Ltd.).
3) Measurement of Motor Activity. Following measurement of grip strength, motor activity wasmeasured by a motor activity sensor for experimental animals NS-AS01 (Neuro Science, Inc.). The
measurement was conducted for 1 hour, and measured values at 10-minute intervals and from 0 to
60 minutes were collected.
Sacrifice and pathology
GROSS PATHOLOGY: Yes
ORGAN WEIGHT: Yes [brain, pituitary, thyroids (including parathyroids), adrenal gland, thymus, spleen,
heart, liver, kidney, testis, epididymis, prostate, seminal vesicles, ovary, uterus]
8HISTOPATHOLOGY: Yes, [cerebrum, cerebellum (including pons), sciatic nerve, spinal cord (thoracic),eye ball, optic nerve, Harderian gland, pituitary, thyroid, parathyroid, adrenal glands, thymus, spleen,submandibular lymph nodes, mesenteric lymph nodes, heart, thoracic aorta, trachea, lung (including
bronchial), tongue, larynx, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum,
submandibular gland, sublingual gland, liver, pancreas, kidney, bladder, testis, ovary, epididymis, uterus, vagina, prostate, seminal vesicles, skin (inguinal), mammary gland (inguinal), sternum and fe
mur (including bone marrows), skeletal muscle of femur, and individual identification site (pinna with
ear tag)]
Statistics
For quantitative data, homogeneity of variance was tested using Bartlett method first. If the variance
was homogenous, statistical difference between each treatment group and the control group was
analyzed using Dunnett method. If not homogenous, statistical difference between each treatmentgroup and the control group was tested using Steel method. For comparison of quantitative data be
tween two groups in the recovery test, homogeneity of variance was analyzed by F-test. Then, if homo
genous, student's t-test was applied. If not homogenous, Aspin-Welch's t-test was used.
Regarding clinical observation (except for frequency of urination, defecation, rearing and grooming)and sensory reactivity, Steel test was applied. Regarding auditory response, approach response, touch
response, tail pinch response, pupillary reflex, aerial righting reflex, Fisher's test was applied.

Results and discussion
Results of examinations
Clinical signs
no effects observed
Mortality
no mortality observed
Body weight and weight changes
no effects observed
Food consumption and compound intake (if feeding study)no effects observed
Food efficiency
not examined
Water consumption and compound intake (if drinking water study)
not examined
Ophthalmological findings
not examined
Haematological findings
no effects observed
Clinical biochemistry findings
no effects observed
Urinalysis findings
no effects observed
Behaviour (functional findings)
no effects observed
9Immunological findings
not examined
Organ weight findings including organ / body weight ratios
no effects observed
Gross pathological findings
no effects observed
Neuropathological findings
not examined
Histopathological findings: non-neoplastic
no effects observed
Histopathological findings: neoplastic
not examined
Details on results
CLINICAL SIGNS AND MORTALITY:
Mortality: There was no death.
Clinical signs:
There were no changes related to the test substance in any groups at the dosing and recovery
periods.
DETAILED CLINICAL OBSERVATIONS:
There were no changes related to the test substance in any groups at the dosing and recovery pe
riods.
BODY WEIGHT:
There were no changes related to the test substance in any groups at the dosing and recovery perio
ds.
FOOD CONSUMPTION:
There were no changes related to the test substance in any groups at the dosing and recovery per
iods.
URINALYSIS:There were no changes related to the test substance in any groups at the dosing and recovery periods.
HAEMATOLOGY:
There were no changes related to the test substance in any groups at the end of dosing and recovery
periods.
CLINICAL CHEMISTRY:
There were no changes related to the test substance in any groups at the end of dosing and recovery
periods.
NEUROBEHAVIOURAL EXAMINATION:
1) MANIPULATIVE TEST:
There were no changes related to the test substance in any groups at the dosing and recovery periods.
2) GRIP STRENGTH TEST:
There were no changes related to the test substance in any groups at the dosing and recovery
periods.
3) LOCOMOTOR ACTIVITY MEASUREMENT:
There were no changes related to the test substance in any groups at the dosing and recovery pe
riods.
10

ORGAN WEIGHTS:
There were no changes related to the test substance in any groups at the end of dosing and recovery
periods.
GROSS PATHOLOGY:
There were no changes related to the test substance in any groups at the end of dosing and recovery
periods.
HISTOPATHOLOGY: NON-NEOPLASTIC:
There were no changes related to the test substance in any groups at the end of dosing and recovery
periods.

