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REACH

以下の一覧表はANNEX(付属書)Ⅶ~Ⅹにおける総量(単年換算:単位トン)に応じて、登録の際に必要となる試験/分析項目を記載しております。

1-10t (新規物質およびCMRが予見される物質)

物理化学的症状に関する情報

 項 目 明 細 ガイドライン
 20℃及び101.3kPaにおける物質状態 / state of the substance at 20℃ and 101.3kPa    
 融点 / melting point   OECD 102
EU A.1
 沸点 / boiling point   OECD 103
EU A.2
 相対密度 / relative density liquids OECD 109
EU A.3 
solids
 蒸気圧 / vapour pressure liquids - dynamic method OECD 104
EU A.4
solids - effusion method
  表面張力 / surface tension   OECD 115
EU A.5
  水中溶解度 / water solubility at on pH and one temperature frask method OECD 105
EU A.6
colume method
 分配係数 n-オクタノール/水 / partition coefficient N-Octanol / water frask method, at one pH OECD 107 EU A.8
HPLC method, at one pH OECD 117 EU A.8
 引火点 / flash point (liquids)   EU A.9
 可燃性 / flammability (solids)  full test UN-test N.1
or EU A.10 
if limit to pre test only
 爆発性 / explosive properties   full test EU A.14  
if limit to pre test only
expert statement
 自然発火温度 / self-ignition temperature  liquids EU A.15
solids EU A.16
 酸化特性 (液体) / oxidising propertise (liquids)  full test EU A.21 
expert statement
 酸化特性 (固体) / oxidising propertise (solids)   full test UN-test O.1 or
EU A.17 
if limit to pre test only EU A.17
expert statement  
 粘度 (固体) / granulometry (solids) sieve analysis
laser deiffraction
CIPAC MT 170 or
equivalent method
CIPAC MT 187

ヒト健康への有害性(毒性学的情報)

 項 目 明 細 ガイドライン
 In vitro 皮膚腐食性:ヒト皮膚モデル試験
  / skin corrosion (in vitro)
human skin model EPIDERM
human skin model EPISKIN
OECD 431
 In vitro 皮膚刺激性:再生ヒト表皮試験
   / skin irritation (in vitro)
human skin model EPIDERM
 (Epi-200-SIT)
human skin model EPISKIN
OECD 439
 皮膚腐食性評価のためのin vitro 膜バリア試験
   / membrane barrier test (in vitro)
method for skin model corrosion
  -Corrositex(TM)
OECD 435
 眼腐食性および強度刺激性物質を同定するためのウシ角膜を用いる混濁度 
 および透過性試験/ eye corrosion (in vitro)
BCOP
histopathology & photo documentation
OECD 437
 眼腐食性 / eye corrosion HET CAM  
  眼刺激性 / eye irritation (in vitro) Epi Ocular  

 皮膚感作:局所リンパ節試験
  / skin sensitisation: local lymph node assay
pre-test for dose selection; pre dose OECD 429
3 dose groups, 1 control group; 5 mice pre group
each further group; 5 mice per group
3 dose groups, 1 control group; 5 mice pre group
additional assessment of lymph node weight
each further group; 5mice per group
additional assessment of lymph node weight
3 dose groups, 1 control group; 5 mice per group
additional assessment of ear thickness
each further group; 5mice per group
additional assessment of ear thickness
 皮膚感作性 / skin sensitisation
  / Magnusson/Kligman 
10/5 guinea pigs (test/control)
10/5/5 guinea pigs (test/control/control)
OECD 406
EU B.6
 Ames試験:細菌復帰突然変異試験
  / Salmonella Typhimurium reverse mutation test
standard version(4-6 week)
  -single experiment
independent repetition
OECD 471
OPPTS 870.5100
EU B.13/B.14
 急性経口毒性試験 / acute oral toxicity ATC, basic testing, initially 2 steps, 6 animals OECD 423
OPPTS 870.1000
and 870.1100
for any futher step (3 animals)
fixed dose procedure, sighting study OECD 423
OPPTS 870.1000
and 870.1100 
main study, 5 rats
up-and-down procedure, main study-base
Approx. 6 animals
OECD 423
OPPTS 870.1000
and 870.1100 
each further animal
histopathology og gross lesions,
depending on findings
 

環境影響(生態毒性学的情報)

 項 目 明 細 ガイドライン
 ミジンコ類急性遊泳阻害試験
   / acute toxicity to Daphnids                                                  .
static, incl. dose range finding
12 samples estimated for accompanying analytics
OECD 202
EU C.2
semi-static, incl. dose range finding
18 samples estimated for accompanying analytics
limit study - static
≧4 samples estimated for accompanying analytics
 藻類生長阻害試験
   / toxicity to Algae (Green Algae)
static, incl. dose range finding
12 samples estimated for accompanying analytics
OECD 201
EU C.3
limit study - static
≧4 samples estimated for accompanying analytics
  易分解性試験
   / ready biodegradability (closed bottle )
Full test OECD 301 D   .  
EU C.4-D 
COD determination (non-GLP)
 易分解性試験
   / ready biodegradability (manometric respirometry )
Full test OECD 301 F
EU C.4-F
COD determination (non-GLP)
determination of Nitrate and Nitrite (non-GLP)
 易分解性試験
   / ready biodegradability (CO2-evolution test)
full test, without COD-determination
(chemical oxygen demand)
and determination of C-content
OECD 301 B
EU C.4-B
C-determination (non-GLP)
生物学的分解性試験
   / inherent biodegradability
   / Zahn-Wellens-Test
  OECD 302 B

