Status of Chemical Management
Policy in Japan
June 23, 2018
The 12th Tripartite Policy Dialogue on Chemical Management
Policy in China, Japan and Korea

Akira Nitta
Director of Chemical Evaluation Office,Environmental Health Policy Planning and Management Division,
Environmental Health Department, Minister's Secretariat,
Ministry of the Environment1

<Table of Contents>(1)

Overview of Chemical Substances Control
Law (CSCL)(2) Evaluation of New Chemical Substances /Risk Assessment of Existing Chemical
Substances, etc.
(3) Revision of CSCL

Emission factor for Exemption Rule of Small or
Low volume New Chemical Substances
Criteria for Specific New Chemical Substances
2

① Overview of Chemical Substances
Control Law (CSCL)

3

Role of the Chemical Substances Control Law in Japanese Chemical Substance Control
 In Japan, chemical substances are regulated under a variety of laws according to their exposure routeand life cycle stage, etc.
 The objective of CSCL is to assess any long-term toxicity to humans via the environment, and theireffect on living environments and ecosystems.

Exposure
HazardUse

Emission/Discharge

Disposal

CrisisManagement

Law on the Prohibition ofChemical Weapons and theRegulation of Specific Chemicals

Waste Management andPublic Cleaning Act

Water Pollution Control Act

Air Pollution Control Act

Law Concerning Pollutant Release
and Transfer Register(PRTR)

Agricultural Chemical Control
Act

Chemical Substances Control Law(CSCL)

Building Standards Act(sick building syndrome, etc.)

Household Goods Regulation Act

Household Goods Quality
Labeling Act

Pharmaceutical Medical Devices Law

Food Sanitation Act

Impact on Human Health

Manufacture

Agricultural Chemical Control Act

Greenhouse
EffectAgricultural Chemical Control Act

Ozone Layer
Depletion
Potential

Industrial Safety and Health Act

Effect on Living
Environments(Including animals
and plants)

Consumer

Poisonous and Deleterious
Substances Control Act

Acute Toxicity

Chronic(Long-Term)
Toxicity

Via Environment

Working
Environment

Act on Preventing Environmental
Pollution of Mercury

Ozone Layer
Protection Law

Law Concerning the Recovery and Destructionof Fluorocarbons

4Outline of the Preliminary Evaluation System for New Chemical Substances Under CSCLNew Chemical Substances
Exception Rule

Regular Evaluation
for New Chemical Substances

Notifiers submit data on(1) degradability, (2) accumulative
properties, (3) toxicity on human healthand the environment

Manufacture and Import volume
within 10t/Year(Individual Company)

Manufacture and Import volume
within 1t/Year(Individual Company)

Intermediates · Closed
Applications · Export Only Items

Low Concern Polymer
Compounds

Prior confirmationby the Government

Prior confirmationby the Government

Prior confirmationby the Government

Notifiers submit data on (1)degradability, (2) accumulative
properties

Evaluation by theGovernment

Evaluation by theGovernment* Amended from production andimport volumes to environmental
emissions

Low Accumulation

National
Pre-Confirmation

Environmental Emissions within
1t/Year (Nationwide)* Amended from production and import
volumes to environmental emissions

Manufacture/Import
Permitted

Environmental Emissions within 10t/Year(Nationwide)* Number of substances as of April 2018
<Requirement 1>- Persistent- High accumulation properties- Long-term toxicity to humans or high-order predators

Class 1 Specified Chemical
Substances (33 Substances)- Manufacturing/import permission system (virtuallyprohibited)- Prohibition on importation of ordinance-designatedproducts- Prohibition of use outside ordinance-designated use- Conformity to handling standards for substances andordinance-designated products (substance-using
products)/labeling duty
- Administrative orders for recall from the market.

<Requirement 2>- Persistent- Suspected long-term toxicity to humans and/or
toxicity to animals and plants<Requirement 3>- Does not fall under Requirements 1 and 2

Risk is high from the viewpoint of combined toxicity
and environmental emissions

NO

Significant long-term toxicity to humans or living
environments, animals and plants

YES
YES

Priority Assessment Chemical
Substances (208 Substances)* New definition

Specific General Chemical
Substances* Specific New Chemical Substances before Public Announcement- Notification of manufacturing/import volumes, detailed
use application, etc.
- For handling operators: (1) obligation to convey
information, (2) guidance/advice from the country
concerning the handling method, (3) reporting on thehandling situation to the government