Effect levels
Key result
true
Dose descriptor
NOAEL
Effect level1000

mg/kg bw/day (actual dose received)

Based ontest mat.
Sexmale/female

Any other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF627-83-8d.pdf

Applicant's summary and conclusion
Conclusions
The NOAEL for repeated dose toxicity in this study was determined to be1000 mg/kg bw/day formales and females.
Executive summary
In the combined repeated dose and reproductive/developmental screening test (OECD TG422), SD rats
were treated orally with 1,2-ethanediyl ester octadecanoic acid at the doses of 0, 100, 300 and 1000
mg/kg bw/day. Males (12 males/dose: 5 males were treated as a recovery group) were dosed for 42days including a 14 day pre-mating period and mating periods. Mating females (12 females/dose) were
dosed for 41-46 days including 14 day premating, mating, and gestation periods and days until day 4of lactation. Non-mating female (10 females/dose: 5 females were treated as a recovery group) were
dosed for 42 days.
As a result, no deaths were observed, and no effects of the test substance administration were observedin any of the examination. Based on the above results, NOAEL for the repeated dose toxicity of 1,211

ethanediyl ester octadecanoic acid was determined to be 1000 mg/kg bw/day for males and female
rats.

12

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

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Author:Date: 2022-03-10T13:26:23.000+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
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 1,2-Ethanediyl ester octadecanoic acid on Bacteria. / 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
13

Deviations
no
Qualifieraccording to guideline
Guideline
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
genetic toxicity in vitro, otherDeviationsno
GLP compliance
yesType of assay
bacterial reverse mutation assay
in vitro gene mutation study in bacteria

Test material
Test material information
1,2-Ethanediyl ester octadecanoic acid
Specific details on test material used for the study- Name of test material (as cited in study report): Octadecanoic acid, 1,2-ethanediyl ester

MethodSpecies / strain
Species / strain / cell typeS. typhimurium TA 1535, TA 1537, TA 98 and TA 100
bacteria
Species / strain / cell type
E. coli WP2 uvr A
bacteria
Metabolic activation
with and without
Metabolic activation system
S9 mix; SD male rat liver, induced by phenobarbital and 5,6-benzoflavone
Justification for deviation from the high dose level-S9 mix:
4.88, 9.77, 19.5, 39.1, 78.1 μg/plate (All strains)+S9 mix:
19.5, 39.1, 78.1, 156, 313 μg/plate (All strains)
Maximum concentration was established based on the result of the preliminary test at concentration
up to 5000 ug/plate. In this test, In this study, no growth inhibition was observed in either strain with or without metabolic activation, so the lowest dose at which the test substance precipitated was usedas the highest dose, with 5 doses in the range of 4.88 - 78.1 μg/plate for no metabolic activation and5 doses in the range of 19.5 - 313 μg/plate for metabolic activation.
14

Vehicle / solvent- Vehicle(s)/solvent(s) used: Tetrahydrofuran (THF)
Controls
Untreated negative controlsnoNegative solvent / vehicle controls
yes
True negative controlsnoPositive controls
yes
Positive control substanceother: -S9 mix: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide (AF-2), sodium azide (SAZ) and 2-methoxy-6chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine 2HCl (ICR-191) ;+S9 mix: 2-aminoanthracene (2AA), benzo[a]pyrene (B[a]P)
Details on test system and experimental conditions
METHOD OF APPLICATION: plate incorporation
DURATION- Preincubation period: 9 hrs at 37°C
- Exposure duration:48 or 50 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 and reproducible increase was observed.
StatisticsnoResults and discussion
Test results
Key result
trueSpecies / strain
S. typhimurium TA 1535
bacteria
Metabolic activation
with and without
Genotoxicity
negative
15

Cytotoxicity / choice of top concentrations
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity
valid
Positive controls validity
valid
Key result
trueSpecies / strain
S. typhimurium TA 1537
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
no cytotoxicity, but tested up to precipitating concentrations
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
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity
valid
Positive controls validity
valid
Key result
trueSpecies / strain
S. typhimurium TA 100
bacteria
16

Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity
valid
Positive controls validity
valid
Key result
trueSpecies / strain
E. coli WP2 uvr A
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity
valid
Positive controls validityvalid

Any other information on results incl. tables
Figures and Tables (in Japanese) are available in the following full report of the study.
https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF627-83-8e.pdf
Please also see the attached files (Tables in English)

Applicant's summary and conclusion
Conclusions
Interpretation of results (migrated information): negative
In a bacterial reverse mutation assay using Salmonella typhimurium TA100, TA1535, TA98, and TA
1537, and Escherichia coli WP2uvrA (OECD TG 471), 1,2-ethanediyl ester octadecanoic acid was ne
gative with or without metabolic activation.

