Name: COMPLETE / SUBSTANCE : 1,3-cyclohexanedimethanamine / 2579-20-6 Tue, 13 Dec
2022, 16:46:18+0900 /Legal entity owner: National Institute of Health Sciences
Printing date: 2022-12-13T16:46:20.272+09:00

iTable of Contents
0/0 ............................................................................................................................. 1
National Institute of Health Science ..................................................................... 2
1,3-cyclohexanedimethanamine ............................................................................ 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 ................................................ 2071 Genetic toxicity in vivo .......................................................... 24
Genetic toxicity in vivo.001 ................................................ 24
73 Toxicity to reproduction ........................................................ 29
Toxicity to reproduction.001 ............................................... 29
DOMAIN .................................................................................................... 36
Substance ......................................................................................... 36
Substance ................................................................................ 36
References ................................................................................................................ 37
Reference Substances ...................................................................................... 37
1,3-cyclohexanedimethanamine .................................................................. 37
Test Materials .................................................................................................. 392579-20-6 / 219-941-5 ............................................................................... 392579-20-6 / 219-941-5 ............................................................................... 40
2579-20-6 / 219-941-5 ............................................................................... 412579-20-6 / 219-941-5 ............................................................................... 422579-20-6 / 219-941-5 ............................................................................... 43
Literatures ....................................................................................................... 44
A combined repeated-dose/reproductive-developmental toxicity study of
1,3-Bis (aminomethyl) cyclohexane by oral administration in rats. ................. 44
In Vitro Chromosomal Aberration Test of 1,3-Bis (aminomethyl)
cyclohexane on Cultured Chinese Hamster Cells ......................................... 45
Micronucleus test of 1,3-Bis (aminomethyl) cyclohexane on mouse .............. 46
Reverse Mutation Test of 1,3-Bis (aminomethyl) cyclohexane on Bacteria. ..... 47
Single Dose Oral Toxicity Test of 1,3-Bis (aminomethyl) cyclohexane in
Rats .......................................................................................................... 48
Legal Entities ................................................................................................... 49
National Institute of Health Sciences .......................................................... 49ii

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1,3-cyclohexanedimethanamine / 2579-20-6
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National Institute of Health Science
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LEGAL_ENTITY: National Institute of Health
Science
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General information
Legal entity nameNational Institute of Health Science21,3-cyclohexanedimethanamine
CORE
General information
Assessment approach (assessment entities)
FIXED_RECORD: Assessment approach

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Author:Date: 2017-01-06T16:18:15.000+09:00
Remarks:3

OECD
Health Effects
Acute toxicity: oral
ENDPOINT_STUDY_RECORD: Acute toxicity: oral.001

UUID: IUC5-def78f2c-745c-45f4-9a6b-add50aad930e
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Author:Date: 2017-01-05T11:10:20.000+09:00
Remarks:

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

Data source
Reference
Single Dose Oral Toxicity Test of 1,3-Bis (aminomethyl) cyclohexane in Rats / MHW (Ministry of Healthand Welfare), Japan / study report
Data accessdata published

Materials and methods
Test guideline
Qualifieraccording to guideline
Guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)4

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

Test material
Test material information
2579-20-6 / 219-941-5

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: 8-9 weeks old- Weight at dosing: Females, 179 - 199 g (Third from first dosing)– Used animal number: A total of 16 females - Fasting period before study: Approximately 17 hrs- Housing: Three animal/cage- Diet (e.g. ad libitum): Ad libitum except fasting period for 17 hrs before
administration to 3 hrs after administration- Water (e.g. ad libitum): Ad libitum- Acclimation period: 5 days. ENVIRONMENTAL CONDITIONS- Temperature (°C): 21.0 – 22.6
- Humidity (%): 51.5 – 66.5
- Ventilation (per hr): Approximately 6 - 20 times- Photoperiod (hrs light / hrs dark): 12/12

Administration / exposure
Route of administration
oral: gavage
Vehiclewater
Details on oral exposure
VEHICLE- Concentration in vehicle: 30 and 200 mg/ml.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg b.w.
Doses
300 mg/kg bw (first and second administration)5

2000 mg/kg bw (third administration)
No. of animals per sex per doseFirst and second administration (first purchase): each 3 females (animal ID No. 50101 – 50103 and
60101 - 60103)
Third administration (second purchase): 3 females (animal ID No. 70101– 70103)
Control animals
noDetails on study design- Duration of observation period following administration: 14 days
- Frequency of observations: Before dosing, and 10 min, 30 min,1 h, 3h, and 6 h after dosing on the dayof dosing. Thereafter once a day.
- Frequency of weighing: Days 1 (before administration), 4, 8 and 15- Necropsy of survivors performed: Yes
StatisticsnoResults and discussion
Effect levels
Key result
false
Sex
female
Dose descriptor
LD50
Effect level
>

300

2000

mg/kg bw

Based onact. ingr.
Mortality
No deaths were observed in the first and second administration groups. Three animals receiving
2000 mg/kg died on the day or next day of dosing.
Clinical signs
other: No changes related to the test substance were observed at 300 mg/kg bw. Prone, supine, andcrouching positions, decrease in locomotor activity, irregular respiration, bradypnea, hypothermia, andpotosis were observed in the dead animals at 2000 mg/kg bw.
Gross pathology
No changes related to the test substance were observed at 300 mg/kg. Abnormal contents, edema,
and reddish change in the stomach, abnormal contents in the duodenum, jejunum, and ileum, and/or
ascites in the abdominal cavity were observed in the dead animals.