NO- Notification of manufacturing/import volumes, usage
application.
- For handling operators: (1) obligation to convey
information, (2) guidance/advice from the country
concerning the handling method, (3) reporting on thehandling situation to the government

General Chemical Substances(About 28,000 Substances)* New Chemical Substances before Public
Announcement- Notification of manufacturing/import volume,
usage application

5

Screening Assessment / Risk Assessment of General Chemical Substances etc.
General Chemical Substances (About 28,000 Substances)(Existing chemical substances / newly evaluated chemical substances /specified general (new) chemical substances, etc.)* Number of substances as of May 2018

Notification of Manufacturing/Import
volumes (more than 1 ton/year), useapplication, etc. by business operators

Screening Assessment by thegovernment

Risk is high from the viewpoint of combined toxicity and environmental emissions

Priority Assessment Chemical
Substances (208 Substances)
Risk Assessment by thegovernment

Persistent and high accumulative properties, and longterm toxicity to humans or high-order predators is
unknown

Monitoring Chemical Substances(38 Substances)· Notification of manufacturing, import volumes, detailed
use application, etc.
· Obligation to communicate information to handlingbusinesses

If necessary
Handling Condition Report
RequestIf necessary based on
Risk Assessment results
Hazard Information, handlingcondition report request
If necessary based on Risk
Assessment results

If necessary
Hazard Survey Instructions

Hazard Survey Instructions
Long-term toxicity to humans or high-tier predators

Risk to humans or living environments, animals and plants over considerably wide areas

Class I Specified Chemical Substances (33 Substances)Class II Specified Chemical Substances (23 Substances)- Notification of manufacture, import (scheduled and actual), volumes, use applicationetc.
- Order for changing the planned manufacturing/import volumes as necessary- Publication of substances and handling technical guidelines for designated products- Labelling obligation of designated products specified by the government- Manufacturing/import permission system (virtually prohibited)- Prohibition of importation of ordinance-designated products- Prohibition of use outside ordinance-designated use- Conformity to handling standards for substances and ordinancedesignated products (substance-using products)/labeling obligation- Administrative orders for recall from the market

6

② Evaluation of New Chemical
Substances / Risk Assessment of
Existing Chemical Substances, etc.

7

Test Items for Evaluation of New Chemical Substances Tests to be submitted by business operators with regular evaluation of
new chemical substances
Over 10t
Bioaccumulation study1)

Repeated dose 28-day toxicity study in mammals

1)Bacterial reverse mutation test

1)
1)
1)
1)
1)

Biodegradation study

Cultured mammalian cell chromosome aberration test
Algae growth inhibition test

Daphnia acute immobilization test
Acute fish toxicity test
1) Readily degradable substances require results from the degradation test only.

8

Status of Evaluation New Substances in FY2017
Deliberations made by the Subcommittee on Chemical Substances, Chemical Substances Committee on Safety Measures
Against Chemical Substances, Pharmaceutical Affairs Commission, Pharmaceutical Affairs and Food Sanitation Council,
the Evaluation Committee, Chemical Substances Council and the Subcommittee on Chemical Substance Evaluation,
Environmental Health Committee, Central Environment Council, and on the basis of the degradability, accumulation,
human toxicity and ecotoxicity submitted by business operators.

Date
2017

2018

Number of New Substances

April 2122

May 2621

June 23

26

July 2829

September 22

38

October 27

31

November 24

23

December 22

20

January 19

30

March 2344
9

Judgments on New Chemical Substances (Article 4)
Regular Evaluation and Judgments on New Chemical Substances (FY2017 Results)
No. of Judgments

No. of
Reviews

No. 1

No. 2

No. 3

No. 4

No. 5

No. 6

284

0

10

6

34

167

0

* Regular new substances based on polymer flow schemes, as well as those subjected only to the degradation test, are also included.

(1) Items falling under any of the items in Article 2, Paragraph 2 (Class I Specified
Chemical Substances) ... No. 1(2) When persistent in the degradation test but is judged to be not highly accumulative
via the accumulation test or the Pow analysis ... No. 2 - No. 5
No. 2: Human health toxicity yes, eco-toxicity no
No. 3: Human health toxicity no, eco-toxicity yes
No. 4: Human health toxicity yes, eco-toxicity yes
No. 5: Human health toxicity no, eco-toxicity no(3) When judged to be of good degradability with the degradation test … No. 5(4) When it is unclear if it falls under No. 1 through No. 4 … No. 6
Review and Judgments on Low Production Volume New Chemical Substances(below 10 tons/year nationwide) (FY2017 results)
No. of Reviews