17

ENDPOINT_STUDY_RECORD: Genetic toxicity in vitro.002

UUID: fb8b8e4b-f1d4-4958-a283-53ed461f9d90
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Author:Date: 2022-03-25T11:11:57.000+09:00
Remarks:

Administrative data
Endpoint
in vitro chromosome aberration study in mammalian cells
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
other: OECD Test Guideline study under GLP condition

Data source
Reference
In Vitro Chromosomal Aberration Test of 1,2-Ethanediyl ester octadecanoic acid on Cultured Chinese
H / Ministry of Health, Labour and Welfare (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)18

in vitro cytogenicity / chromosome aberration study in mammalian cells
Deviations
no
Qualifieraccording to guideline
Guideline
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
genetic toxicity in vitro, otherDeviationsno
GLP compliance
yesType of assay
other: in vitro mammalian chromosome aberration test

Test material
Test material information
1,2-Ethanediyl ester octadecanoic acid
Specific details on test material used for the study- Name of test material (as cited in study report): Octadecanoic acid, 1,2-ethanediyl ester

MethodSpecies / strain
Species / strain / cell typeother: Chinese hamster lung (CHL/IU) cells
Metabolic activation
with and without
Metabolic activation system
S9 mix; SD male rat liver, induced by phenobarbital and 5,6-benzoflavone
Justification for deviation from the high dose level
Cell growth inhibition study-S9 mix (short-term treatment): 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 ug/mL+S9 mix (short-term treatment): 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 ug/mL-S9 mix (continuous treatment, 24hr): 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 ug/mL-S9 mix (continuous treatment, 48hr): 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 ug/mL
Main study-S9 (short-term treatment): 1250, 2500, 5000 ug/mL+S9 (short-term treatment): 1250, 2500, 5000 ug/mL-S9 (continuous treatment, 24hr): 1480, 2220, 3330, 5000 ug/mL-S9 (continuous treatment, 48hr): 1480, 2220, 3330, 5000 ug/mL
Vehicle / solvent- Vehicle(s)/solvent(s) used: 0.5%CMC Na
19

Controls
Untreated negative controlsnoNegative solvent / vehicle controls
yes
True negative controlsnoPositive controls
yes
Positive control substanceother: [-S9]: mitomycin C; [+S9]: cyclophosphamide
Details on test system and experimental conditions
METHOD OF APPLICATION:
Exposure duration:- [short-term treatment]: 6 hrs + 18 hrs- [continuous treatment]: 24, 48 hrs
SPINDLE INHIBITOR: Colcemid
STAIN: Giemsa stain (2 v/v%) for 15 min.
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 + 100 cells /concentration
DETERMINATION OF CYTOTOXICITY- Method: relative total growth
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 (-):
less than 5%, Equivocal(±): more than 5% and less than 10%, Positive(+): 10% and above
StatisticsnoResults 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
other: Short-term treatment (+/-S9 mix): no cytotoxicity; Continuous treatment (24hr/48hr): cytot
oxicity20

Vehicle controls validity
valid
Positive controls validity
valid
Additional information on results
RANGE-FINDING/SCREENING STUDIES (if applicable):
50% cell growth inhibition (IC50): 3372 ug/mL (continuous treatment, 48hr)

Any other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF627-83-8f.pdf

Applicant's summary and conclusion
Conclusions
Interpretation of results (migrated information): negative with or without metabolic activation
In an in vitro chromosomal aberration test using CHL/IU cells (OECD TG 473), 1,2-ethanediyl ester
octadecanoic acid was negative with or without metabolic activation.

21

Toxicity to reproduction
ENDPOINT_STUDY_RECORD: ToxicityReproduction.

