“GHS Mixture Classification and Labels/SDS
Creation System (NITE-Gmiccs)”

Classification Logic
Ver.2.4

Contents
1．Introduction ........................................................................................................................................................1
Principle of classification .....................................................................................................................................1
Effects on Aquatic Environment Decision ..........................................................................................................4
Multiple hazards and precedence of hazard information ..................................................................................5
2．Physical Hazards Guidance ...............................................................................................................................6
2.4.1 Relationship between UNRTDG classification and GHS Categorization ...............................................7
2.5.2 Flammable Gases ......................................................................................................................................10
2.5.4 Oxidizing Gases .........................................................................................................................................122.5.6 Flammable Liquids ...................................................................................................................................13
Notes at the classification of physical hazards ................................................................................................14
3. Health Hazards Guidance (mixture) ................................................................................................................15
3.5.1 Acute Toxicity.............................................................................................................................................15
3.5.2 Skin Corrosion/Irritation ..........................................................................................................................19
3.5.3 Serious Eye Damage/Eye Irritation .........................................................................................................21
3.5.4 Respiratory or Skin Sensitization ............................................................................................................24
3.5.5 Germ Cell Mutagenicity............................................................................................................................26
3.5.6 Carcinogenicity ..........................................................................................................................................27
3.5.7 Reproductive Toxicity ................................................................................................................................28
3.5.8 Specific Target Organ Toxicity-Single Exposure.....................................................................................30
3.5.9 Specific Target Organ Toxicity-Repeated Exposure ...............................................................................32
3.5.10 Aspiration Hazard ...................................................................................................................................33
4. Environmental Hazards Guidance ...................................................................................................................34
4.4.1 Hazardous to the Aquatic Environment – Acute Hazard .......................................................................34
4-4-2 Hazardous to the ozone layer ...................................................................................................................40

NITE-Gmiccs Classification Logic
1．Introduction
The "GHS Mixture Classification and Labels Creation System" (commonly known as NITE-Gmiccs,
hereinafter referred to as "this system") is a web system version of the "GHS Mixture Classification
System" (hereinafter referred to as "installed version") published on the GHS website of the Ministry of
Economy, Trade and Industry. Therefore, the basic logic of this system follows the installed version. Thissystem is a specification with some logic added to the classification principle below, and this document
describes the logic that this system uses.
The underlined parts of this document indicate that it is based on the own rules of this system. Thissystem does not consider the Bridging Principle, it performs classification only that can be done bycalculation. If there are test results that can be used as mixtures, they should be used for classification
as the first priority. If there are no such test results and the Bridging Principle can be applied,classification should be performed using the Bridging Principle and the results should be used to create
the SDS or label. For the details of GHS, please refer to United Nations GHS documents, related JIS
standards (Z7252:2019, Z7253:2019), “GHS classification guidance for enterprises” (2019 Revised
Edition by the Ministry of Economy, Trade and Industry).
Although this system allows GHS mixture classification to be carried out by users on their own, it isimportant to note that the result by this system is just an example of classification, and the user is
responsible for its use. Besides, the physical hazards, except some items, are not classified by this system.
The main targets of this system are health hazards and environmental hazards. Therefore, for thephysical hazards that are not classified in this system, the classification results performed by business
operator should be entered manually for creating the SDSs or labels.

Principle of classification
This system is based on the classification based on the "United Nations GHS Document, 6th Revised
Edition", and the classification based on the criteria adopted in the Japanese Industrial Standards(hereinafter referred to as "JIS Rules") and the classification based on the criteria not adopted in theJapanese Industrial Standards (hereinafter referred to as "UN Rules").
The basis of each classification is as follows:
Basic rule: UN GHS document, 6th revised edition
JIS
1. The range of GHS classification categories to use (selection based on the Building block approach) is basedon the "Classification of Chemicals Based on GHS" (JIS Z 7252:2019), and the higher value is used as theconcentration limit for the classification criteria of mixtures.2.
The names of the hazard classes and the hazard categories are based on the "Hazard Communicationof Chemicals Based on GHS— Labelling and Safety Data Sheet (SDS)" (JIS Z 7253:2019).
3.The classification logic of mixtures is based on the "Classification of Chemicals Based on GHS" (JIS Z
7252:2019) and the "GHS Classification Guidance for Enterprises" (revised edition in 2019, releasedby the Ministry of Economy, Trade and Industry).
UN
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NITE-Gmiccs Classification Logic
1. Classification is not selected by the building block approach, but all GHS classification categories are
adopted, and the lower value is used as the concentration limit, which is the classification standard
for mixtures.
2. The names of the hazard classes and the hazard categories are based on "Hazard Communication ofChemicals Based on GHS—Labelling and Safety Data Sheet (SDS)" (JIS Z 7253:2019) in
consideration of the use in Japan.
Besides, the GHS classification category and concentration limits adopted by "UN" or "JIS" are as follows.
Table 1 GHS classification category adopted by "UN" or "JIS"
Unstable

Category

Category

Category

Category

Category

Category

explosives

1.1

1.2

1.3

1.4

1.5

1.6

Flammable gases

1A

1B

2

Aerosols

12

3

Oxidizing gases

1

2

3

Compressed

Liquefied

Flammable liquids

1

2

Flammable solids

1

2

TYPE ATYPE B

Explosives

Gases under pressure

Self-reactive substancesand mixtures
Pyrophoric liquids

1

Pyrophoric solids

1

Self-heating substances

Refrigeratedliquefied

Dissolved

3

4

TYPE CTYPE D

TYPE E

TYPE F

TYPE GTYPE E

TYPE F

TYPE G

1

2

1

2

3

Oxidizing liquids

1

2

3

Oxidizing solids

1

2

3

Organic peroxides

TYPE ATYPE BTYPE CTYPE Dand mixtures
Substances and mixtures
which, in contact withwater, emit flammable
gases

Corrosive to metals andmixtures

1

Desensitized explosives

1

2

3

4

Acute toxicity

1

2

3

4

5*

Skin corrosion/irritation

1A

1B

1C

2

3*

1

2A

2B

Serious eye damage/eye
irritation

2

NITE-Gmiccs Classification Logic
Respiratory sensitization or

1

1A

1B

Germ cell mutagenicity

1A

1B

2

Carcinogenicity

1A

1B

2

Skin sensitization

Effects

Reproductive toxicity

1A

1B

2

on or via
lactation

Specific target organ
toxicity - Single exposure

1

2

3

1

2

1

2*

1

2

3

1

2

3

Specific target organ
toxicity - Repeatedexposure
Aspiration hazard
Hazardous to the aquatic
environment Short term
(Acute)Hazardous to the aquatic
environment Long term

4

(Chronic)
Hazardous to the ozone
layer

1

* Classification category not adopted by "JIS"In addition, see Table 2 for the concentration limits of the mixture whether to implement the GHS
classification adopted by "UN" or "JIS".
Table 2 Concentration limits adopted by "UN" or "JIS"Concentration limits adopted

Concentration limits adopted

by "JIS"by "UN"

Carcinogenicity Category 2

1.0%

0.1%

Reproductive toxicity Category 1A 1B

0.3%

0.1%

Reproductive toxicity Category 2

3.0%

0.1%

10%

1.0%

10%

1.0%

Specific target organ toxicity
Category 1
Specific target organ toxicity
Category 2

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NITE-Gmiccs Classification Logic
Effects on Aquatic Environment Decision
Since it had become a necessity to consider the United Nations GHS Document for the parts with vague
numbers, we implemented an original system for effects on aquatic environment.