Applicant's summary and conclusion
6

Conclusions
The acute oral LD50 of 1,3-cyclohexanedimethanamine was >300–2000 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

UUID: IUC5-2c83f3d8-ebc6-474e-a65b-bdfd8e22d558
Dossier UUID:
Author:Date: 2022-12-13T16:43:55.704+09:00
Remarks:

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

Data source
Reference
A combined repeated-dose/reproductive-developmental toxicity study of 1,3-Bis (aminomethyl)
cyclohex / MHW (Ministry of Health and Welfare), Japan / study report
Data accessdata published8

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
2579-20-6 / 219-941-5

Test animals
Speciesratcommon rodent species
Strain
Crj: CD(SD)rat
Sexmale/female
Details on test animals or test system and environmental conditions
TEST ANIMALS- Source: Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation: 9 weeks of age- Weight at study initiation: 307-370 g for males and 197-239 g for females- Housing: bracket-type metallic wire-mesh cages (W 195 × D 235 × H 180 mm)- Diet (e.g. ad libitum):ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 21.6 to 22.4°C- Humidity (%): 52.9 to 64.9%- Air changes (per hr): 6 to 20 times per hour
- Photoperiod (hrs dark / hrs light):12-hour lighting per day

Administration / exposure
9Route of administration
oral: gavage
Vehiclewater
Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: Test substance was dissolved in olive oil for injection.
VEHICLE- Justification for use and choice of vehicle: No data
- Amount of vehicle (if gavage): 5 mL/kg bw- Lot/batch no. (if required): No data
- Dosing volume: 5 mL/kg- Stability (test solutions): For 8 days
- Storage condition of test solution: Stored in a refrigerator (2.8 – 8.4°C).
Analytical verification of doses or concentrations
yes
Details on analytical verification of doses or concentrations
Test suspensions at each concentration of initial and final preparations were analyzed by the GC met
hod at Mitsubishi Safety Institute Ltd. Results showed that the concentration of the test article in eachconcentration was 92.0 to 108.5% of the nominal concentration and both values were within theacceptable range (concentration: percentage of the nominal concentration, 100 ± 10%)Duration of treatment / exposure(P) Males: 42 days including 14 days pre-mating (P)Females: Days including 14 days pre-mating,mating and gestation periods and the days until day 4 of lactation Female (no mating, satellite group):
for 42 days
Frequency of treatment
Daily: 7 times / week
Doses / concentrations
Remarks
Doses / Concentrations:
0 (vehicle), 10, 60 and 300 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose
Main group:12 females/dose (0, 10, 60, and 300 mg/kg bw/day), 7, 12, 12, and 7 males/dose ( 0, 10, 60, and 300 mg/kg bw/day)Satellite group: 5 females/dose (0 and 300 mg/kg bw/day)Recovery group: 5 males/dose and 5 females (satellite group)/dose (0 and 300 mg/kg bw/day )Control animals
yes, concurrent vehicle
Details on study design- Dose selection rationale: A preliminary study was conducted to determine the doses to be employed.
Three males and three female SD rats were administrated 0, 30, 100, 300, and 1000 mg/kg bw/day ofthe substance for 14 days. As a result, death or dying was observed in all males and females receiving 1000 mg/kg bw/day. Edema of the forestomach was observed in all dead animals receiving 300
mg/kg bw/day. No changes attributable to the test substance were observed on both sexes receiving
10

30 and 100 mg/kg bw/day. Therefore, the high dose was set at 300 mg/kg bw/day, and the middle
and low dose were set at 60 and 10 mg/kg bw/day by using common ratio 5.
Positive controlnoExaminations
Observations and examinations performed and frequency
CAGE SIDE OBSERVATIONS: Yes- Time schedule:
Males and females: once before the start of administration, two times/day during the administration
period, and once during the recovery period
DETAILED CLINICAL OBSERVATIONS: Yes- Time schedule:
All animals; once before the start of administration, once every week until Week 6 of the administ
ration period.
BODY WEIGHT: Yes- Time schedule for examinations:
Males in the main and recovery groups were weighed on Day 1, 8, 15, 22, 29, 36, 42, and 43 ofadministration, and males of recovery groups were weighed on Day 50 and 56. Female satellitegroups were weighted same frequencies to male recovery groups. Females in the main groups were
weighed on Day 1, 8 and 15 of administration and copulated females were weighed on Day 0, 7, 14
and 20 of gestation, and days 0 and 4 of lactation.
FOOD CONSUMPTION : Yes- Food consumption (g/day/rat) for each animal determined from the difference of the of the previous
day's feeding amount: Yes
Measurement of food consumption was conducted on all animals at the following frequencies:
Males in the main and recovery groups; on Day 1-8, 8-15, 15-22, 22-29, 29-36, 36-38, 43-50, and 50-52.
Females in the satellite group; on Day 1-8, 8-15, 15-22, 22-29, 29-36, 36-42, 43-50, and 50-56. Females
in the main group; on Day 1, 8 and 15 of administration, on Day 0, 7, 14 and 20 of gestation, and on Day 0 and 4 of lactation.
FOOD INTAKE: No
HAEMATOLOGY: Yes- Time schedule for collection of blood: On Day 42 and 56 in males and satellite group females. On
Day 4 of the lactation period in main group females.
- Anaesthetic used for blood collection: Yes- 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 count, platelet
count, white blood cell count, differential white blood cell count, prothrombin time, activated partial
thromboplastin time
CLINICAL CHEMISTRY: Yes- Time schedule for collection of blood: On the next day of the final administration and on the final dayof the recovery period- Animals fasted: Yes- How many animals: 5 animals/sex/group- Parameters checked: ASAT (GOT), ALAT (GPT), γ-GT, ALP, total bilirubin, blood urea nitrogen, creat
inine, glucose, total cholesterol, triglyceride, total protein, albumin, A/G ratio, calcium, inorganic
phosphorus, sodium, potassium, chloride
URINALYSIS OF MALES: Yes- Time schedule for collection of urine (males only): Day 38 of administration- Metabolism cages used for collection of urine: Yes- Animals fasted: Yes- How many animals: 5 animals/males/group- Parameters checked: pH, protein, glucose, ketones, bilirubin, occult blood, urobilinogen
BLOOD HORMONE: No
11