UUID: 9de6b42d-f271-400e-9da1-ac629fa13a40
Dossier UUID:
Author:Date: 2022-03-25T11:30:17.000+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 OECD Test Guideline study under GLP condition
Reliability 1
Cross-reference
Reason / purpose for cross-reference
reference to same study
Related information
OECD / Repeated dose toxicity: oral / RepeatedDoseToxicityOral. / 1,2-Ethanediyl ester octadecanoic
acid / 627-83-8

Data source
Reference
Combined repeated dose toxicity study with the reproductive/developmental toxicity screening test of /Ministry of Health, Labour and Welfare (MHLW), Japan / study report
Data accessdata published https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF627-83-8d.pdf

Materials and methods
22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
1,2-Ethanediyl ester octadecanoic acid
Specific details on test material used for the study- Name of test material (as cited in study report): Octadecanoic acid, 1,2-ethanediyl ester- Analytical purity: 99.99% (Solid content as a mixture of long-chain fatty acid esters mainly oc
tadecanoic acid)- Storage condition of test material: sealed, cool and dark place (2-8°C)- 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: 405 g (380-446 g), Female: 250 g (222-285 g)- Housing: Animals were individually housed in bracket-type metallic wire-mesh cages (254W × 350D
× 170H mm), from gestation day 17 to lactation day 4, Dams were bred individually or with individual
littermates in plastic cages (340W x 400D x 185H mm) and bedding.
- Diet: Solid feed (NMF: Oriental Yeast Co., ltd.) was given ad libitum.
- Water: Tap water was given ad libitum.
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 23±3 (actual temperature: 22-25°C)- Humidity (%): 50±20% (actual humidity: 40-55%)- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light (light: 7:00~19:00)
23

Administration / exposure
Route of administration
oral: gavage
Vehicleother: 0.5w/v% methylcellulose
Details on exposure- Amount of vehicle (if gavage): 5 mL/kg- Dosing volume: 5 mL/kg
Details on mating procedure- M/F ratio per cage:1/1- Length of cohabitation: up to 5 days
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
Analytical verification of doses or concentrations
yes
Details on analytical verification of doses or concentrations
The concentration of each suspensions used in weeks 1 and 6 of administration were analyzed by
GC. Results showed that the concentrations of each suspensions were 96.0 to 110.0% of the nominal
concentration and both values were within the acceptable range (concentration: percentage of nomi
nal concentration, 100±10%)Duration of treatment / exposure(P) Males: 42 days including 14 days pre-mating(P)Females: 41-46 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.
100

mg/kg bw/day (actual dose received)

Dose / conc.
300

mg/kg bw/day (actual dose received)

Dose / conc.
1000

mg/kg bw/day (actual dose received)

No. of animals per sex per dose
Mating group: 12 animals/sex/dose (0, 100, 300, and 1000 mg/kg bw/day)24

Non-mating group: 10 females/dose (0 and 1000 mg/kg bw/day)Recovery group: 5 males/dose in the mating group and 5 females/dose in the non-mating groups (0and 1000 mg/kg bw/day)Control animals
yes, concurrent vehicle
Details on study design- Dose selection rationale: Based on the results of a 14-day preliminary study, the high dose was set to1000 mg/kg bw/day, which is the upper limit in OECD TG422, and the intermediate dose and low dosewere set to 300 mg/kg bw/day and 100 mg/kg bw/day, respectively.
[14-day preliminary study]
A 14-day repeated dose oral toxicity test (Crl: CD (SD) rats, doses: 0, 250, 500 or 1000 mg/kg bw/day).
There were no deaths in the high-dose 1000 mg/kg bw/day group. However, decreased total protein
was observed in males at 250 mg/kg bw/day and above, increased relative heart weight was obser
ved in males at 1000 mg/kg bw/day, and increased hematocrit and total protein were observed infemales at 1000 mg/kg bw/day.
- Rationale for animal assignment (if not random): Body weight-balanced randomization.