No. of Judgments

121

121

* Low production volumes for new chemical substances based on polymer flow schemes are also included. 10

Preliminary Evaluation and Prior Confirmation of New Chemical Substances Manufacturing and import allowed after notification of new chemical substances and regular preliminary
evaluations. [new (regular)] Manufacturing and import can be allowed after preliminary declaration and prior confirmation without making
regular notification. (special evaluation exemption scheme, notification exemption scheme) [new (low production
volume), new (small amount), highly polymerized compound of low concern, intermediate substance, etc.]
 Japan’s chemical industry is making a shift to the small-amount various-type approach. The system was designed
in a rational manner in consideration of the small-amount various-type industry, with prevention of any
environmental pollution by chemical substances as a precondition. Depending on the individual procedure
differing types of information (e.g. hazardous properties) are submitted to the government body.
Procedure type

ClauseProcedure

Hazardous property
data to be submitted at
the time of notification

Other supporting data

New (regular)

Article 3.1of ActNotification
 Decision

Degradability,
Accumulation, Human
Health, Ecological EffectIntended use, planned
quantity, etc.

No

New (small amount)

Article 3.1.5of ActDeclaration
Confirmation―

Intended use planned
quantity, etc.

Wholecountry
1 t orless

New (low production
volume)Article 5.1of ActDegradability,
Notification
accumulation (if available, Decisionsubmit hazardous
Declaration
property data on human
health, ecological effect at
Confirmation
the time of notification)

Intended use, planned
quantity, etc.

Polymers of low
concern

Article 3.1.6of ActDeclaration
Confirmation

Intermediate
substance, closed
use, export only
Small-amountintermediate
substance, etc.

Article 3.1.4of ActDeclaration
Confirmation――

Quantity Quantity
upper adjustlimit
mentFrequency ofacceptance

Actual Number ofcases in FY 2016

No

10 times/FY

284 cases

Yes

4 times/FY

35,781 cases

Wholecountry
10 t or
less

Yes

Notification: 10
times/FY
Declaration: As needed(renewal: 1 time/FY)

1,773 cases

Molar weight, physical andchemical stability test data,
etc.

No

No

As needed

45 cases

How to handle, drawing thatshows facilities andequipment.

No

No

As needed

132 cases(Simplified)1 t orless / 1
companyNo

As needed

189 cases

11

CSCL Screening /Risk Assessment* As of May 2018

Risk Assessment by Phase
CSCL Inventory

About 28,000

About 20,000 existing chemical substances
Approximately 8,000 new chemical substances
examined

About 12,000With more than 1t/year per company, notificationof manufacture/import volume and simple use

Reported Chemical Substances
Screening Assessment

14 Substances
Cancelled* Not including thecancellation of 8
intrusive substances

Priority Assessment Chemical
Substance Designation

Target Substances: approx. 8,000

208

Target: National manufacture/import
total volume above 10 tons/year

Judgment using priority matrix based on
hazard/exposure class

Risk Assessment(primary)
Assessment I

Target substances: 59 substances(Assessment II already
implemented)
9 human health effects
18 ecological effects

5 substances
cancelled

Assessment II

Assessment III

2 substance

Detailed evaluation using PRTR informationand monitoring in addition to
manufacturing/import volume and detailed
use information

Determine exposure information by requesting
handling information, additional monitoring, etc.

Instructions on hazardous investigation of long-term toxicity

Risk Assessment(secondary)Class II Specified Chemical
Substance

0 Substances

Examining hazard information

0 Substances(Former System: 23)

12

Status of Risk Assessment (Primary) Assessment II
for Priority Assessment Chemical Substances
The Risk Assessment (Primary) Assessment II for Priority Assessment Chemical Substances was
implemented on 3 substances in 2014, 7 in 2015, 9 in 2016 and 7 in 2017*1: a total of 26 substances (9substances on human health impact, 18 substances on ecological impact*2) to date.
Based on the past assessment results designations of Priority Assessment Chemical Substances werecancelled on 5 substances.
*1 In addition, assessments of hazardous properties were discussed on 2 substances. *2 Including substances on which the progress with risk assessment was reported.

Date ofevaluation
reportdeliberation
June 25,
2017

Name of Substance

Assessment
Viewpoint

Assessment Results (outline)

Future action

Ecology- There is no exposure assessment results that give sufficient grounds for a decision on
Assessment II.
- Collect data on actual measurements of isocyanuric acid through environment
monitoring in the future.