4

NITE-Gmiccs Classification Logic
Multiple hazards and precedence of hazard information
In this system, if the chemical has multiple hazards, following precedence rules were determined according
to JIS Z7253:2019 and may be omitted some symbols or statements.
a) Precedence for the allocation of symbols
Generally, following precedence rules may be applied for the health hazards.
1) If the skull and crossbones applies, the exclamation mark should not appear.
2) If the corrosive symbol applies, the exclamation mark should not appear where it is used for skin or eye
irritation.
3) If the health hazard symbol appears for respiratory sensitization, the exclamation mark should notappear where it is used for skin sensitization or for skin or eye irritation.
b) Precedence for allocation of signal words
If the signal word “Danger” applies, the signal word “Warning” should not appear.
c) Precedence for allocation of hazard statements
All assigned hazard statements should appear on the label or SDS.
However, to avoid evident duplication or redundancy in the information conveyed by hazard statements,
the following precedence rules may be applied.
1) If the statement H410 “Very toxic to aquatic life with long lasting effects” is assigned, the statement
H400 “Very toxic to aquatic life” may be omitted.
2) If the statement H411 “Toxic to aquatic life with long lasting effects” is assigned, the statement H401
“Toxic to aquatic life” may be omitted.
3) If the statement H412 “Harmful to aquatic life with long lasting effects” is assigned, the statement H402
“Harmful to aquatic life” may be omitted.
4) If the statement H314 “Causes severe skin burns and eye damage” is assigned, the statement H318
“Causes serious eye damage” may be omitted.

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NITE-Gmiccs Classification Logic
2．Physical Hazards GuidanceClassification is basically not implemented for physical hazards. Depending on the physical and chemical
state of the selected mixture, only whether it is classifiable or not, based on Table 2.3.1 (Revision) below.
Note that although the physical state "aerosol" can be selected in this system, in this case, only the aerosol
item will be marked as "not classifiable," and "not applicable to classification (not subject to classification)"
will be stated for the other items.
Table 2.3.1(revised)Classification of Physical Hazards based on physical and chemical states
SectionHazard Class

Gas

Liquids

Solid

Aerosol

2.6.1

Explosives

×

○

○

×

2.6.2

Flammable Gases

○

×

×

×

2.6.3

Aerosols

×

×

×

○

2.6.4

Oxidizing Gases

○

×

×

×

2.6.5

Gases Under Pressure

○

×

×

×

2.6.6

Flammable Liquids

×

○

×

×

2.6.7

Flammable Solid

×

×

○

×

2.6.8

Self-reactive Substances and Mixtures

×

○

○

×

2.6.9

Pyrophoric Liquids

×

○

×

×

2.6.10Pyrophoric Solids

×

×

○

×

2.6.11

Self-heating Substances and Mixtures

×

○

○

×

×

○

○

×

2.6.12

Substances and mixtures which,in contact with water, emit flammable gases

2.6.13

Oxidizing Liquids

×

○

×

×

2.6.14

Oxidizing Solids

×

×

○

×

2.6.15

Organic Peroxides

×

○

○

×

2.6.16

Corrosive to Metals

○

○

○

×

2.6.17

Desensitized explosives

×

○

○

×

○: It is subject to classification and "Classification not possible" will be listed.
×: It is not subject to classification and "Not applicable" will be listed.

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NITE-Gmiccs Classification Logic
2.4.1 Relationship between UNRTDG classification and GHS Categorization, The cases in which the physicochemical hazards of a mixture can be classified by reference to the UNRTDG
classification ("UN No," "Hazard class (here referred to as “UN class”, “subsidiary risk”)" "Packing Group")
are shown according to the table below.
The shaded cells indicate items that cannot be classified by the system, the result is “Not classified”.
Table 2.4.1(revised) Comparison between GHS classification and UNRTDG classification
UNRTDG(Note: ( ) is a subsidiary risk)

GHS Category

Transport prohibited explosives

Unstable explosives

1.1

Division 1.1

1.2

Division 1.2

1.3

Division 1.3

1.4

Division 1.4

1.5

Division 1.5

1.6

Division 1.6

2.1 and 2.3(2.1)

Category1

GHS Class1)Explosives

Reference

UN class

UN class
subsidiary risk

2)Flammable Gases)

3)Aerosols4)Oxidizing Gases

5)Gases Under Pressure6)Flammable Liquids

2.2 and 2.3

Category2-

Category A-

Category B

2.1 and 2.3(2.1)
UN1950(aerosol)

Category１

2.1 and 2.3(2.1)
UN1950(aerosol)

Category2

2.2 and 2.3(2.1)
UN1950(aerosol)

Category3

2.2(5.1) or 2.3(5.1)

Category1

2.1 Flammable gases
2.2 Non-flammable, non-toxic
gases

Compressed gas
Liquefied gas
Refrigerated liquefied gas
Dissolved gas

3 PG I

Category1

3 PG II

Category2

3 PG III

Category3

Not dangerous goods(Flash point:60 °C or more)

Category4

4.1 PG II

Category1

4.1 PGIII

Category2

7)Flammable Solid

UN class
subsidiary risk

UN class
subsidiary risk

UN class
subsidiary risk

UN class
subsidiary risk

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NITE-Gmiccs Classification Logic
classification

UNRTDG(Note: ( ) is a subsidiary risk)

GHS Category

Transport prohibited
substancesType A

4.1、UN3221,3222,3231,3232

Type B

4.1、UN3223,3224,3233,3234

Type C

4.1、UN3225,3226,3235,3236

Type D

4.1、UN3227,3228,3237,3238

Type E

4.1、UN3229,3230,3239,3240

Type FNot dangerous goods

Type G9)Pyrophoric Liquids

4.2 PG I (liquid)

Category110)Pyrophoric Solids

4.2 PG I (solid)

Category1

4.2 PG II

Category1

4.2 PG III

Category1

8)Self-reactive
Substances and Mixtures11)Self-heating Substances and
Mixtures14)Oxidizing Solids

15)Organic Peroxides

UN class
UN number

Properties, UN class,
Package group

Properties, UN class,
Package group
UN class, Package group

4.3 PG I or 4.2(4.3)
12)Substances and mixtures which,in
4.3 PG II
contact with water, emit flammablegases
4.3 PG III

13)Oxidizing Liquids

Reference

Category1
Category2

UN class, Package group,
subsidiary risk

Category3

5.1 PG I (liquid)

Category1

5.1 PG II (liquid)

Category2

5.1 PG III (liquid)

Category3

5.1 PG I (solid)

Category1

5.1 PG II (solid)

Category2

5.1 PG III (solid)

Category3

Transport prohibited
substancesType A

5.2 UN3101,3102,3111,3112

Type B

5.2 UN3103,3104,3113,3114

Type C

5.2 UN3105,3106,3115,3116

Type D

5.2 UN3107,3108,3117,3118

Type E

5.2 UN3109,3110,3119,3120

Type FNot dangerous goods

Type G16)Corrosive to Metals

The UN dangerous goods
transport Class 8 includes Skin Category1
Corrosion17) Desensitized explosives

3, UN1204,2059,3064,3343,
3357,3379（liquid）

Category1

Properties, UN class,
Package group

Properties, UN class,
Package group

UN class
UN number

Properties, UN class,
UN number

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NITE-Gmiccs Classification Logic
4.1,
UN1310,1320,1321,1322,
1336,1337,1344,1347,1348,
1349,1354,1355,1356,1357,
1517,1571,2555,2556,2557,
2852,2907,3317,3319,3344,
3364,3365,3366,3367,3368,
3369,3370,3376,3380,3474（solid）-

Category2-

Category3-

Category4

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NITE-Gmiccs Classification Logic
2.5.2 Flammable Gases
2.5.2.6 Classification method of mixtures.
Flammability/combustibility should be determined by calculation in accordance with the below method.
In addition, this calculation method cannot exactly distinguish Category 1 from Category 2 but determine
whether it is within the range from Category 1 to Category 2. From the standpoint of safety, Category 1 is usedas the specifications of this system. Furthermore, if there is a component in the composition that cannot beclassified into any of inert gas, oxidized gas, and flammable gas, it is judged that it cannot be classified becauseof the shortage of data.