Examinations
Parental animals: Observations and examinations
CAGE SIDE OBSERVATIONS: Yes- Time schedule: 3 times/day (before administration, immediately after administration and 1-3 hours after administration) during the administration period. Once a day during the recovery period.
DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule:
Males in the main groups and females in the non-mating groups: once before the start of admi
nistration, once every weekly during the administration.
Females in the mating groups: once before the start of administration, days specified during mating,gestation, and lactation (mated animals: gestation days 1, 7, 14 and 20, parturient animals: lactation
day 4)
Males and females in the recovery groups: once before the start of administration, once every weekly
during the administration and recovery periods.
BODY WEIGHT: Yes- Time schedule for examinations:
Males in the main groups and females in the non-mating groups: days 1, 8, 15, 22, 29, 36 and 42 of ad
ministration and on the day of necropsy
Males and females in the recovery groups: days 1, 8, 15, 22, 29, 36 and 42 of administration, and days
1, 8 and 14 of recovery and on the day of necropsy.
Females in the mating groups: days 1, 8 and 15 of administration, days 0, 7, 14, and 20 of gestation,days 0, 4 of lactation, and on 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 and females in the non-mating groups: days 1, 8, 15, 30, 36 and 42 of adm
inistration
Males and females in the recovery groups: days 1, 8, 15, 30, 36 and 42 of administration, and days 1, 8
and 14 of recovery
Females in the mating groups: days 1, 8 and 15 of administration, days 1, 7, 14, and 20 of gestation,days 2 and 4 of lactation
OPHTHALMOSCOPIC EXAMINATION: No
25

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: Isoflurane- Animals fasted: Yes- How many animals:
5 animals/sex/group- Parameters examined: red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mea
n 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.
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 checked: ALP, total cholesterol, triglyceride, phospholipids, total bilirubin, glucose, blood urea nitrogen, creatinine, sodium, potassium, chloride, calcium, inorganic phosphorus, total protein,
albumin, A/G ratio, AST (GOT), ALT (GPT), LDH, γ-GTP
URINALYSIS OF MALES: Yes- Time schedule for collection of urine: final week of administration (days 36 to 37 of administration)and in the final week of recovery (days 8 to 9 of recovery)- Metabolism cages used for collection of urine: Yes
A urine collector to collect four-hour urine samples under fasting but ad libitum drinking conditions,followed by collection of 20-hour urine samples under ad libitum feeding and drinking conditions.
- How many animals: 5 animals/group- Parameters checked: pH, protein, ketones, glucose, occult blood, bilirubin, urobilinogen, color, sediment, urine volume (4-hour volume), osmotic pressure, sodium, potassium, chloride, urine volume (20hour volume), water intake (24-hour volume)
BLOOD HORMONE: No
NEUROBEHAVIOURAL EXAMINATION: Yes- Time schedule for examinations:
Males in the main groups and females in the non-mating groups: final week of administration (day 41of administration)
Females in the mating groups: lactation day 4 (day 41 to day 43 of administration) after necropsy of
F1 pupsMales and females in the recovery groups: final week of administration (day 41 of administration) andin the final week of recovery (day 13 of recovery).
- Dose groups that were examined: All dose groups (5 animals/sex/group)- Battery of functions tested:
1) Manipulative Test. Auditory response, approach response, touch response, tail pinch response,
pupillary reflex, aerial righting reflex, landing foot splay
2) Measurement of Grip Strength. Following manipulative test, grip strength of forelimb and hind limb
were measured by CPU gauge MODEL-RX-5 (AIKOH Engineering Co., Ltd.).
3) Measurement of Motor Activity. Following measurement of grip strength, motor activity wasmeasured by a motor activity sensor for experimental animals NS-AS01 (Neuro Science, Inc.). The
measurement was conducted for 1 hour, and measured values at 10-minute intervals and from 0 to
60 minutes were collected.
Oestrous cyclicity (parental animals)
Vaginal smears were collected from all females in the mating groups and microscopically examined
every day from the day after the start of administration until the day copulation was confirmed.
26