Assessment
II to continue

Ecology- There is no exposure assessment results that give sufficient grounds for a decision on
Assessment II.
Assessment- Collect data on actual measurements of decan-1-ol through environment monitoring in II to continue
the future.

Fenobucarb

Ecology- There is no exposure assessment results that give sufficient grounds for a decision on
Assessment II.
Assessment- Collect data on actual measurements of fenobucarb through environment monitoring in II
the future.

N,N-dimethylformamide

Human
Health- On the basis of PRTR information, inform business operators with the most significant
discharge amounts of their risk assessment results and encourage them to makevoluntary efforts. After checking for improvement with their discharge conditions,cancel their priority.

Cancelled
after efforts
areconfirmed

Ethylene oxide

Human
Health- Proceed to Assessment III to verify conditions with the many spots where hazardous
property values exceeded the evaluation values but no PRTR registered businessfacilities can be identified around the area concerned.
- Check how it is being handled in terms of laws and regulations.

Assessment
III tocontinue

Dichloroisocyanuric acid（to bereassessed after totaled withtrichloroisocyanuric acid)

Ecology- Examine chronic toxicity to fish.
- Collect data on actual measurements of isocyanuric acid through environment
monitoring in the future.

Assessment
II to continue

Ecology- Analyze factors contributing to uncertainty (e.g. setting of physicochemical properties,
setting of discharge amount) and examine them, starting with items that can mosteffectively reduce uncertainty.

Assessment
II to continue

Trichloroisocyanuric acid

November 24,
2017
Decan-1-ol

January 18,
2018

March 23,
2018

Amine oxides

13

③ Revision of CSCL

Emission factor for Exemption Rule of small or low
volume New Chemical Substances
Criteria for Specific New Chemical Substances

14

Evaluation System for New Chemical Substances (Current System)
1: Regular Evaluation System Anyone intending to manufacture or import new chemical substances shall notify the government inadvance.
 The government evaluates the properties of the newly notified chemical substance (degradability,
accumulation, whether it is toxic to human health/ecology) and regulates according to the results.
Test Items for the CSCL Regular Evaluation System(1) Info related to degradability(2) Info related to accumulativeness (3) Effect on Human Health(4) Ecological Effect

Does substance degrade in naturalenvironment?

Does substance accumulate easily if itenters body of organism?

Is substance toxic to livingorganisms?

Is substance toxic to humans?

CO2
H2 O

2: Exemption Rule for small or low volume new chemical substances In regards to new chemical substances whose manufacturing/import volume is below a specific amount,
and as a special measure, some or all of the above-mentioned evaluations will be exempt, andmanufacturing and importing can be carried out after confirming the volume.
 A similar special evaluation exception scheme exists in Europe and the United States, but due to theexistence of original domestic gross amount regulations in Japan, adjustment of the confirmation volume
by the government may occasionally take place.
Hazardous Items Requiring Evaluation
Small Volumes New Chemical
Substances

None

Low Volumes New Chemical
Substances

Degradability/Accumulativeness(No Toxicity Required)Individual Company’s
Maximum Volume
1 ton(Manufacture/
Import Amount)
10 tons(Manufacture/
Import Amount)

Nationwide Maximum
Volume1 ton(Manufacture/
Import Amount)
10 tons(Manufacture/
Import Amount)

15

Proposed Review of the Exemption Rule
 Utilize the "emission factor" for individual usage, and review it as a more rational regulatory system on the premise of ensuringsafety.
 Specifically, change the domestic gross amount regulation of the special evaluation exemption scheme from the
manufacture/import volume to environmental emissions (manufacture/import volume multiplied by the emission factor forindividual usage).
 Entry in force: January 1, 2019

Before Change: Domestic Gross System(Manufactured/Imported Volume) New Chemical Substance A 1 ton (planned volume/manufacture) 333kg (after confirming volume/manufacture)

After Change: Domestic Gross System(Environmental Emissions) New Chemical Substance A 1 ton (planned volume/manufacture) Use: electrical and electronic materials
 1 ton (after confirming volume/manufacture)

Manufacture/Import Volume
Environmental
Emissions Amount New Chemical Substance A 1 ton (planned volume/manufacture) 333kg (after confirming volume/manufacture) New Chemical Substance A 1 ton (planned volume/manufacture) 333kg (after confirming volume/
manufacture)<Expected Result> New Chemical Substance A 1 ton (planned volume/manufacture) Use: electrical and electronic materials
 1 ton (after confirming volume/manufacture) New Chemical Substance A 1 ton (planned volume/manufacture) Use: electrical and electronic materials
 1 ton (after confirming volume/manufacture)- With an emission factor of 0.0012 for electric and electronic materials thevolume of production is 1 ton, the environmental discharge amounts to 1.2
kg, and the total discharge of the three companies is 3.6 kg, so there is noneed to adjust the quantity.