NEUROBEHAVIOURAL EXAMINATION: Yes
Functional observation: Five males/dose at Week 6, and five females/dose during the lactation perio
d. No tests conducted during the recovery period because no changes were observed during theadministration period.
- Battery of functions tested:
1) Open field observation. Aerial righting reaction, arousal, urination, defecation, posture and body
position, breathing, co-ordination movement, gait, tremor, clonic convulsion, tonic convulsion, ster
eotypy, and bizarre behavior.
2) Manipulative Test. Approach response, touch response, auditory response, tail pinch response, andaerial righting reflex3) Measurement of Grip Strength. Following manipulative test, grip strength of forelimb and hind limb
was measured by Digital force gauge MODEL-DPS-5 (IMADA CO., LTD.).
4) Measurement of Motor Activity.Motor activity was measured by a motor activity sensor for expe
rimental animals SUPERMEX (Muromachi Kikai Co., Ltd.). The measurement was conducted for 1
hour, and measured values at 10-minute intervals and from 0 to 60 minutes was collected.
Sacrifice and pathology
GROSS PATHOLOGY AND ORGAN WEIGHTS：Yes, brain, heart, liver, kidneys, adrenals, thymus, spl
een, testes, and epididymis.
HISTOPATHOLOGY: Yes, cerebrum, puitality, thymus, lymph nodes (including mesenteric and man
dibular lymph nodes), trachea, lung, stomach, intestinal tract (duodenum, jejunum, ileum, cecum,colon, rectum), thyroids, parathyroid, heart, liver, spleen, kidneys, adrenals, urinary bladder, testes, epididymis, seminal vesicles (including the coagulating gland), prostate (ventral lobe), ovaries,
uterus, vagina, bone marrow (one side femur), Sciatic nerve (one side femur), spinal cord, and grossabnormalities site.
Statistics
Parametric data such as grip strength, motor activity, body weight and gain, food consumption, urine
volume, specific gravity, hematology, blood biochemistry, and absolute and relative organ weights w
ere analyzed by Bartlett’s test for homogeneity of distribution. When homogeneity was recognized,
one-way analysis of variance was performed. When a significant difference was observed, Dunnett’s
multiple comparison test was conducted for comparison between control and treated groups. If not
homogenous, analysis was performed using the Kruskal-Wallis ranking test. In consequence, if not
homogenous, Dunnett’s type mean rank sum test was conducted to compare to control and individual
treatment groups. Qualitative value as the pathological findings was analyzed by Wilcoxon test andFisher’s exact test. Urinalyses data were analyzed by Kruskal-Wallis and Dunnet’s type mean rank
test. Significance level was set at 0.05 compared with the control group and among the groups.

Results and discussion
Results of examinations
Clinical signs
effects observed, treatment-related
Mortality
mortality observed, treatment-related
Body weight and weight changes
effects observed, treatment-related
Food consumption and compound intake (if feeding study)no effects observed
Food efficiency
not examined
12

Haematological findings
effects observed, treatment-related
Clinical biochemistry findings
effects observed, treatment-related
Urinalysis findings
no effects observed
Behaviour (functional findings)
no effects observed
Organ weight findings including organ / body weight ratios
effects observed, treatment-related
Gross pathological findings
effects observed, treatment-related
Histopathological findings: non-neoplastic
effects observed, treatment-related
Details on results
CLINICAL SIGNS AND MORTALITY: Mortality: One male animal died in the 300 mg/kg bw/day grou
p.Clinical signs: Transient salivation was observed in all males and 16 females receiving 300 mg/kg
bw/day, sporadically.
DETAILED CLINICAL OBSERVATIONS, MANIPULATIVE TEST, GRIP STRENGTH TEST AND LOCO
MOTOR ACTIVITY MEASUREMENT: There were no changes related to the test substance in any groupduring the dosing.
BODY WEIGHT: Depression of body weight gains was observed in males receiving 300 mg/kg bw/day
on Day 8 to 42. This change was recovered by withdraw. No changes in body weights were observedin both sexes receiving 10 and 30 mg/kg bw/day compared with the control groups.
FOOD CONSUMPTION: There were no changes related to the test substance in any groups during thedosing and recovery periods.
URINALYSIS: There were no changes related to the test substance in any groups at the end of thedosing period.
HAEMATOLOGY: Increases in reticulocyte count and increase tendencies in white blood cell countwere observed in males receiving 300 mg/kg bw/day at end of the administration. No changes
were observed in females receiving 300 mg/kg bw/day at end of the dosing and recovery periods c
ompared with the control group.
CLINICAL CHEMISTRY: At the end of the dosing period, decreases in total protein level and increases
in ALAT activity were observed in males and females receiving 300 mg/kg bw/day, respectively. ALP
activity tended to increase at the end of the dosing period and significantly increased at the end of therecovery period in females at 300 mg/kg bw/day.
URINALYSES OF MALES: There were no changes related to the test substance.
ORGAN WEIGHTS: At the end of the dosing period, increases in absolute and relate adrenal weights
were observed in males receiving 300 mg/kg bw/day and increases in relative kidney and adrenal
weights were observed in females receiving 300 mg/kg bw/day. At the end of the recovery period, anincrease in relative adrenal weight was observed in males receiving 300 mg/kg bw/day. No changes
in absolute and relative organ weights were observed in both sexes receiving 10 and 60 mg/kg bw/
day compared with the control group.
GROSS PATHOLOGY: At the end of the dosing period, thickening forestomach wall was observed in all
males and females receiving 300 mg/kg bw/day and ulcer in the forestomach mucosa and adhesion
to the liver were observed in each female receiving 300 mg/kg bw/day. For the genital system, small
sized testes and epididymis were observed in two males receiving 300 mg/kg bw/day. These lesions were recovered at the end of the recovery period. Dark reddish changes in mucosa of the glandular
stomach, abnormal contents (tar) in the duodenum, jejunum, and ileum, and dilatation in the cecum and ileum were observed in dead animals receiving 300 mg/kg bw/day.
13

HISTOPATHOLOGY: NON-NEOPLASTIC:
Stomach: Focal hyperplasia of squamous, focal hyperkeratosis, ulcer and focal inflammatory cell infi
ltration were observed in the forestomach of all males and females receiving 300 mg/kg bw/day.
These lesions trended to recover at the end of the recovery period.
Testes: Atrophy of seminiferous tubule was observed in four males receiving 300 mg/kg bw/day andtwo males receiving 10 mg/kg bw/day. Diffuse hyperplasia of interstitial cell was observed in one male out of four males receiving 300 mg/kg bw/day. Atrophy of seminiferous tubule in the 10 mg/kg
bw/day group was slight, and this lesion was not observed in the 60 mg/kg bw/day group. Therefore,
this lesion was considered to be spontaneous. Atrophy of seminiferous tubule was observed in one
male receiving 300 mg/kg bw/day at the end of the recovery period.
Epididymis: Cell debris in duct in two males, decreases in sperm of duct in two males, and atrophy induct in one male were observed at 300 mg/kg bw/day.
In dead animals, there were focal hyperplasia of squamous and focal inflammatory cell infiltrationin the forestomach, hemorrhage in the glandular stomach, atrophy in the spleen and thymus, andcongestion and edema in the lungs.