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 all P male parental generations: testis weight, epididymis weight, histopatho
logical examinations for testes, epididymides, seminal vesicle and ventral prostate.
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, and weight gain.
GROSS EXAMINATION OF DEAD PUPS: Yes, for external and internal abnormalities.
Postmortem examinations (parental animals)
METHOD OF SACRIFICED: All animals were sacrificed by exsanguination under isoflurane anesthesia.
SACRIFICE: Males in main groups and females in non-mating groups: On next day after the last
administration (Day 43), Maternal animals: on Day 4 of lactation, and Male and females recovery anim
als: on Day 14 of recovery.
ORGAN WEIGHT: Yes [brain, pituitary, thyroids (including parathyroids), adrenal gland, thymus, spleen,
heart, liver, kidney, testis, epididymis, prostate, seminal vesicles, ovary, uterus]
HISTOPATHOLOGY: Yes, [cerebrum, cerebellum (including pons), sciatic nerve, spinal cord (thoracic),eye ball, optic nerve, Harderian gland, pituitary, thyroid, parathyroid, adrenal glands, thymus, spleen,submandibular lymph nodes, mesenteric lymph nodes, heart, thoracic aorta, trachea, lung (including
bronchial), tongue, larynx, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum,
submandibular gland, sublingual gland, liver, pancreas, kidney, bladder, testis, ovary, epididymis, uterus, vagina, prostate, seminal vesicles, skin (inguinal), mammary gland (inguinal), sternum and femur(including bone marrows), skeletal muscle of femur, and individual identification site (pinna with ear
tag)]
Postmortem examinations (offspring)
SACRIFICE- The F1 offsprings were euthanized on PND4 by exsanguination under isoflurane anesthesia.
GROSS NECROPSY：Yes- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, andabdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGTHS- Not examined.
Statistics
For quantitative data, homogeneity of variance was tested using Bartlett method first. If the variance
was homogenous, statistical difference between each treatment group and the control group was
analyzed using Dunnett method. If not homogenous, statistical difference between each treatmentgroup and the control group was tested using Steel method. For comparison of quantitative data be
tween two groups in the recovery test, homogeneity of variance was analyzed by F-test. Then, if homo
genous, student's t-test was applied. If not homogenous, Aspin-Welch's t-test was used.
Regarding clinical observation (except for frequency of urination, defecation, rearing and grooming)and sensory reactivity, Steel test was applied. Regarding implantation index, stillborn index, live birthindex, viability index and external abnormalities, Steel test was applied. Regarding copulation index,
insemination index, fertility index, and delivery index, auditory response, approach response, touch
response, tail pinch response, pupillary reflex, aerial righting reflex, Fisher's test was applied.
Reproductive indices
Each parameter was determined by the following equations:
Copulation index (%) = (No. of copulated animals / No. of mated animals) × 100
27

Fertility index (%) = (No. of pregnant females / No. of copulated females) × 100
Insemination index (%) = (No. of males which impregnated females / No. of copulated males) × 100
Gestation length (days) = No. of days from pregnancy day 0 to parturition day
Delivery index (%) = (No. of females which delivered liveborns / No. of pregnant females) × 100
Implantation index (%) = (No. of implantation sites / No. of corpora lutea) × 100
Stillborn index (%) = (No. of stillborn / No of liveborns and stillborns) × 100
Live birth index (%) = (No. of liveborn / No. of implantation sites) × 100
External abnormalities (%) = (No. of pups with external abnormalities / No. of liveborns) × 100
Sex ratio = No. of liveborns males / No. of liveborns
Sex ratio of live pups on day 4= No. of live males on day 4/ No. of live pups on day 4
Offspring viability indices
Viability index on postnatal day 4 (%) = (No. of live pups on day 4 / No. of liveborns on day 0) × 100

Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
Clinical signs
no effects observed
Mortality
no mortality observed
Body weight and weight changes
no effects observed
Food consumption and compound intake (if feeding study)no effects observed
Food efficiency
not examined
Water consumption and compound intake (if drinking water study)
not examined
Ophthalmological findings
not examined
Haematological findings
no effects observed
Clinical biochemistry findings
no effects observed
Urinalysis findings
no effects observed
Behaviour (functional findings)
no effects observed
Immunological findings
not examined
Organ weight findings including organ / body weight ratios
no effects observed28

Gross pathological findings
no effects observed
Neuropathological findings
not examined
Histopathological findings: non-neoplastic
no effects observed
Histopathological findings: neoplastic
not examined

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

Details on results (P0)General toxicity: See 7.5.1 Repeated dose toxicity.001
Reproductive function / performance: no effects observed.

Effect levels (P0)
Key result
true
Dose descriptor
NOAEL
Effect level1000

mg/kg bw/day (actual dose received)

Based ontest mat.
Sexmale/female
Key result
true
Dose descriptor
NOAEL
Effect level1000

mg/kg bw/day (actual dose received)

Based ontest mat.
29

Sex
male/female
Basis for effect level
reproductive performance
No reproductive effects were observed in both males and females up to 1000 mg/kg bw/day.

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

Details on results (F1)
No effects observed.

Effect levels (F1)
Key result
false
Dose descriptor
NOAEL
Generation
F1
Effect level1000

mg/kg bw/day (actual dose received)

Based ontest mat.
Sexmale/female
Basis for effect level
other:
There were no effects on developmental parameters up to 1000 mg/kg bw/day.