Calculation method (1)When consisting of flammable gases

n

Vi %
Tci
i

Wherein,Vi%,

each content of flammable gas;Tci,

the maximum concentration of the flammable gas
in nitrogen that makes the mixture not flammablein air;Value of Tci is described in ISO10156:2010
Table 2.

i;

the i-th gas in the mixture;n,n, the number of gases in the mixture, andKi,

the equivalence factor to inert gas/nitrogen.
Value of Ki, is described in ISO10156:2010
Table 1.

Judge as a flammable mixed gas if Tc is 1 or more.

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NITE-Gmiccs Classification Logic
Calculation method (2) When including 0.5% or more of oxidizing gases (oxygen etc.) as
ingredients in addition to inert gases and flammable gases:
Do the following calculation additionally.
If Tc < 1 and Tct2 ≥ 1, it may be flammable and should be checked by a test, but from thestandpoint of safety, Category 1 is used as the specifications of this system.

Where:
Ai:

concentrations of ingredient flammable gases;(The molecular weight is not Considered if physical state is gas.)Li:lower flammable limits of the gases. By referring to the ISO10156:2010.

In addition, in the absence of data on its pyrophoricity, a flammable gas mixture should be classified as apyrophoric gas if it contains more than 1% (by volume) of pyrophoric components.

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NITE-Gmiccs Classification Logic
2.5.4 Oxidizing Gases
2.5.4.6 Classification method of Mixtures
1.Classification JIS and UN GHS describe that tests or calculation methods should be performed according
to ISO10156: 2010. There is no equivalent classification in the Japanese Fire Service Act and HighPressure
Gas Safety Act. This test method is for determining the flammable range of the three-component systemof "oxidizing gas, ethylene, and nitrogen" and extremely complicated. Also, few tests have been done formixed gases.
2. An example of pure gas classified in this class is shown in Table 2.5.27 in the Guidance.
3. classification method described in ISO10156:2010 uses the criterion that a gas mixture should beconsidered as more oxidizing than air if the oxidizing power of the gas mixture is higher than 0.235(23.5%)
and the procedure is shown below.

The oxidizing power (OP) is calculated as follows:

Where:

OP =

∑

∑

+∑

Xi：molar fraction of the i:th oxidizing gas in the mixture;
Ci：coefficient of oxygen equivalency of the i:th oxidizing gas in the mixture;
Kk：coefficient of equivalency of the inert gas k compared to nitrogen;
Bk：molar fraction of the k:th in inert gas in the mixture;n：total number of oxidizing gases in the mixture;
p：total number of inert gases in the mixture;

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NITE-Gmiccs Classification Logic
2.5.6 Flammable Liquids
2.5.6.2 Classification criteria
A flammable liquid is classified in one of the four categories for this class according to the following table 2.5.31 based on the
flash point and initial boiling point of the mixture itself. Besides, If the flash point is lower than 23 ° C and the information on theinitial boiling point is insufficient, this system classifies as Category 1 from the viewpoint of safety.

Table 2.5.31 Criteria for flammable liquids
Category

Criteria

1

Flash point < 23° C and initial boiling point ≤ 35° C

2Flash point < 23° C and initial boiling point > 35° C

3Flash point ≥ 23° C and ≤ 60° C

4Flash point > 60° C and ≤ 93° C

13

NITE-Gmiccs Classification Logic
Notes at the classification of physical hazards
In the classification of physicochemical hazards, even if all components are "Not applicable " or " Notclassified", the category may need to be considered due to interaction between components.
Therefore, if the physicochemical hazards cannot be categorized by analogy, all of them are judged"Classification not possible."
When there are results of tests as mixtures done by users and it is possible for users to enter the physicalhazard classification category, it is required to enter it manually for creating labels.

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NITE-Gmiccs Classification Logic
3. Health Hazards Guidance (mixture)
3.5.1 Acute Toxicity
For the calculation of acute toxicity, this system is used only to calculate classification of mixtures basedon their components (the additivity formulas). If there are experimental data on acute toxicity or thebridging principle can be applied, it would be better to enter the results manually.
The classification category used in this system is almost based on NITE edited version (provisional: see
adopted rules ), but if it is necessary in the calculation, “Not classified (Not applicable)” is selected.
About the detail of adopted data, see appendix (notes of GHS list).

3.5.1.6 (5) If data is available for all or some of the components of the mixture. (Classification by additivity
formula)If data or information on all components does not exist or not enough information is available for theassessment, it is judged "Classification not possible," and the following process is not performed.
If the toxicity and concentration of each component of the mixture are known, the ATE of the mixture is
obtained from the ATE (acute toxicity estimate) of each component using the additivity formula of thefollowing formula 1 or formula 2, as shown in Table 3.5.1 (revised). If only the acute toxicity category isavailable, conversion to the acute toxicity estimate (ATE) is performed according to Table 3.5.10 (revised),
andcalculation is performed using this conversion value as the ATE of each ingredient. Besides, in the
JIS rule, the range of "Category 5" based on the UN GHS document is included in the range of "Notclassified". Therefore, if it corresponds to "Not classified" and no acute toxicity estimate (ATE) values isavailable, a conversion value corresponding to "category 5" is assigned and calculated.
The relevant ingredients of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids,
liquids, dusts, mists and vapors and v/v for gases). However, this does not apply if there is a reason tosuspect that an ingredient present at a concentration <1% is still relevant for classifying the mixture for
acute toxicity.
In this system, for Category 1 and Category 2, the ingredient to be considered is determined to be 0.1%
or more, referring to the UN GHS document 3.1.3.3 (a).

*Category 5 is based on the GHS document.
*Acute toxicity inhalation: For a vapour which is near the gaseous phases, classification should be basedon the units of ppmV (Parts per million per volume) as follows: Category 1 (100 ppmV), Category 2(500ppmV), Category 3 (2500 ppmV), Category 4 (20000 ppmV).
*Acute toxicity inhalation: For a vapour , two calculations in ppmV and in mg/L are performed. For
classification of mixtures (products), the result in ppmV is used. However, both of the results in ppmV
15

NITE-Gmiccs Classification Logic
and in mg/L need to be presented as the calculation basis. When only a value of either ppmV or mg/L
is available for ingredients in a mixture, the calculation is performed using the conversion value of thecategory corresponding to Table 3.5.10. (Ex: If only the toxicity value = 0.9 mg / L is available, thissystem uses the conversion value of Category 2 = 100 ppmV and calculates the ATEmix).
*The upper limit of a toxicity value to consider in the calculation is the estimate value in the range of
Category 5. If the value is (mathematically) higher than the limit, it is considered that it does not havetoxicity and included in the concentration (in the left part of the equation) but not in the acute toxicity(in the right part of the equation).
Table 3.5.1(revised): Acute toxicity hazard categories and acute toxicity estimate (ATE) values defining therespective categories
Exposure routeOral(mg/kg bodyweight)

Category 1

Category 2

Category 3

Category 4

Category 5ATE≦55＜ATE≦50

50＜ATE≦300

300＜ATE≦2000

2000＜ATE≦5000

200＜ATE≦1000

1000＜ATE≦2000

2000＜ATE≦5000

500＜ATE≦2500

2500＜ATE≦20000

20000＜ATE≦50000

2.0＜ATE≦10

10＜ATE≦20

20＜ATE≦50

0.5＜ATE≦1.0

1.0＜ATE≦5.0

5.0＜ATE≦12.5

Dermal(mg/kg bodyweight)
Inhalation:Gases(ppmV)
Inhalation:Vapours(mg/L)