 

10-100t (1-10tにて要求される事項にプラスして)

物理化学的症状に関する情報

 項 目 明 細 ガイドライン
 加水分解 / abiotic degradability (Hydrolysis) preliminary test at pH4, 7, 9
and at 50℃ (Tier 1)
OECD 111
EU C.7
main test at one pH and two additional
temperatures (Tier 2)
identification of degradation products (Tier 3)
 吸収係数予測 / adsorption desorption screenin  . HPLC method OECD 121

ヒト健康への有害性(毒性学的情報)

 項 目 明 細 ガイドライン
 急性皮膚刺激性/腐食性皮膚腐食性
   / acute skin irritation/corrosion (in vivo)
3 rabbitts, 72h obsarvation period
each further observation day / animal
OECD 404
EU B.4
 急性眼刺激性/腐食性
    / acute eye irritation/corrosion (in vivo)
3 rabbitts, 72h obsarvation period
each further observation day / animal
OECD 405
OPPTS 870.2400
EU B.5 
 哺乳類細胞を用いたin vitro小核試験
    / micronucleus test in Chinese Hamster Cells (in vitro)
single experiment
independent repetition
OECD 487
 哺乳類細胞を用いたin vitro小核試験
    / micronucleus test in Human Lymphocytes (in vitro)
single experiment
independent repetition
OECD 487
 哺乳類のin vitro 染色体異常試験
    / chromosome aberration test in Chinese Hamster Cells
      (in vitro)
single experiment
independent repetition
OECD 473
OPPTS 870.5375
EU B.10
 哺乳類のin vitro 染色体異常試験
    / chromosome aberration test in Human Lymphocytes
      (in vitro)
single experiment
independent repetition
OECD 473
OPPTS 870.5375
 哺乳類細胞のin vitro 遺伝子突然変異試験
  / Mouse Lymphoma assay
single experiment
independent repetition
OECD 476
OPPTS 870.5300
EU B.17
 哺乳類細胞のin vitro 遺伝子突然変異試験
  / HPRT test
single experiment
independent repetition
OECD 476
OPPTS 870.5300
 急性吸入毒性試験 / acute inhalation toxicity limit study (1 exposure level)
incl. standard analytics (gravimetry)
OECD 403
OPPTS 870.1300
 急性経皮毒性試験 / acute dermal toxicity limit study
full study
OECD 402
OPPTS 870.1200
EU B.3
 急性経皮毒性試験験
  / acute dermal toxicity fixed dose procedure  
sighting study OECD 434 
main study (limit)
histopathology of gross lesions,
depending on findings
 
 げっ歯類における28 日間反復経口投与毒性試験
  / repeated dose oral toxicity 28day; Rat
dose range finding, 14days,
up to 4 dose groups - non-GLP
OECD 407
(3rd version, Oct 2008)
OPPTS 870.3050
dose range finding, extended version
includes biochemistry - non-GLP
limit test, 1 dose group, 1 control group
each sex
(13 samples estimated for accompanying
analytics)
full study, 3 dose group, 1 control group
each sex
(26-32 samples estimated for accompanying
analytics)
recovery satellite groups, 14days,
1 dose group, 1 control group each sex
 反復投与経皮毒性試験21 日または28 日試験
  / repeated dose dermal toxicity 28day; Rat   
dose range finding, 14days,
up to 4 dose groups - non-GLP
OECD 410
OPPTS 870.3200   
limit test, 1 dose group, 1 control group
each sex
(13 samples estimated for accompanying
analytics)
full study, 3 dose group, 1 control group
each sex
(26-32 samples estimated for accompanying
analytics)
recovery satellite proup, 14days, 1 dose group,
1 control group each sex
 亜急性吸入毒性28 日試験
  / repeated dose lnhalation toxicity 28day or 14day study
  OECD 412
 生殖/発生毒性スクリーニング試験
  / reproductive screening test - Rats 
dose range finding - non-GLP OECD 421
OPPTS 870.3550    
3 dose groups + 1 control, 10 animal/group/sex
(32 samples estimated for accompanying
analytics)
 反復投与毒性試験と生殖発生毒性スクリーニング試験の複合試験
  / combined repeated dose toxicity study with
   reproductive/devepolpmental toxicity screening test - Rats 
dose range finding - non-GLP OECD 422
OPPTS 870.3650     
3 dose groups + 1 control, 10 animal/group/sex
(32-40 samples estimated for accompanying
analytics)
 トキシコキネティクス
  / toxicokinetics 
repeated dose toxicokinetics in rat
oral application, 3 dose and 1 control group;
treatment period:28day, up to 8 timepoint for
blood collection
further study designs are available upon
request
(26-31 samples estimated for accompanying
analytics)
OECD 417
ECC B.36  
expert statement