Overall reproductive toxicity
30

Key result
false
Reproductive effects observednoAny other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF627-83-8d.pdf

Applicant's summary and conclusion
Conclusions
In the combined repeated oral dose toxicity study with the reproduction/developmental toxicity
screening test (OECD TG 422) described above, there were no effects on the reproductive and dev
elopmental parameters up to 1000 mg/kg bw/day. The NOAEL for the rat reproductive/developmental
toxicity of 1,2-ethanediyl ester octadecanoic acid was regarded as 1000 mg/kg bw/day, the highest
dose tested.

31

DOMAIN
SUBSTANCE: 1,2-Ethanediyl ester octadecanoic acid
UUID: 7f7fd0af-2d67-4d26-80c1-6102ca1c431e
Dossier UUID:
Author:Date: 2022-03-25T11:11:57.000+09:00
Remarks:
Substance name
1,2-Ethanediyl ester octadecanoic acid
Legal entity
National Institute of Health Sciences / Kawasaki / Japan

Identification of substance
Reference substance
1,2-Ethanediyl ester octadecanoic acid / 627-83-8
EC number

EC name

CAS number

CAS name

627-83-8
IUPAC nameRole in the supply chain
Manufacturer
false
Importer
false
Only representativefalse
Downstream user
false

32

References
Reference Substances
REFERENCE_SUBSTANCE: 1,2-Ethanediyl ester
octadecanoic acid
UUID: e628f22e-848c-4dd6-802b-a13991de8ef8
Dossier UUID:
Author:Date: 2022-03-10T13:44:24.000+09:00
Remarks:
Reference substance name
1,2-Ethanediyl ester octadecanoic acidInventory
CAS number
627-83-8

Molecular and structural information
Molecular formula
C38H74O4
Molecular weight594.9933

Test Materials
TEST_MATERIAL_INFORMATION: 1,2-Ethanediyl ester
octadecanoic acid
UUID: 97be9601-509d-4cbc-880d-e76da4f04a9a
Dossier UUID:
Author:Date: 2022-03-10T13:23:12.000+09:00
Remarks:
Name
1,2-Ethanediyl ester octadecanoic acid34

Literatures
LITERATURE: Combined repeated dose toxicity study
with the reproductive/developmental toxicity screening
test of 1,2-ethanediyl ester octadecanoic acid by oral
administration in rats
UUID: 6747ce6c-b9cc-4ce2-bcdc-58ffba213f9a
Dossier UUID:
Author:Date: 2022-03-10T13:29:55.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Combined repeated dose toxicity study with the reproductive/developmental toxicity screening test of
1,2-ethanediyl ester octadecanoic acid by oral administration in rats
Author
Ministry of Health, Labour and Welfare (MHLW), Japan
Year
2013
Bibliographic source
available in the web of Japan Existing Chemical Data Base (JECDB) https://dra4.nihs.go.jp/
mhlw_data/home/pdf/PDF627-83-8d.pdf
Testing facility
BoZo Research Center
Report date2013-08-23
Report number
R-108935

LITERATURE: In Vitro Chromosomal Aberration Testof 1,2-Ethanediyl ester octadecanoic acid on Cultured
Chinese Hamster Cells.
UUID: b227c8e2-451b-4d7f-ac60-6d2204c7be47
Dossier UUID:
Author:Date: 2022-03-10T13:27:42.000+09:00
Remarks:

General information
Reference Typestudy report
Title
In Vitro Chromosomal Aberration Test of 1,2-Ethanediyl ester octadecanoic acid on Cultured Chinese
Hamster Cells.
Author
Ministry of Health, Labour and Welfare (MHLW), Japan
Year
2012
Bibliographic source
Japan Existing Chemical Data Base (JECDB) https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF62
7-83-8f.pdf
Testing facility
Bozo Research Center Inc.
Report date2012-03-23
Report number
T-G02436

LITERATURE: Reverse Mutation Test of 1,2-Ethanediyl
ester octadecanoic acid on Bacteria.
UUID: b0a5cd3f-57a8-4505-8907-9224f31b3971
Dossier UUID:
Author:Date: 2022-03-10T13:29:17.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Reverse Mutation Test of 1,2-Ethanediyl ester octadecanoic acid on Bacteria.
Author
Ministry of Health, Labour and Welfare (MHLW), Japan
Year
2012
Bibliographic source
Japan Existing Chemical Data Base (JECDB) https://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF62
7-83-8e.pdf
Testing facility
Bozo Research Center Inc.
Report date2012-03-22
Report number
T-088037