ATE≦50

ATE≦100

ATE≦0.5

Inhalation:Dusts/mistsATE≦0.05(mg/L)

50＜ATE≦
200
100＜ATE≦
500
0.5＜ATE≦
2.0
0.05＜ATE≦
0.5

Table 3.5.10(revised) Conversion value for classification from experimentally obtained acute toxicity range
value (or acute toxicity category) on each exposure route.
Exposure routes

Oral(mg/kg bodyweight)

acute toxicity range estimate

Converted Acute
Toxicity point
estimate

0＜

Category1

≦5

0.5

5＜

Category2

≦50

5

50＜

Category3

≦300

100

300＜

Category4

≦2000

500

2000＜

Category5

≦5000

2500

5000＜ Not classified

Dermal(mg/kg bodyweight)

0＜

Category1

≦50

5

50＜

Category2

≦200

50

200＜

Category3

≦1000

300

1000＜

Category4

≦2000

1100
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NITE-Gmiccs Classification Logic
2000＜

Category5

≦5000

2500

5000＜ Not classified
0＜

Category1

≦100

10

100＜

Category2

≦500

100

500＜

Category3

≦2500

700

2500＜

Category4≦200004500

20000※1＜

Category5≦50000*1

25000*2

Inhalation:
Gases(ppmV)

50000＜ Not classified
0＜

Category1

≦0.5

0.05

0.5＜

Category2

≦2.0

0.5

Inhalation:

2.0＜

Category3

≦10.0

3

Vapours(mg/ l)10.0＜

Category4≦20.0

20.0 ＜Category5

※1

≦50.0

11
*1

25*2

50.0＜ Not classified
0＜

Category1

≦0.05

0.005

0.05＜

Category2

≦0.5

0.05

Inhalation:

0.5＜

Category3

≦1.0

0.5

Dust/mist(mg/ l)1.0＜

Category4

≦5.0

5.0 ＜

Category5

※1

≦12.5

1.5
*1

6.25*212.5＜ Not classified*1 This value is a system specification of this system and set to a value 2.5 times the upper limitof the estimated value in the range of Category 4 by following the upper limit of the estimatedvalue in the range of Category 5 from the upper limit of the estimated value in the range of
Category 4 of oral and dermal toxicities in the UN GHS documents.
*2 This value is a system specification of this system and set to a value of the estimated value
lower limit plus the estimated value upper limit divided by 10 in the range of Category 5 byfollowing the converted value of Category 5 of oral and dermal toxicities in the UN GHS
documents
1. Data available for all ingredients
The ATEmix of the mixture is determined by calculation from the ATE values for all relevant
ingredients according to the following formula below for oral, dermal, or inhalation toxicity.
However, if the classification of the relevant ingredient is "Not classified (Not applicable)", it isassumed that the ATE can be neglected and the calculation of the ingredients of "Not classified (Notapplicable)" is not performed.

100
ATEmix(Formula 1)nCi
i 1 ATEi

wherein:

ATEmix =Ci =ATE of the mixture
concentration of ingredient i

ATEi = Acute Toxicity Estimate of ingredient inshows the number of ingredients and i isrunning from 1 to n.
17

NITE-Gmiccs Classification Logic
2. When information of an ingredient or multiple ingredients of a mixture are not available, thefollowing methods may be applied.
If the concentration of the unknown component is greater than 10%, use the Formula 2 to calculate
the ATE of the mixture.
In the event that an ingredient without any useable information at all is used in a mixture at aconcentration ≥ 1%, the mixture should be classified based on the known ingredients only, andadditional statement “x% of the mixture consists of ingredient (s) of unknown toxicity” is describedin the classification result.Furthermore, this method generally requires expert judgment.

100(Formula 2)
wherein:C unknown if

10%

ATEmixCunknown if > 10%:nCi
i 1 ATEithe total percentage of the unknown ingredient(s) if theconcentration of the unknown ingredient (s) > 10%

ATEmix:
Ci:
ATEi:
n:

ATE of the mixture
concentration of ingredient i
Acute Toxicity Estimate of ingredient ishows the number of ingredients and i is running from
1 to n.

- Corrective action depending on selected classification
If the classification resulted in Category 5 and the selected classification is JIS, Category 5 is not
adopted, therefore, this system changes the result to "Not classified."- Processing when a hazard category is not given
As a result of following the procedure above, if the object is classified as "Not classified", the total
concentration of unknown components contained is equal to or more than the concentration to consider(0.1%), it is judged to be "classification not possible", whereas if it is lower than the concentration toconsider, it is judged to be "Not classified."- Corrective action depending on physical state of mixture
Only the physical state of mixture is “liquid” or “solid”, acute toxicity (Inhalation: Gases) is classified into
"Not classified (Not applicable)".

.

18

NITE-Gmiccs Classification Logic
3.5.2 Skin Corrosion/Irritation
For the calculation of skin Corrosion/Irritation, this system is used only to calculate classification of
mixtures based on their ingredients (the additivity formulas). If there are experimental data on skin
Corrosion/Irritation or the bridging principle can be applied, it would be better to enter the resultsmanually.
3.5.2.7 (3) If data is available for all or some of the ingredients of the mixture. (Classification using theconcentration limit)
If any ingredients with data or information for assessing Skin Corrosion/Irritation are included, thejudgments below (c) is performed.
If data or information on all ingredients does not exist or not enough information is available for theassessment, it is judged "Classification not possible," and the following process is not performed.
C) Classification of mixtures when data are available for all ingredients or only for some ingredients of the
mixtureThe ingredient to be considered in the mixture is a component existing at a concentration of 1% or more
(w/w for solids, liquids, dusts, mists, vapors, and v/v for gases). However, unless there is a possibility
that it may be related to the classification of the mixture even at a concentration of less than 1% like a
corrosive component, this is not the case.
In this system, it is determined with reference to the UN GHS document 3.2.3.3 that a ingredient to beconsidered is 0.1% or more for Category 1 and 1% or more for Category 2 and Category 3.
1. Classification of mixtures when the additivity approach applies for ingredients
If the skin corrosive component is below the concentration of Category 1 and is classified as skinirritant, 10 is used as the weighting coefficient. If the total concentration of each component exceeds
the concentration limit (see Table 3.5.22 (revised)), which is the classification standard, the mixture
is classified as skin corrosive / irritant.
Table 3.5.22(revised) Concentration of ingredients of a mixture when the additivity approach can apply,that would trigger classification of the mixture as hazardous to skin (skin corrosion/irritation)
Concentration triggering classification of a mixture as:
Sum of ingredients classified as:

Skin corrosive

Skin irritantCategory 1

Category 2

Skin Category 1≧5 %＜5 %、≧1 %Skin Category 2

－

≧10 %

＜10 %、≧1 %≧10 %Skin Category 3(10 x skin Category 1) + skin Category 2

Category 3

－

≧10 %

＜10 %、≧1 %(10 × Skin Category 1) + Skin Category 2≧10 %+ Skin Category 3
NOTE: In these cases, the sum of all ingredients of a mixture classified as skin Category 1A, 1B or 1C
respectively, should each be ≥ 5% in order to classify the mixture as either skin Category 1A, 1B or 1C. In
19