Effect levels
Key result
false
Dose descriptor
NOAEL
Effect level60

mg/kg bw/day (actual dose received)

Based onact. ingr.
Sexmale/female
Basis for effect level
other: see 'Remark'One male died in the 300 mg/kg bw/day group. At this dose, salivation was observed in both sexes,
and decreased body weight gain was observed in males. The relative and absolute weights of theadrenal gland in males and relative weights of the kidneys and adrenal gland in females increasedin the 300 mg/kg bw/day groups. Upon histopathological examination, inflammatory cell infiltration,
focal hyperkeratosis, focal squamous cell hyperplasia, and ulceration in the forestomach in both
sexes, and atrophy of seminiferous tubules of the testis in males were observed at 300 mg/kg bw/
day.

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

Any other information on results incl. tables
14

Figures and Tables (in English) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF2579-20-6d.pdf

Applicant's summary and conclusion
Conclusions
Based on the decreased body weight gain and histopathological changes in the forestomach, the
NOAEL for the male and female rat repeated dose toxicity of 1,3-cyclohexanedimethanamine was determined to be 60 mg/kg bw/day.

15

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

UUID: IUC5-cacf676c-1e5b-4a70-a9b9-477ceacbff28
Dossier UUID:
Author:Date: 2019-09-03T11:45:31.000+09:00
Remarks:

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

Data source
Reference
Reverse Mutation Test of 1,3-Bis (aminomethyl) cyclohexane on Bacteria. / MHW (Ministry of Healthand Welfare), 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

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

Test material
Test material information
2579-20-6 / 219-941-5

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 pKM 101
bacteria
Metabolic activation
with and without
Metabolic activation system
S9 mix; SD male rat liver, induced by phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose
-S9 mix: 39.1, 78.1, 156, 313, 625, 1250 μg/plate (TA100, TA 98, TA 1537, TA1535 strains),
156, 313, 625, 1250, 2500, 5000 μg/plate (P2uvrA/pKM101 strains)+S9 mix: 39.1, 78.1, 156, 313, 1250 μg/plate (TA100, TA98, TA1537 strains), 9.77, 19.5, 39.1, 78.1, 156, 313, 625, 1250 μg/plate (TA 1535)
39.1, 78.1, 156, 313, 625, 1250 μg/plate (WP2uvrA/pKM101 strain)
Vehicle / solvent- Vehicle(s)/solvent(s) used: Distilled water
Controls
Untreated negative controlsno17

Negative solvent / vehicle controls
yes
True negative controlsnoPositive controls
yes
Positive control substanceother:
Remarks-S9 mix: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide (TA 100, TA98 and WP2 uvrA/pKM101), sodium
azide (TA1535) and 9-aminoacridine hydrochloride (TA1537). +S9 mix: 2-aminoanthracene (all str
ains)
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 and reproducible increase was observed.
StatisticsnoResults and discussion
Test results
Key result
false
Species / strain
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity
Vehicle controls validity
valid
Positive controls validity
valid

18

Key result
false
Species / strain
E. coli WP2 uvr A pKM 101
bacteria
Metabolic activation
with and without
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity
Vehicle controls validity
valid
Positive controls validity
validRemarks on result
other: all strains/cell types tested Migrated from field 'Test system'.

Any other information on results incl. tables
Figures and Tables (in Japanese) are available in the following full report of the study. http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF2579-20-6e.pdf
Tables (in English) are attachted to this document. Please download the export file to see the Tables.

Applicant's summary and conclusion
Conclusions
Interpretation of results (migrated information):negative
In a bacterial reverse mutation assay using Salmonella typhimurium TA100, TA1535, TA98, andTA1537, and Escherichia coli WP2uvrA/pKM101 (OECD TG 471), 1,3-cyclohexanedimethanamine wasnegative with or without metabolic activation.

19

ENDPOINT_STUDY_RECORD: Genetic toxicity in vitro.002

UUID: IUC5-8e0b8c68-92bf-413e-a1a0-975e363142bb
Dossier UUID:
Author:Date: 2022-12-13T16:41:07.940+09:00
Remarks:

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

Data source
Reference
In Vitro Chromosomal Aberration Test of 1,3-Bis (aminomethyl) cyclohexane on Cultured Chinese
Hamste / MHW (Ministry of Health 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
20

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

Test material
Test material information
2579-20-6 / 219-941-5

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
Test concentrations with justification for top dose
Cell growth inhibition study-S9 mix: 125, 250, 500, 750, 1000, 1250, 1500 ug/mL (IC50=297 ug/mL)+S9 mix: 125, 250, 500, 750, 1000, 1250, 1500 ug/mL (IC50=353 ug/mL)
continuous treatment 1:12.5, 25, 50, 75, 100, 125, 150, 200 ug/mL
continuous treatment 2: 100, 150, 200, 250, 300, 350, 400, 450, 500 ug/mL (IC50=320 ug/mL)
Main study-S9: 200, 250, 300, 350, 400, 450, 500 ug/mL+S9: 250, 300, 350, 400, 500 ug/mL

Vehicle / solvent- Vehicle(s)/solvent(s) used: Saline
Controls
Untreated negative controlsno21

Negative solvent / vehicle controls
yes
True negative controlsnoPositive controls
yes
Positive control substanceother:
Remarks[-S9]: mitomycin C; [+S9]: Benzo[a]pyrene
Details on test system and experimental conditions
METHOD OF APPLICATION: Exposure duration: [short-term treatment]:6 hrs + 18 hr
SPINDLE INHIBITOR: Colcemid
STAIN: Giemsa stain for 20 min.
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 500 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(-): lessthan 5%, Equivocal(±): 5% or more and less than 10%, Positive(+): 10% or more
StatisticsnoResults and discussion
Test results
Key result
false
Species / strainother: Chinese hamster lung (CHL/IU) cells
Metabolic activation
without
Genotoxicity
positive
Cytotoxicity / choice of top concentrations
cytotoxicity
Vehicle controls validity
valid
Positive controls validity
valid
Key result
false
22

Species / strainother: Chinese hamster lung (CHL/IU) cells
Metabolic activation
with
Genotoxicity
negative
Cytotoxicity / choice of top concentrations
cytotoxicity
Vehicle controls validity
valid
Positive controls validity
valid
Additional information on results
Figures and Tables (in Japanese) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF2579-20-6f.pdf
Tables (in English) are attachted to this document. Please download the export file to see the Tables.
Remarks on result
other: all strains/cell types tested Migrated from field 'Test system'.