 Utilizing emission factors that take into account its use, the volume adjustment will decrease, and the
production and import volume would increase.
 The uncertainty due to volume adjustment is eliminated, and business predictability will improve.

16

Emission Factor for Exemption Rule for small and low volume(draft)Emission factor for Exemption Rule for small and low
volumeUse Number(#)
101

Use Classification
Total

Intermediate material

Manufacturing
Long-termphase –
usage phaseusage phase

Disposal
phase

0.004

0.004

0

0

0.9

0.9

0

0.001

Paint, varnish, coating agent, ink, copying, biocide solvent
102
103

Bonding agent, adhesive agent, sealing material solvent

0.9

0.9

0

0.0007

104

Metal cleaning solvent

0.8

0.8

0

0.001

105

Cleaning washing solvent

0.8

0.8

0

0.002

106

Other washing solvents

0.8

0.8

0

0.002

107

industrial solvent

0.4

0.4

0

0.006

108

Aerosol solvent, physical foaming agent

1

1

0

0

109

Other solvents

1

1

0

0

110

Chemical process regulator

0.02

0.008

0

0.01

111

Colorant (dye, pigment, coloring matter, coloring material)

0.01

0.002

0.000040.01

112

Water-based detergent 1

0.07

0.06

0

0.009

113

Water-based detergent 2

1

1

0

0

114

Wax (for floors, vehicles, leather, etc.)

1

1

0

0

115

Paint, coating agent

0.01

0.01

0

0.004

116

Ink, copying chemical (toner, etc.)

0.1

0.01

0

0.09
17

Emission Factor for Exemption Rule for small and low volume(draft)Emission factor for Exemption Rule for Small and
Low Volume

Use Number(#)

Use Classification
Total

Manufacturing
Long-termphase –
usage phaseusage phase

Disposal
phase

121

Anti-fouling agent for ship bottom paint, anti-fouling agent forfishing nets
Biocide 1[ones that are contained in and shipped as part of a molded
product]
Biocide 2[ones that are used in a manufacturing process and notcontained in molded products]<<industrial use>>
Biocide 3<<household use, professional use>>
Powders, chemical foaming agent, solid fuel122

Air freshener, deodorizer

123

Bonding agent, adhesive agent, sealing material

0.02

0.01

0

0.01

124

Resist material, photographic material, printing plate material

0.05

0.04

0

0.01

125

Synthetic fabric, fiber treating agent

0.2

0.1

0.09

0.03

126

Paper/pulp chemical

0.1

0.01

0

0.09

127

Plastic, plastic additive, plastic processing aid

0.03

0.009

0.003

0.01

128

Synthetic rubber, rubber additive, rubber processing aid

0.06

0.005

0.04

0.02

129

Leather treating agent

0.02

0.01

0

0.01

130

Glass, enamel, cement

0.03

0.01

0

0.02

131

Ceramic ware, refractories, fine ceramics

0.1

0.04

0

0.06

132

Grinding stones, abrading agent, friction agent, solid lubricant

0.1

0.07

0

0.07

117
118

119

120

0.9

0.005

0.9

0.00090.04

0.03

0.0007

0.008

0.2

0.2

0

0.009

0.4

0.4

0

0.01

0.02

0.02

0

0

1

1

0

0

18

Emission Factor for Exemption Rule for small and low volume(draft)Emission factor for Exemption Rule for Small and
Low Volume

Use Number(#)

Use Classification
Total

Manufacturing
Long-termphase –
usage phaseusage phase

Disposal
phase

133

Metal manufacturing/processing material

0.1

0.1

0

0.02

134

Surface treatment agent

0.1

0.07

0

0.05

135

Welding material, soldering material, sealing and cutting
material

0.03

0.01

0

0.02

136

Hydraulic oil, insulating oil, lubricating oil (engine oil, bearingoil, compressor oil, grease, etc.)