NITE-Gmiccs Classification Logic
case the sum of the skin Category 1A ingredients is < 5% but the sum of skin Category ingredients
1A+1B is ≥ 5%, the mixture should be classified as skin Category 1B. Similarly, in case the sum of skinCategory 1A + 1B is < 5% but the sum of Category 1A + 1B + 1C is ≥ 5% the mixture would be classified as
Category 1C.
・Corrective action depending on selected classification
If the classification resulted in Category 3 and the selected classification is JIS, Category 3 is not adopted
and therefore the result is classified as "Not classified."
・Processing when a hazard category is not given As a result of following the procedure above, if theobject is classified as "Not classified," the total concentration of unknown components contained is equal
to or more than the minimum value of the concentration to consider (0.1%), it is judged to be"classification not possible", whereas if it is lower than the minimum value of the concentration toconsider, it is judged to be "Not classified."
2. Classification of mixtures when the additivity approach can not apply for ingredients
For mixtures containing strong acids or bases, the pH should be used as classification criterion since
pH will be a better indicator of skin corrosive than the concentration limits in Table 3.5.22.
A mixture containing skin corrosive or skin irritation ingredients that cannot be classified based on
the additivity approach applied in Table 3.5.22 due to chemical characteristics, should be classified as
Category 1 when it contains ≧1% of a skin corrosive ingredients and as Skin Category 2 when it
contains ≧3% of an skin irritation ingredients. Classification of mixtures with ingredients for which
the approach in Table 3.5.22 does not apply is summarized in Table 3.5.23.
Table 3.5.23 Concentration of ingredients of a mixture when the additivity approach does not apply, thatwould trigger classification of the mixture as hazardous to skin
(skin corrosive / skin irritation）
Mixture classified
IngredientConcentration

as: Skin

Acid with pH≦2

≧1 %Category1

Base with pH≧11.5≧1 %Category 1

Other corrosive (Category1) ingredient※≧1 %Category 1≧3 %Category 2

Other irritant (Category2) ingredient ※ (including
acids and bases)※Inorganic salts, Aldehydes, Phenol, Surfactant or other ingredient

20

NITE-Gmiccs Classification Logic
3.5.3 Serious Eye Damage/Eye Irritation
For the calculation of Serious Eye Damage/Eye Irritation, this system is used only to calculate classificationof mixtures based on their components (the additivity formulas). If there are experimental data on Serious
Eye Damage/Eye Irritation or the bridging principle can be applied, it would be better to enter the resultsmanually.
3.5.3.7 (3) If data is available for all or some of the components of the mixture. (Classification using theconcentration limit)
The component to be considered in the mixture is a component existing at a concentration of 1% or more
(w/w for solids, liquids, dusts, mists, vapors, and v/v for gases). However, unless there is a possibility
that it may be related to the classification of the mixture even at a concentration of less than 1% like a
corrosive component, this is not the case.
In this system, it is determined with reference to the UN GHS document 3.3.3.3 that a ingredient to beconsidered is 0.1% or more for Category 1.
If any ingredients with data or information for assessing Serious Eye Damage/Eye Irritation are
included, the judgments below formula 1 is performed.
If data or information on all ingredients does not exist or not enough information is available for theassessment, it is judged "Classification not possible," and the following process is not performed.
1. Classification of mixture to which addition method can be applied.
Table 3.5.32 (revised) shows the concentration limit for judging whether the mixture is classified asserious eye damage / eye irritation.
If the skin corrosive component is below the concentration of Category 1 and is classified as skin irritant,
10 is used as the weighting coefficient.
If the total concentration of each component exceeds the concentration limit (see Table 3.5.32 (revised)),which is the classification standard, the mixture is classified as serious eye damage / eye irritation.

21

NITE-Gmiccs Classification Logic
Table 3.5.32(revised) Concentration of ingredients of a mixture when the additivity approach can apply,that would trigger classification of the mixture as hazardous to the eye(Serious eye damage/eye irritation)
Concentration triggering classification of a
mixture as:
Sum of ingredients classified as:

Serious Eye

Eye Irritation

DamageCategory 1

Category 2(b≧3 %≧1 % but ＜3 %

－

≧10 %

Eye Category 1 + skin Category 1(a10 x (skin Category 1 + eye Category 1)(a + eye
Category 2/2A/2Ba) If an ingredient is classified as both Skin Category 1 and Eye Category 1, its concentration is considered only once thecalculation.
b) In JIS, it is stated that Category 2 or 2A should be determined in the classification, but in this system, it is uniformly determined
as Category 2. However, since JIS states that a mixture can be classified as Category 2B when all relevant ingredients of the
mixture are classified as Category 2B, a mixture containing only ingredients classified as Category 2B is judged as Category
2B also in this system.

2. Classification of mixtures to which the addition method cannot be applied
For mixtures containing strong acid or strong alkali, pH is used as classification criteria (see Table
3.5.33).
It is classified as Eye category 1 when it contains 1% or more of a corrosive or serious eye damaging
ingredient, as Eye category 2 when it contains ≥ 3% of an eye irritant ingredient. Table 3.5.33 shows theconcentration limit for judging whether the mixture method cannot be applied to severe eye damage /eye irritation.
Table 3.5.33 Concentration of ingredients of a mixture when the additivity approach does not apply, thatwould trigger classification of the mixture as hazardous to the eye(Serious eye damage/eye irritation)
IngredientConcentration

Mixture classified as: Eye

Acid with pH ≤ 2≧1 %Category 1

Base with pH ≥ 11.5

≧1 %Category 1≧1 %Category 1≧3 %Category 2

Serious Eye Damage (Category 1)
Ingredients※
Other irritant (Category 2)※, including acids andbases※Inorganic salts, Aldehydes, Phenol, Surfactant or other ingredient• Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
22

NITE-Gmiccs Classification Logic
concentration of unknown components contained is equal to or more than the minimum value of theconcentration to consider, it is judged to be " Classification not possible " whereas if it is lower than theminimum value of the concentration to consider, it is judged to be " Not classified."

23

NITE-Gmiccs Classification Logic
3.5.4 Respiratory or Skin Sensitization
For the calculation of Respiratory Sensitization, this system is used only to calculate classification of
mixtures based on their components. If there are experimental data on Respiratory Sensitization or thebridging principle can be applied, it would be better to enter the results manually.
If any components with data or information for assessing Respiratory Sensitization are included,
perform the judgments below.
If data or information on all components does not exist or not enough information is available for theassessment, it is judged "Classification not possible," and the following process is not performed.
3.5.4.8 (3) If data is available for all or some of the components of the mixture. (Classification using theconcentration limit)
When at least one component is classified as respiratory sensitizer or skin sensitizer and each of solids,
liquids and gases exists at or above the respective concentration limits shown in table 3.5.46, themixture is classified as Respiratory Sensitizing Substance Category 1 or Skin Sensitizing SubstanceCategory 1.
In this system, if the respiratory sensitizer or skin sensitizer is below the concentration limit but
is present at a concentration of 0.1% or more, that fact is described in the classification rationale.
Table 3.5.46 Concentration limits of ingredients of a mixture classified as respiratory sensitizers

Ingredient classified as:

Respiratory
sensitizer

Skin sensitizer

Concentration limits triggering classification of a
mixture as:
Respiratory sensitizer
Skin sensitizer
Category 1
Category 1
All physical states
Solid/Liquid
Gas*1

Category 1≧ 1.0 %*2

≧0.2 %*2-

Category 1A≧ 0.1 %

≧ 0.1 %-

Category 1B≧1.0 %≧0.2 %-

Category 1--≧1.0 %*2

Category 1A--≧ 0.1 %

Category 1B--≧1.0 %*1: If the physical state is aerosol, it should be classified into gas and solid/liquid, their concentrations should be independently 100%
converted and calculated, and then the classification category of the highest hazard among them should be used as the classification of
the mixture. However, this system classifies it into gas for convenience.
*2: When the UN rule is selected in this system, the mixture is classified as category 1 when there is 0.1% or more of respiratory sensitizer
or skin sensitizer corresponding to category 1.