Applicant's summary and conclusion
Conclusions
Interpretation of results (migrated information):
positive without metabolic activation
negative with metabolic activation
The in vitro chromosomal aberration test using CHL/IU cells (OECD TG 473) was positive without metabolic activation.

23

Genetic toxicity in vivo
ENDPOINT_STUDY_RECORD: Genetic toxicity in vivo.001

UUID: IUC5-0e5723ed-e003-4aba-a6dc-8f7e0401ba4a
Dossier UUID:
Author:Date: 2017-01-10T11:56:31.000+09:00
Remarks:

Administrative data
Endpoint
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus Type of genotoxicity:
chromosome aberration
Type of information
experimental study
Adequacy of study
other information
Robust study summary
false
Used for classification
false
Used for SDS
false
Study period
11/10/2009-3/26/2010
Reliability
1 (reliable without restriction)
Rationale for reliability incl. deficiencies
other: GLP guideline study

Data source
Reference
Micronucleus test of 1,3-Bis (aminomethyl) cyclohexane on mouse / MHLW / study report
Data accessdata published

Materials and methods
Test guideline
Qualifieraccording to guideline
24Guideline
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Deviations
no
Qualifieraccording to guideline
Guideline
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviationsno
GLP complianceyes (incl. QA statement)
Type of assay
micronucleus assay
chromosome aberration

Test material
Test material information
2579-20-6 / 219-941-5

Test animals
Speciesmouse
Strainother: Crlj:CD1(ICR)
Sexmale
Details on test animals or test system and environmental conditions
TEST ANIMALS- ICR, [CD1 (ICR), SPF- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 9 weeks- Weight at study initiation: range finding study, males: 32.5-37.4 g, females: 23.7-29.5 g: main study:
males: 31.3-37.8 g- Assigned to test groups randomly: yes- Housing: bracket type TPX resin cage, (143W×293D×148Hmm)- Diet: ad libitum- Water: ad libitum- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 22.5-24.0- Humidity (%): 49.0-69.0- Air changes (per hr): 10-15/h- Photoperiod : 12 h dark/12 h light (light time: 7:00 AM to 7:00 PM)
25

Administration / exposure
Route of administration
oral: gavage
Vehicle- Vehicle(s)/solvent(s) used: Water for Injection- Concentration of test material in vehicle: 12.5, 25, and 50 mg/mL- Amount of vehicle: 10 mL/kg bw
Details on exposure
PREPARATION OF DOSING SOLUTIONS: It was administered within three days after the preparation
Duration of treatment / exposure
2 dyasFrequency of treatment
Twice, 24 h interval
Post exposure period
24 hDoses / concentrations
Remarks
Doses / Concentrations:
125, 250, and 500 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose
5 males/doseControl animals
yes, concurrent vehicle
Positive control(s)Cyclophosphamide monohydrate (CP)- Route of administration: oral gavage- Doses / concentrations: 50 mg/kg bw/day, single dose

Examinations
Tissues and cell types examined
polychromatic erythrocytes from the femur bone marrow
Details of tissue and slide preparation
TREATMENT AND SAMPLING TIMES: Cells for specimen were collected 24 h after the last admini
stration.
DETAILS OF SLIDE PREPARATION: Cell suspensions were spread on a slide glass, dried, and fixedwith methanol for five min. Each specimen was stained with acridine orange.
METHOD OF ANALYSIS: fluorescence microscopy, blind method.

26

Evaluation criteria
The test substance was determined to be positive if the micronucleated cells were statistically incr
eased in the dosing groups compared with the negative control group
Statistics
Appearance frequency of micronuclei: Fisher’s test (one-sided test) was conducted between thenegative or positive control and treatment groups. The Bonferroni correction was used for consid
eration of multiplicity. Significant level was set as 5 and 1% levels. Trend test of Chochran-Armitage(one-sided test) was used for frequency of micronuclei appearance.
Polychromatic erythrocytes in erythrocytes: These rates were analyzed using Bartlett’s test for homogeneity of distribution excluding positive control, and homogeneity was observed. Difference
between negative control group and each treatment groups was analysed by Dunnett’s multiple com
parison test (two-sided test). Difference between negative and positive controls was analyses by F-t
est and Student’s t-test. Significant levels were set as 5% for Bartlett’s test and F-test, and as 1 and 5%
for Dunnett’s test and Student t-test.

Results and discussion
Test results
Key result
false
Sex
male
Genotoxicity
negative
Toxicity
yes Decrease in locomotor activity and piloerection were observed at 500 mg/kg bw/day
Vehicle controls validity
valid
Negative controls validity
not examined
Positive controls validity
valid
Additional information on results
RESULTS OF RANGE-FINDING STUDY- Dose range: 0, 250, 500, 1000, and 2000 mg/kg bw/day (two times)- Clinical signs of toxicity in test animals: Decreases in locomotor activity and piloerection with sa
livation were observed in all males and one male receiving 500 mg/kg bw/day, respectively. Decreases in locomotor activity, piloerection, lacrimation, staggering gait, subnormal temperature, prone position, and death (all males and one female) were observed in 1000 mg/kg bw/day groups. Decreases
in locomotor activity, prone position, and decrease in respiration, death, and moribund condition wereobserved in 2000 mg/kg bw/day groups.
RESULTS OF DEFINITIVE STUDY- Induction of micronuclei: appearance frequency of micronucleated cells (%MNPCE) for dose levels, 0,125, 250, and 500 mg/kg bw/day were 0.13%, 0.10%, 0.05%, and 0.08%, respectively.
- Frequency of PCEs for dose levels, 0,125, 250, and 500 mg/kg bw/day were 54.5%, 59.6%, 55.7%, and51.2%, respectively.
- Body weight: not examined- Statistical evaluation: yes
27

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/PDF2579-20-6g.pdf

Applicant's summary and conclusion
Conclusions
Interpretation of results (migrated information): negative
The test substance did not increase the frequency of micronucleated polychromatic erythrocytes or
induce chromosomal aberrations in vivo.