0.02

0.009

0

0.007

137

Metal processing oil, Anti-rust oil

0.03

0.02

0

0.007

138

Electric/electronic material

0.01

0.006

0

0.007

139

Battery material (primary cell, secondary cell)

0.03

0.005

0

0.03

140

Water treatment agent

0.05

0.03

0

0.02

141

Drying agent, adsorptive agent

0.09

0.08

0

0.009

142

Heat medium

0.08

0.07

0

0.01

143

Anti-freezing solution

0.08

0.07

0

0.007

144

Construction material, construction material additive substance

0.3

0.3

0

0.03

145

Atomizing agent, landfill pre-treatment chemical (snow melting
agent, soil conditioner, extinguishing agent, etc.)

1

1

0

0

146

Separation and refinement processing agent

0.1

0.1

0

0.009

147

Fuel, fuel additive

0.004

0.004

0

0

199

For export

0.001

0.001

0

0

19

Necessity to review Chemical Substance Management regarding high toxicity
 In recent years, and in regard to the new chemical substances review,occasionally, there are chemical substances that pose a serious risk whenreleased into the environment due to high toxicity to human health and thehabitat of animals and plants, while emissions are extremely small.

 However, even with such chemical substances, if emission to theenvironment is small, it does not correspond to the Priority Assessment
Chemical Substances to which certain regulatory measures are imposed,
and as a general chemical substance, there is only a notification obligation
for the manufacture/import volume, making it impossible to take sufficientmeasures under the current CSCL.

 It is therefore necessary to take measures to encourage businesses tohandle appropriate chemical substances that are highly toxic in thereby
avoiding any accidental discharge.
20

Proposed Review of Chemical Substances with High Toxicity
In order to call attention to businesses dealing with highly toxic chemical substances, we will establish
jurisdiction, such as the obligation of business operators to communicate information, and provide national
guidance and advice to business operators.
* To be enforced from: April 1, 2018

<Image Diagram>
Notification
Notify the business operator about
the highly toxic chemical substance

Duty to Communicate Info
Reporting Business Operator+
Administration

Duty to communicate the info that it is ahighly toxic chemical substance

Property
Info,
etc.

Primary Downstream Operator+

Property
Info,
etc.

Guidance & Advice

Report on Handling Info
The minister in charge may
request any business operator
handling highly toxic chemical
substances to report on thehandling situation.
* For example, a business operator handling ahighly toxic chemical substance should keep
records on the state of delivery and stock status of
the chemical substance in advance, in the form ofa document, and for a certain period of time, sothat it can respond when asked for reports.

Secondary Downstream Operator+
3rd Downstream Operator

Property
Info,
etc.

Guidance and advice on thehandling method for highly toxic
chemical substances, according to
the actual situation of thebusiness concerned* For example, in order to prevent any
environmental pollution instructions and advice
are provided with information such as
improvement measures for the management
method along the supply chain.

21

Judgment Criteria for Specific New Chemical Substances

When a chemical substance is so highly toxic that once discharged into the environment, andeven if only in very small quantities, it will be continuously taken in by humans, etc. in and aroundthe discharged area and may cause damage to human health and the flora and fauna in humanliving environments. The specific new chemical substances scheme is intended to advise
business operators on the handling of such substances appropriately so that they will not be
accidentally discharged into the environment.
Judgment criteria for specific new chemical substances was made available to the public in April
13, 2018.

Judgment Criteria for Specific New Chemical Substances••

Any substance that meets any of the following conditions is considered to be a specific newchemical substance.
Toxicity to human health Any of the toxic property assessment values derived from the following tests being
0.0005mg/kg/day or less: (1) Bacterial reverse mutation test (2) Chromosome aberration test
using mammalian cultivated cells or mouse lymphoma TK test (3) Repeated dose 28-day
toxicity study, repeated dose 90-day toxicity study or combined repeated dose toxicity study
with reproduction/developmental toxicity test in mammals (4) reproductive anddevelopmental toxicity studies
 Either of the following tests shows highly positive results while the other one positive
abnormality: (1) Bacterial reverse mutation test (2) Chromosome aberration test using
mammalian cultivated cells or mouse lymphoma TK test
Ecotoxicity
 PNECs calculated in principle from the algae growth inhibition test, daphnia acuteimmobilization test, and fish acute toxicity test, being 3×10-4mg/L or less in three types ofchronic toxicity test, 3×10-5mg/L or less in two types of chronic toxicity test and one type ofacute toxicity test, or 3×10-5mg/L or less in one type of chronic toxicity test and two types ofacute toxicity test.
22