•

Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
concentration of unknown ingredients contained is equal to or more than the minimum value of the24

NITE-Gmiccs Classification Logic
concentration to consider, it is judged to be " Classification not possible " whereas if it is lower than theminimum value of the concentration to consider, it is judged to be " Not classified."25

NITE-Gmiccs Classification Logic
3.5.5 Germ Cell Mutagenicity
Calculation on germ cell mutagenicity in this system is performed only for classification based on ingredientof mixture; the presence of experimental data on the mixture itself and the application of the bridging
principle is not considered.
3.5.5.6 (1) If data is available for all or some of the ingredients of the mixture. (Method using theconcentration limit)
Classification of a mixture for germ cell mutagenicity is basically performed by using the concentration
limits of each ingredient as described below, based on the available data for each ingredient.
The mixture will be classified as a germ cell mutagen when at least one ingredient has beenclassified as a Category 1or Category 2 mutagen and is present at or above the concentration limit
as shown in Table 3.5.51 for Category 1 and 2, respectively.
Table 3.5.51 Concentration limits of ingredients of a mixture classified as germ cell mutagens
Ingredient classified as:

mutagenConcentration limits triggering classification of a mixture as:
Category 1ACategory 1A≧0.1 %

Category 1B―

Category 2

Category 1B―≧0.1 %―

Category 2――≧1.0 %―• Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
concentration of unknown components contained is equal to or more than the minimum value of theconcentration to consider, it is judged to be " Classification not possible " whereas if it is lower thanthe minimum value of the concentration to consider, it is judged to be " Not classified."

26

NITE-Gmiccs Classification Logic
3.5.6 Carcinogenicity
Calculation on carcinogenicity in this system is performed only for classification based on mixture
components; the presence of experimental data on the mixture itself and the application of the bridging
principle is not considered.
Classification of mixtures for carcinogen shall be basically performed based on the available data for each
ingredient by using the concentration limits as described later.
3.5.6.6 (1) Classification of mixtures when data are available for all ingredients or only for some ingredientsof the mixture. (Method using the concentration limit)
The mixture will be classified as a carcinogen when at least one ingredient has been classified as a
Category 1 or 2 carcinogen and is present at or above the concentration limit as shown in Table
3.5.58 for Category 1 and 2, respectively.
* Note*Even if an ingredient is present less than the concentration limit in the mixture, when a carcinogenclassified category 2 is contained at 0.1% or more, that fact should be specified on the SDS.
Table3.5.58 Concentration limits of ingredients of a mixture classified as carcinogens
Concentration limits triggering classification of a mixture as:
Ingredient classified as:

Category 1 carcinogen

Category 2 carcinogen

Category 1ACategory 1B

Category 1A carcinogen≧0.1 %－

Category 1B carcinogen－≧0.1 %－－

Category 2 carcinogen－－≧1.0 %*1*1: When the UN rule is selected in this system, the mixture is classified as class2 when there is 0.1% or more of carcinogen corresponding
to class 2.

• Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
concentration of unknown components contained is equal to or more than the minimum value of theconcentration to consider, it is judged to be " Classification not possible " whereas if it is lower than theminimum value of the concentration to consider, it is judged to be " Not classified."27

NITE-Gmiccs Classification Logic
3.5.7 Reproductive Toxicity
Calculation on reproductive toxicity in this system is performed only for classification based on mixture
components; the presence of experimental data on the mixture itself and the application of the bridging
principle is not considered.
The reproductive toxicity classification of mixtures is basically performed by using the concentration limitsof each ingredient as described below, based on the available data for each ingredient.
3.5.7.6 (1) Classification of mixtures when data are available for all ingredients or only for some ingredientsof the mixture. (Method using the concentration limit)
1) The mixture will be classified as a reproductive toxicant when at least one ingredient has beenclassified as a Category 1or 2 reproductive toxicant and is present at or above the concentration
limit as shown in Table 3.5.67 for Category 1 and 2, respectively.
2) The mixture will be classified for effects on or via lactation when at least one ingredient has beenclassified for effects on or via lactation and is present at or above the concentration limit as shownin Table 3.5.67 for the additional category for effects on or via lactation.
* Note*Even if an ingredient is present less than the concentration limit in the mixture, when it iscontained at 0.1% or more, that fact should be specified on the SDS.
In this system, when the substances of Category 1A and Category 1B are present at concentrationof 0.1% ≤ n <0.3% in the mixture, that is described in "Rationale for the classification".
Table3.5.67 Concentration limits of ingredients of a mixture classified as reproductive toxicants*

Ingredient classified as:

Category 1A
reproductive toxicant
Category 1B
reproductive toxicant
Category 2
reproductive toxicant
Additional category for
effects on or via lactation

Concentration limits triggering classification of a mixture as:
Category 1
Additional
Category 2
reproductive toxicant
category forreproductive
effects on or via
toxicant
Category 1ACategory 1B
lactation－≧0.3 %－－－≧0.3 %－－－≧3.0 %

－

－

－

－
－
≧0.3 %* When the UN rule is selected in this system, all ingredients of o.1% or more are taken into account for reproductive toxicants andadditional category in the table.

• Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
concentration of unknown components contained is equal to or more than the minimum value of theconcentration to consider, it is judged to be " Classification not possible " whereas if it is lower than28

NITE-Gmiccs Classification Logic
the minimum value of the concentration to consider, it is judged to be " Not classified."29

NITE-Gmiccs Classification Logic
3.5.8 Specific Target Organ Toxicity-Single Exposure
For the calculation of specific target organ toxicity-single exposure, this system is used only to calculateclassification of mixtures based on their components. If there are experimental data on specific target organ
toxicity-single exposure or the bridging principle can be applied, it would be better to enter the resultsmanually.
If any components with data or information for assessing specific target organ toxicity-single exposure, areincluded, the judgments below is performed.
If data or information on all components does not exist or not enough information is available for theassessment, it is judged "Classification not possible," and the following process is not performed.
3.5.8.6 (3) Classification of mixtures when data are available for all ingredients or only for some
ingredients of the mixture (using concentration limit)
A mixture will be classified as a specific target organ toxicant (single exposure) when at least one
ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant (single
exposure) and is present at or above the concentration limit as mentioned in Table 3.6.18 for Category
1 and 2 respectively.
The concentration limit is set at 10%, referring to JIS.
Table 3.5.73 Concentration limits of ingredients of a mixture as a specific target organ toxicant thatwould trigger classification of the mixture as Categories 1 and 2
Ingredient classified as:Specific target organ Category 1
toxicant(Singleexposure)
Category 2

Concentration limits triggering classification of a mixture as:
Category 1

Category 2≧10 % *1

1.0 %≦ ingredient ＜10 %－≧10 %*1*1: When the UN rule is selected in this system, a component of 1% or more is taken into account for a specific target organ toxicant.

* Note*･Even if an ingredient is present less than the concentration limit in the mixture, when it iscontained at 1% or more, that fact should be specified on the SDS.
･Care should be exercised when toxicants affecting more than one organ system are combined thatthe potentiation or synergistic interactions are considered, because certain substances cancause specific target organ toxicity at <1% concentration when other ingredients in the mixture
are known to potentiate its toxic effect.
(4) When extrapolating toxicity of a mixture that contains Category 3 ingredient(s)If a mixture contains ingredients applicable to Category 3 for its respiratory tract irritation or narcotic
effects, the concentrations of the ingredients shall be summed up for each effect and if the sum becomes
30

NITE-Gmiccs Classification Logic
20% or more, the mixture is classified in Category 3 based on the effect.
• Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
concentration of unknown ingredients contained is equal to or more than the minimum value of theconcentration to consider, it is judged to be " Classification not possible " whereas if it is lower than theminimum value of the concentration to consider, it is judged to be " Not classified."