28

Toxicity to reproduction
ENDPOINT_STUDY_RECORD: Toxicity to reproduction.001

UUID: IUC5-f5198f4a-19fa-4670-81e6-7283a5ca8d96
Dossier UUID:
Author:Date: 2022-12-13T16:45:02.239+09:00
Remarks:

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

Data source
Reference
A combined repeated-dose/reproductive-developmental toxicity study of 1,3-Bis (aminomethyl)
cyclohex / MHW (Ministry of Health and Welfare), Japan / study report
Data accessdata published

Materials and methods
29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
2579-20-6 / 219-941-5

Test animals
Speciesrat
Strainother: Crj: CD(SD), SPF
Sexmale/female
Details on test animals or test system and environmental conditions
TEST ANIMALS- Source: Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation: 9 weeks of age- Weight at study initiation: 307-370 g for males and 197-239 g for females- Housing: bracket-type metallic wire-mesh cages (W 195 × D 235 × H 180 mm)- Diet (e.g. ad libitum):ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 21.6 to 22.4°C- Humidity (%): 52.9 to 64.9%- Air changes (per hr): 6 to 20 times per hour
- Photoperiod (hrs dark / hrs light):12-hour lighting per day

Administration / exposure
Route of administration
oral: gavage
Vehiclewater
30

Details on mating procedure- M/F ratio per cage: 1/1- Length of cohabitation: up to 2 weeks- 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
Test suspensions at each concentration of initial and final preparations were analyzed by the GC met
hod at Mitsubishi Safety Institute Ltd. Results showed that the concentration of the test article in eachconcentration was 92.0 to 108.5% of the nominal concentration and both values were within theacceptable range (concentration: percentage of the nominal concentration, 100 ± 10%)Duration of treatment / exposure(P) Males: 42 days including 14 days pre-mating, mating, and thereafter 14 periods (subsequent 28 days)(P) Females: Days including 14 days pre-mating, mating and gestation periods and the days until day
4 of lactation
Frequency of treatment
Daily: 7 times / week
Doses / concentrations
Remarks
Doses / Concentrations:
0 (vehicle), 10, 60 and 300 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose
12 females/dose (0, 10, 60, 300 mg/kg bw/day), 7, 12, 12, and 7 males of 0, 10, 60, and 300 mg/kg bw/day, respectively, 5 males (recovery group) and 5 females (satellite group) at 0 and at 0 and 300 mg/
kg bw/dayControl animals
yes, concurrent vehicle

Examinations
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.
Mean estrous cycle (day) and abnormal estrous cycle animals (not 4 to 6 day in estrous cycle) were
examined by dams.
Sperm parameters (parental animals)
Parameters examined in P male parental generations: testes weight, epididymides weight
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.
Postmortem examinations (parental animals)
METHOD OF SACRIFICED: All animals were sacrificed by exsanguination under pentobarbital sodium
anesthesia, intraperitoneally.
31

SACRIFICE: Male animals: On Day 42, Maternal animals: on Day 4 of lactation, and Male recovery andfemale satellite animals: on Day 56.
GROSS PATHOLOGY AND ORGAN WEIGHTS：Yes Brain, heart, liver, kidneys, adrenals, thymus, sp
leen, testes, and epididymis.
HISTOPATHOLOGY: Yes Cerebrum, puitality, thymus, lymph nodes (including mesenteric and man
dibular lymph nodes), trachea, lung, stomach, intestinal tract (duodenum, jejunum, ileum, cecum,colon, rectum), thyroids, parathyroid, heart, liver, spleen, kidneys, adrenals, urinary bladder, testes, epididymis, seminal vesicles (including the coagulating gland), prostate (ventral lobe), ovaries,
uterus, vagina, bone marrow (one side femur), Sciatic nerve (one side femur), spinal cord, and grossabnormalities site.
Postmortem examinations (offspring)
SACRIFICE: The F1 pups were euthanized on PND 4 by exsanguination pentobarbital sodium ane
sthesia, intraperitoneally.
GROSS NECROPSY: Yes
Statistics
Parametric data such as grip strength, motor activity, body weight and gain, food consumption, urine
volume, specific gravity, hematology, blood biochemistry, and absolute and relative organ weights w
ere analyzed by Bartlett’s test for homogeneity of distribution. When homogeneity was recognized,
one-way analysis of variance was performed. When a significant difference was observed, Dunnett’s
multiple comparison test was conducted for comparison between control and treated groups. If not
homogenous, analysis was performed using the Kruskal-Wallis ranking test. In consequence, if not
homogenous, Dunnett’s type mean rank sum test was conducted to compare to control and individual
treatment groups. Qualitative value as the pathological findings was analyzed by Wilcoxon test andFisher’s exact test. Urinalyses data were analyzed by Kruskal-Wallis and Dunnet’s type mean rank
test. Significance level was set at 0.05 compared with the control group and among the groups.
Reproductive indices
1) Each parameter was determined by the following equations:
Mean estrus cycle, incidence of females with irregular estrus cycle, mating periods,
Copulation index (%) = (No. of copulated animals/No. of co-housed animals) × 100
Fertility index (%) = (No. of pregnant females/No. of copulated females) × 100
Gestation length, number of corpora lutea, number of implantation sites, total number of offspring,
Implantation index (%) = (No. of implantation sites/No. of corpora lutea) × 100
Delivery index (%) = (No. of females delivered liveborn pups/No. of pregnant females) × 100
Gestation index (%) = (No. of pregnant animals delivered live offspring/number of pregnant animals) ×100
Offspring viability indicesTotal number of offspring at birth, number of live offspring at birth,
Number of live pups on day 0 of lactationBirth index (%) = (Number of live pups on day 0/Number of
implantation sites) ×100
Viability index = (Number of live pups on day 4 after birth/Number of live pups born) ×100
External examination of offspring, necropsy finding
Pups weight on day 0 of lactation
Sex ratio on day 0 of lactation
Number of live pups on day 4 of lactation
Pups weight on day 4 of lactation
Sex ratio on day 4 of lactation