31

NITE-Gmiccs Classification Logic
3.5.9 Specific Target Organ Toxicity-Repeated Exposure
For the calculation of specific target organ toxicity- repeated exposure, this system is used only to calculateclassification of mixtures based on their components. If there are experimental data on specific target organ
toxicity- repeated exposure or the bridging principle can be applied, it would be better to enter the resultsmanually.
3.5.9.6 (3) Classification of mixtures when data are available for all ingredients or only for some
ingredients of the mixture (using concentration limit)
The mixture will be classified as a specific target organ toxicity substance (specific organ designation)
as a result of a single exposure, repeated exposure, or both when at least one ingredient has beenclassified as a Category 1 or Category 2 specific target organ toxicant (repeated exposure) and is present
at or above the concentration limit as mentioned in Table 3.6.78 for Category 1 and 2 respectively.
The concentration limit is set at 10% referring to JIS.
Table 3.5.78 Concentration limits of ingredients of a mixture as a specific target organ toxicant that would
trigger classification of the mixture
Ingredient classified as:

Concentration limits triggering classification of a mixture as:Specific target
Category 1
organ toxicant(Repeated
Category 2
exposure)

Category 1

Category 2≧10 %*1

1.0 %≦ ingredient＜10 %≧10 %*1*1: When the UN rule is selected in this system, a component of 1% or more is taken into account for a specific target organ toxicant.

* Note*･Even if an ingredient is present less than the concentration limit in the mixture, when it iscontained at 0.1% or more, that fact should be specified on the SDS.
･Care should be exercised when toxicants affecting more than one organ system are combined thatthe potentiation or synergistic interactions are considered, because certain substances cancause specific target organ toxicity at <1% concentration when other ingredients in the mixture
are known to potentiate its toxic effect.

• Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
concentration of unknown ingredients contained is equal to or more than the minimum value of theconcentration to consider, it is judged to be " Classification not possible " whereas if it is lower than theminimum value of the concentration to consider, it is judged to be " Not classified."

32

NITE-Gmiccs Classification Logic
3.5.10 Aspiration Hazard
For the calculation of aspiration hazard, this system is used only to calculate classification of mixtures
based on their components. If there are experimental data on aspiration hazard or the bridging principle
can be applied, it would be better to enter the results manually.
3.5.10.6 (3) Classification of mixtures when data are available for all ingredients or only for some ingredientsof the mixture (using concentration limit)
In the mixture, components present at a concentration of 1% or more are considered.
The component concentration classified as Category 1 is shown in Table 3.5.82.
Table 3.5.82 Concentration of ingredient for classification of mixtures by additivity approach(Aspiration Hazard)
IngredientCategory 1(kinematic viscosity ≤ 20.5 mm2/s, at 40°C.)
In case of a mixture which separates into two or
more distinct layers, one of which contains ≥ 10% of
an ingredient classified in Category 1(kinematic viscosity ≤ 20.5 mm2/s, at 40°C.)

Concentration

Classification≧10％

Category 1≧10％

Category 1

・A mixture with a kinematic viscosity higher than 20.5 mm 2 / s is “Not classified”.
• Corrective action depending on selected classification
If the classification resulted in Category 2 and the selected classification is JIS, Category 2 is not
adopted and therefore the result needs to be classified into " Classification not possible."• Processing when a hazard category is not given:
As a result of following the procedure above, if the object is classified out of category, the total
concentration of unknown ingredients contained is equal to or more than the minimum value of theconcentration to consider, it is judged to be " Classification not possible " whereas if it is lower than theminimum value of the concentration to consider, it is judged to be " Not classified."

33

NITE-Gmiccs Classification Logic
4. Environmental Hazards Guidance
4.4.1 Hazardous to the Aquatic Environment – Acute Hazard
For the calculation of hazardous to aquatic environment-acute hazard, this system is used only to calculateclassification of mixtures based on their components. If there are experimental data on hazardous toaquatic environment-acute hazard or the bridging principle can be applied, it would be better to enter the
results manually.
Classification methods of mixtures (For Hazardous to the aquatic environment Short term (Acute))
If any components with data or information for assessing hazardous to aquatic environment-acute hazard,
are included, the judgments below is performed.
If data or information on all components does not exist or not enough information is available for theassessment, it is judged "Classification not possible," and the following process is not performed.
1. Not relevant ingredients
For "Not relevant ingredients " in Hazardous to the Aquatic Environmental, no numerical values are
specified as the specifications of this system and all components are subject to calculation.
2. For Hazardous to the Aquatic Environmental, calculations are done by the three kinds of methods of A, B,
and C below according to the GHS rules, and it is specified that the most conservative one is used fromthe standpoint of safety.
(2-1) Calculation method A※ Calculation method A is carried out when there are two or more ingredients with toxicity value dataof three trophic levels (fishes, crustacea, algae or other aquatic plants).
2-1-1 Determine the category for each of the three trophic levels (fishes, crustacea, algae or otheraquatic plants).
2-1-1-1 Additivity formula (* Refer to Eq. 4-4-1.)
For each of the three trophic levels, determine the category from the components with toxicity
values using the additivity formula.
It is allowed to assign acute toxicity category to the mixture part using this calculated toxicity
value and then apply it to the summation method.
2-1-1-2 addition formula (* Refer to Eq. 4-4-1)
Toxicity value data for three trophic levels are not available, but at least one is for toxicity value
data, the strongest toxicity value is adopted for each ingredient, and the classification is obtainedby addition formulas.
2-1-1-3 Summation method
Following the summation method, classify from the content percentage of components without
toxicity values but with categories and from the content percentage of the categories determinedin 2-1-1-1 and 2-1-1-2.
34

NITE-Gmiccs Classification Logic

2-1-2 Classification
From the results of each of the three trophic levels obtained in 2-1-1, use the category with thehighest toxicity as the category of the mixture.
(2-2) Calculation method B
2-2-1 Of the three trophic levels, use the level with the highest toxicity value for each component anddetermine categories by the summation equation.
2-2-2 Following the summation method, determine the categories of the mixtures from the components
without toxicity values but with categories and from the categories determined in 2-2-1.
(2-3) Calculation method C
Determine categories of mixtures only by the summation method without using the additivity formula.
3. Processing when a hazard category is not given.
In the case any classification not applied as a result of process described above, it is judged as “classification
not possible” if mixture contains unknown component, or, it is judged as “not classified” if mixture notcontains any unknown component.
formula 4-4-1 Additivity formula

Where:Ci
L(E)C50in
L(E)C50m

concentration of ingredient i (weight percentage)
LC50 or EC50 for ingredient i (mg/L)
number of ingredients, and i is running from 1 to n
L(E)C50 of the part of the mixture with test data

The calculated toxicity shall be used to assign that portion of the mixture an acute hazard category
which is then subsequently used in applying the summation method;
For Category 1, determine the toxicity multiplying factor M simultaneously with reference to Table
4.5.4(Rev1) and use it later for the summation method.
Table 4.4.18 Summation method; Classification of a mixture for acute hazards based onsummation of the concentrations of classified ingredients
Sum of the concentrations (in%) of ingredients classified as:

Mixture is classified as:

Acute 1 x Ma ≥ 25%

Acute 1

(M x 10 x Acute 1) + Acute 2 ≥ 25%

Acute 2

(M x 100 x Acute 1) + (10 x Acute 2) + Acute 3 ≥ 25%

Acute 335

NITE-Gmiccs Classification Logic
Table 4.4.20(Rev1) M (toxicity multiplying factor) for ingredients with highly acute toxicity of
mixturesCalculation result

M: toxicity multiplying factor

0.1＜

Calculation result

≦1

1

0.01＜

Calculation result

≦0.1

10

0.001＜Calculation result

≦0.01

100

0.0001＜

Calculation result≦0.0011000

0.00001＜

Calculation result≦0.0001

10000(continue in factor 10 intervals)

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NITE-Gmiccs Classification Logic
For the calculation of hazardous to aquatic environment-long-term hazard, this system is used only to
calculate classification of mixtures based on their components. If there are experimental data on hazardous
to aquatic environment-acute hazard or the bridging principle can be applied, it would be better to enter
the results manually.
Classification methods of mixtures for hazardous to the aquatic environment Long term (Chronic)
1. Not relevant ingredients
For " Not relevant ingredients " in Hazardous to the Aquatic Environmental, no numerical values are
specified as the specifications of this system and all components are subject to calculation.
2. For Hazardous to the Aquatic Environmental, calculations are done by the three kinds of methods of A, B,
and C below according to the GHS rules, and it is specified that the most conservative one is used fromthe standpoint of safety.
(2-1) Calculation method A※ Calculation method A is carried out when there are two or more ingredients with
toxicity value data of three trophic levels (fishes, crustacea, algae or other aquaticplants).
2-1-1 Determine the category for each of the three trophic levels (fishes, crustacea, algae or otheraquatic plants).
2-1-1-1 additivity formulas (* Refer to Eq.4-4-2.)
For each of the three trophic levels, determine the category from the components with toxicity
values using the additivity formula.
It is allowed to assign acute toxicity category to the mixture part using this calculated toxicity
value and then apply it to the summation method.
2-1-1-2 Additivity formula (* Refer to Eq. 4-4-2)
Toxicity value data for three trophic levels are not available, but at least one is for toxicity value
data, the strongest toxicity value is adopted for each ingredient, and the classification is obtainedby addition formulas.
2-1-1-3 Summation method
Following the summation method, classify from the content percentage of components without
toxicity values but with categories and from the content percentage of the categories determinedin 2-1-1-1 and 2-1-1-2.
2-1-2 Classification
From the results of each of the three trophic levels obtained in 2-1-1, use the category with thehighest toxicity as the category of the mixture.
(2-2) Calculation method B
2-2-1 Of the three trophic levels, use the level with the highest toxicity value for each component anddetermine categories by the summation equation.
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NITE-Gmiccs Classification Logic
2-2-2 Following the summation method, determine the categories of the mixtures from the components
without toxicity values but with categories and from the categories determined in 2-2-1.
(2-3) Calculation method C
Determine categories of mixtures only by the summation method without using the additivity formula.
3. Processing when a hazard category is not given:
As a result of following the procedure above, if no categories are obtained, classify it into "Classification
not possible" in the case where unknown components are present or out of category in the case where
unknown components are not present.
Formula 4-4-2 Additivity formulawhere :
Ci

concentration of ingredient i (weight percentage) covering
the rapidly degradable ingredients;

Cj

concentration of ingredient j (weight percentage) covering
the non-rapidly degradable ingredients;NOECi

NOEC (or other recognized measures for chronic toxicity)
for ingredient i covering the rapidly degradable ingredients,
in mg/L;NOECjNOEC (or other recognized measures for chronic toxicity)
for ingredient j covering the non-rapidly degradable
ingredients, in mg/L;nnumber of ingredients, and i and j are running from 1 to n;

EqNOECm

equivalent NOEC of the part of the mixture with test data;

For Category 1, determine the toxicity multiplying factor simultaneously with reference to Table4.4.20
and use it later for the summation method.
Table 4.4.20 M (toxicity multiplying factor) for ingredients with high toxicity of mixtures
acute toxicity

M factor

L(E)C50 value

Chronic toxicity

M factor

NOEC value

NRD(a

RD(b

0.1＜L(E)C50≦110.01＜NOEC≦0.1

1－0.01 ＜L(E)C50≦0.1

100.001＜NOEC≦0.01

10

10.001＜L(E)C50≦0.01

100

0.0001＜NOEC≦0.001

100

10

0.0001＜L(E)C50≦0.001

1000

0.00001＜NOEC≦0.0001

1000

100

0.00001＜
L(E)C50≦0.0001

10000

0.000001＜
NOEC≦0.00001

10000

1000

(continue in factor 10 intervals)a)NRD: Non-rapidly degradable ingredients(continue in factor 10 intervals)b)RD: Rapidly degradable ingredients

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NITE-Gmiccs Classification Logic
Table4.4.19 (revised) Summation method; Classification of a mixture for chronic hazards based onsummation of the concentrations of classified ingredients
Sum of the concentrations (in %) of ingredients classified as:

Mixture is classified as:

Chronic 1 x M ≥ 25%

Chronic 1(M x 10 x Chronic 1) + Chronic 2 ≥ 25%

Chronic 2(M x 100 x Chronic 1) + (10 x Chronic 2) + Chronic 3 ≥ 25%

Chronic 3

Chronic 1 + Chronic 2 + Chronic 3 + Chronic 4 ≥ 25%

Chronic 4* Category 4 is a safety net classification applied to the case where there is data showing the possibility ofchronic toxicity and data on acute toxicity cannot be obtained and cannot be incorporated into thesystem. Therefore, it is not judged in this system. However, in the case where there is a basis of chronic
hazards of mixtures but there is no data on acute hazards, it is allowed to enter "Long-term Category 4"
manually.

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NITE-Gmiccs Classification Logic
4-4-2 Hazardous to the ozone layer
・Classification criteria for hazardous to ozone layer
For classification of hazards to the ozone layer in this system, the classification is performed only in thefollowing case.
(4) Classification methods of mixtures
Any mixture containing at least one ingredient listed in the Annexes to the Montreal Protocol, at aconcentration ≥ 0.1% shall be classified as Category 1.

40

NITE-Gmiccs Classification Logic<Update history>
Revision dateMaterial

1, April, 2021

Whole

8, July, 2021

2.5.6 Flammable Liquids

Added the details of classification

3.5.1 Acute Toxicity

logic and supplementary descriptions

3.5.1 Acute Toxicity

Partial modification of classification

31, March, 2022

ReasonVersion
1.00
1.01
2.0

logic (calculation method for "Notclassified" ingredient).
April, 2022

Multiple hazards and

Added the multiple hazards andprecedence of hazard

precedence of hazard information

2.1

information
3.5.1 Acute Toxicity

Added the converted acute toxicity
point estimate of “Not classified”
without toxicity range value

3.5.3 Serious Eye

Added the individual classification

Damage/Eye Irritation

logic in this system for serious eye
damage/eye irritation

Whole

Added the concentration to consider
or the concentration limit value forthe total concentration of unknown
components

April, 2023

November, 2023

3.5.3 Serious Eye

Added the details of classification

Damage/Eye Irritation

logic and supplementary descriptions

3.5.3 Serious Eye

Added revised classification logic ofDamage/Eye Irritation

serious eye damage/eye irritation

Whole

Corrected several errors

1. Introduction

Added/delete principles of

2.2
2.3

2.4

classification
2. Physical Hazards Guidance

Basically, since the classification is
not implemented, removed orcorrected misleading wording.

3.5.2 skin corrosion/irritation

Added supplementary description

3.5.3 Serious Eye

Added supplementary description

Damage/Eye Irritation
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NITE-Gmiccs Classification Logic
4. Environmental Hazards

Corrected table numbers

Guidance42