Results and discussion
Results: P0 (first parental generation)
32

General toxicity (P0)
Clinical signs
effects observed, treatment-related
Description (incidence and severity)see 7.5.1
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
Other effects
no effects observed

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

Details on results (P0)1) Estrous Cycle
There were no animals showing abnormal estrous cycles, and there were no significant differences in
the average length of the estrous cycle between the control group and any treatment group.
2) Results of Mating
There were no significant differences in the incidence of females with irregular estrus cycle, mating
period with the number of estrus and day of conceiving, copulation index, and fertility index between
the control group and any treatment groups.
3) Delivery Data and Delivery
There were no significant differences in the gestation length, number of corpora lutea, number of impl
antation sites, implantation index, and delivery index between the control group and any treatment g
roups.
GROSS PATHOLOGY
See 7.5.1 Repeated dose toxicity: oral
HISTOPATHOLOGY
See 7.5.1 Repeated dose toxicity: oral

Effect levels (P0)
Key result
false
Dose descriptor
NOAEL
33

Effect level300

mg/kg bw/day (actual dose received)

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

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

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

mg/kg bw/day (actual dose received)

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

Overall reproductive toxicity
34

Key result
false
Reproductive effects observed
not specified

Any other information on results incl. tables
Figures and Tables (in English) are available in the following full report of the study.
http://dra4.nihs.go.jp/mhlw_data/home/pdf/PDF2579-20-6d.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 reproductive and developmental
parameters at 300 mg/kg bw/day. The NOAEL for the rat reproductive/developmental toxicity of 1,3cyclohexanedimethanamine was regarded as 300 mg/kg bw/day, the highest dose tested.

35

DOMAIN
Substance
SUBSTANCE: 1,3-cyclohexanedimethanamine
UUID: IUC5-851687c2-464b-449c-86f2-ad7eb2a7b895
Dossier UUID:
Author:Date: 2022-12-13T16:45:43.250+09:00
Remarks:
Substance name
1,3-cyclohexanedimethanamine
Legal entity
National Institute of Health Sciences / Kawasaki / Japan

Identification of substance
Reference substance
1,3-cyclohexanedimethanamine / 2579-20-6 / 219-941-5
EC number

EC name219-941-5

EC Inventory

CAS number

CAS name2579-20-6

1,3-cyclohexanedimethanamine

IUPAC nameRole in the supply chain
Manufacturer
false
Importer
false
Only representativefalse
Downstream user
false

36

References
Reference Substances
REFERENCE_SUBSTANCE: 1,3cyclohexanedimethanamine
UUID: IUC5-c6161afa-424f-4a3a-9f14-f5aab542828b
Dossier UUID:
Author:Date: 2022-12-13T16:31:35.992+09:00
Remarks:
Reference substance name
1,3-cyclohexanedimethanamine

Inventory
Inventory number
Inventory name
1,3-Cyclohexanedimethanamine
Inventory
EC Inventory
Inventory number
219-941-5
CAS number
2579-20-6
Molecular formula
C8H18N2
Description
CAS number
2579-20-6
CAS name
1,3-cyclohexanedimethanamine

Synonyms
Synonyms
Identity
1,3-Bis(aminomethyl)cyclohexane

Molecular and structural information
37

Molecular formula
C8H18N2

38

Test Materials
TEST_MATERIAL_INFORMATION: 2579-20-6 / 219-941-5
UUID: e8451f0b-499f-3741-bd73-3b0d233b4969
Dossier UUID:
Author:Date: 2017-01-10T11:56:31.000+09:00
Remarks:
Name
2579-20-6 / 219-941-5

Composition
Composition
Type
Constituent
Reference substance
1,3-cyclohexanedimethanamine / 2579-20-6 / 219-941-5
EC number

EC name219-941-5

EC Inventory

CAS number

CAS name2579-20-6

1,3-cyclohexanedimethanamine

IUPAC name

Other characteristics
Details on test material- Name of test material (as cited in study report): 1,3-Bis (aminomethyl) cyclohexane or 1,3-Cyclohe
xanedimethanmine- CAS No.: 2579-20-6- Molecular formula: C8H18N2- Lot No.: CDH5467- Purity: 100.1%- Supplier: Wako Pure Chemical Industries, Ltd..
- Physical state: Colorless liquid- Storage condition of test material: Stored in a refrigerator

39

TEST_MATERIAL_INFORMATION: 2579-20-6 / 219-941-5
UUID: 3cf05eca-a8ef-3c79-b1d4-a65400828533
Dossier UUID:
Author:Date: 2017-01-06T16:17:10.000+09:00
Remarks:
Name
2579-20-6 / 219-941-5

Composition
Composition
Type
Constituent
Reference substance
1,3-cyclohexanedimethanamine / 2579-20-6 / 219-941-5
EC number

EC name219-941-5

EC Inventory

CAS number

CAS name2579-20-6

1,3-cyclohexanedimethanamine

IUPAC name

Other characteristics
Details on test material- Name of test material (as cited in study report): 1,3-Bis (aminomethyl) cyclohexane or 1,3-Cyclohe
xanedimethanmine- CAS No.: 2579-20-6- Lot No.: 50303- Purity: 99.98%- Supplier: MITSUBISHI GAS CHEMICAL COMPANY, INC.
- Boiling point : 244°C- Melting point/Freezing point: <-70°C- Flash point: 113°C- Specific gravity: 0.940-0.950 (120°C)- Vapor pressure: 1866 Pa, 14 mmHg (120°C)- Solubility: Soluble in water, alcohol, n-hexane et al.
- Odor: Amine odor
- Physical state: Colorless liquid- Storage condition of test material: stored in a refrigerator

40

TEST_MATERIAL_INFORMATION: 2579-20-6 / 219-941-5
UUID: ee9eafa9-55bf-32ff-a298-e32c81563440
Dossier UUID:
Author:Date: 2017-01-05T11:10:20.000+09:00
Remarks:
Name
2579-20-6 / 219-941-5

Composition
Composition
Type
Constituent
Reference substance
1,3-cyclohexanedimethanamine / 2579-20-6 / 219-941-5
EC number

EC name219-941-5

EC Inventory

CAS number

CAS name2579-20-6

1,3-cyclohexanedimethanamine

IUPAC name

Other characteristics
Details on test material- Name of test material (as cited in study report): 1,3-Bis (aminomethyl) cyclohexane or 1,3-Cyclohe
xanedimethanmine- CAS No.: 2579-20-6- Lot No.: 50303- Purity: 99.98%- Supplier: MITSUBISHI GAS CHEMICAL COMPANY, INC.
- Boiling point : 244°C- Melting point/Freezing point: <-70°C- Flash point: 113°C- Specific gravity: 0.940-0.950 (20°C)- Solubility: Soluble in water, alcohol, n-hexane et al.
- Odor: Amine odor
- Physical state: Colorless liquid- Storage condition of test material: in a refrigerator with nitrogen gas replacement

41

TEST_MATERIAL_INFORMATION: 2579-20-6 / 219-941-5
UUID: 1edf6b5f-321a-3630-aa97-6515a1fa6206
Dossier UUID:
Author:Date: 2017-01-06T11:59:01.000+09:00
Remarks:
Name
2579-20-6 / 219-941-5

Composition
Composition
Type
Constituent
Reference substance
1,3-cyclohexanedimethanamine / 2579-20-6 / 219-941-5
EC number

EC name219-941-5

EC Inventory

CAS number

CAS name2579-20-6

1,3-cyclohexanedimethanamine

IUPAC name

Other characteristics
Details on test material- Name of test material (as cited in study report): 1,3-Bis (aminomethyl) cyclohexane or 1,3-Cyclohe
xanedimethanmine- CAS No.: 2579-20-6- Lot No.: 50303- Purity: 99.98%- Supplier: MITSUBISHI GAS CHEMICAL COMPANY, INC.
- Boiling point : 244°C- Melting point/Freezing point: <-70°C- Flash point: 113°C- Specific gravity: 0.940-0.950 (20°C)- Solubility: Soluble in water, alcohol, and n-hexane.
- Odor: Amine odor
- Physical state: Colorless liquid- Storage condition of test material: Stored in a refrigerator (2.8 – 8.4°C).

42

TEST_MATERIAL_INFORMATION: 2579-20-6 / 219-941-5
UUID: a9d37dae-c813-3e10-a23b-96eb4f47595a
Dossier UUID:
Author:Date: 2017-01-10T12:21:07.000+09:00
Remarks:
Name
2579-20-6 / 219-941-5

Composition
Composition
Type
Constituent
Reference substance
1,3-cyclohexanedimethanamine / 2579-20-6 / 219-941-5
EC number

EC name219-941-5

EC Inventory

CAS number

CAS name2579-20-6

1,3-cyclohexanedimethanamine

IUPAC name

Other characteristics
Details on test material- Name of test material (as cited in study report): 1,3-Bis (aminomethyl) cyclohexane or 1,3-Cyclohe
xanedimethanmine
See 7.5.1 Repeated dose toxicity: oral Endpoint study record: Repeated dose toxicity: oral.001 for fur
ther information

43

Literatures
LITERATURE: A combined repeated-dose/reproductivedevelopmental toxicity study of 1,3-Bis (aminomethyl)
cyclohexane by oral administration in rats.
UUID: 9c85df8c-a37d-33d0-90d8-cce94ed30246
Dossier UUID:
Author:Date: 2017-01-06T11:59:01.000+09:00
Remarks:

General information
Reference Typestudy report
Title
A combined repeated-dose/reproductive-developmental toxicity study of 1,3-Bis (aminomethyl)
cyclohexane by oral administration in rats.
AuthorMHW (Ministry of Health and Welfare), Japan
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Mitsubishi Safety Institute Ltd.
Study number
B041798

44

LITERATURE: In Vitro Chromosomal Aberration Test of
1,3-Bis (aminomethyl) cyclohexane on Cultured Chinese
Hamster Cells
UUID: c80664bd-5492-3747-ad3c-992a01f8196d
Dossier UUID:
Author:Date: 2017-01-06T16:17:10.000+09:00
Remarks:

General information
Reference Typestudy report
Title
In Vitro Chromosomal Aberration Test of 1,3-Bis (aminomethyl) cyclohexane on Cultured Chinese
Hamster Cells
AuthorMHW (Ministry of Health and Welfare), Japan
Year
2006
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Mitsubishi Safety Institute Ltd.
Report date
2006-09-15
Study number
B041800

45

LITERATURE: Micronucleus test of 1,3-Bis (aminomethyl)
cyclohexane on mouse
UUID: 35b125e8-c778-35b0-8540-5fef7fa7633c
Dossier UUID:
Author:Date: 2017-01-10T11:56:31.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Micronucleus test of 1,3-Bis (aminomethyl) cyclohexane on mouse
Author
MHLW
Year
2010
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Food and Drug Safety Center
Report date2010-03-30
Study number
G-09-02-023

46

LITERATURE: Reverse Mutation Test of 1,3-Bis(aminomethyl) cyclohexane on Bacteria.
UUID: cd1215ac-345f-345f-a6ba-51ce0ed44575
Dossier UUID:
Author:Date: 2017-01-06T15:59:51.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Reverse Mutation Test of 1,3-Bis (aminomethyl) cyclohexane on Bacteria.
AuthorMHW (Ministry of Health and Welfare), Japan
Year
2006
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Mitsubishi Safety Institute Ltd.
Report date
2006-09-14
Report number
B041799

47

LITERATURE: Single Dose Oral Toxicity Test of 1,3-Bis(aminomethyl) cyclohexane in RatsUUID: fd4818f3-11a2-3e3f-980d-1fc3fd5c56da
Dossier UUID:
Author:Date: 2017-01-05T11:10:20.000+09:00
Remarks:

General information
Reference Typestudy report
Title
Single Dose Oral Toxicity Test of 1,3-Bis (aminomethyl) cyclohexane in Rats
AuthorMHW (Ministry of Health and Welfare), Japan
Year
2007
Bibliographic source
Japan Existing Chemical Data Base (JECDB)
Testing facility
Mitsubishi Safety Institute Ltd.
Study number
B04179748

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

Identifiers
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IT system
LEO
ID
10767
IT systemIUCLID449

ID
16558402024DIV750

50