環境影響(生態毒性学的情報)

 項 目 明 細 ガイドライン
 魚類急性毒性試験
    / acute toxicity to Fish
static incl. dose range finding
(12 samples estimated for accompanying
analytics)
OECD 203
EU C.1
semi-static incl. dose range finding
(30 samples estimated for accompanying
analytics)
limit study - static
(≧4 samples estimated for accompanying
analytics)
 活性汚泥呼吸阻害試験
    / activated sludge respiration inhibition test
total oxygen uptake OECD 209
EU C.11
nitrification and organic carbon oxidation
limit study (total oxygen uptake)

 

100-1000t (10-100tにて要求される事項にプラスして)

物理化学的症状に関する情報

 項 目 明 細 ガイドライン
 有機溶媒中の安定性および関連分解成分の同定
    / stability in Organic solvents and identity of relevant
     degradation product
                                    .  
 解離定数 / dissociation constant in water - UV method   OECD 112
 粘度測 / viscosity   OECD 474
CIPAC MT 192
 吸着脱着 / adsorption / desorption tier 1-2 (per soil)
tier 3 (per soil) 
OECD 106

ヒト健康への有害性(毒性学的情報)

 項 目 明 細 ガイドライン
 哺乳類赤血球小核試験
     / micronucleus test - Mouse peripheral blood cell
        (in vivo)
single experiment - standard version OECD 474
OPPTS 870.5395
single experiment (limit test)
bioanalytics
 哺乳類赤血球小核試験
     / micronucleus test - Haematopoietic bone marrow
        (in vivo)
single experiment - standard version OECD 474
OPPTS 870.5395
single experiment (limit test)
bioanalytics
 哺乳類骨髄染色体異常試験
      / chromosome aberration test Mouse (in vivo)
single experiment OECD 475
OPPTS 870.5385  
single experiment (limit test)
bioanalytics
 哺乳類骨髄染色体異常試験
      / chromosome aberration test Rat (in vivo
single experiment OECD 475
OPPTS 870.5385  
single experiment (limit test)
bioanalytics
 哺乳類肝細胞を用いるin vivo 不定期 DNA 合成(UDS)試験
      / unschedule DNA synthesis (UDS) test (in vivo)
single experiment OECD 486
OPPTS 870.5550   
single experiment (limit test)
 変異原性試験
  / comet assay (in vivo)
single experiment  
single experiment (limit test)
 哺乳類の精原細胞を用いる染色体異常試験
  / mammalian spermatogonial chromosome aberration test
  OECD 483
OPPTS 870.5380
 げっ歯類における90 日間反復経口投与毒性試験
  / repeated dose oral toxicity - 90day ; Rat      
dose range finding, up to 6 dose group
- non-GLP
OECD 403
OPPTS 870.3100 
dose range finding - extended version,
up to 6 dose groups - non-GLP
limit test, 1 dose group, 1 control group
each sex
(19 samples estimated for accompanying
analytics)
full study, 3 dose group, 1 control group
each sex
(38-49 samples estimated for accompanying
analytics)
recovery satellite groups, 4weeks, 1 dose group,
1 control group each sex
toxicokinetics (full study)
toxicokinetics (recovery sattellite groups)
 亜慢性経皮毒性90 日試験
  / repeated dose dermal toxicity - 90day; Rat
dose range finding, up to 6 dose groups
- non-GLP
OECD 411
OPPTS 870.3250
dose range finding, extended version,
up to 6 dose groups - non-GLP
full study, 3 dose group, 1 control group
each sex
(38-49 samples estimated for accompanying
analytics)
toxicokinetics (full study)
toxicokinetics (recovery sattellite groups)
 亜慢性吸入毒性:90 日試験
  / subchronic inhalation toxicity - 90day study
  OECD 411
OPPTS 870.3465
 出生前発生毒性試験(ラット)
  / prenatal developmental toxicity study - Rats  
dose range finding - non-GLP
visceral examination inculuding head section
(examination, sekletal examination)
OECD 414
OPPTS 870.3700
3 dose groups + 1 control, 100 females and 50 males
for all groups
(24-32 samples estimated for accompanying
analytics)
 出生前発生毒性試験(ウサギ)
  / prenatal developmental toxicity study - Rabbit
dose range finding - non-GLP OECD 414
OPPTS 870.3700
full study

環境影響(生態毒性学的情報)

 項 目 明 細 ガイドライン
 ミジンコ繁殖試験(21日間)
    / Daphnia reproduction test (21day) 
semi-static
(36 samples estimated for accompanying
analytics)
OECD 211
EU C.20
dose range finding (non-GLP)
 魚類延長毒性試験
    / long-term toxicity to Fish 
semi-static study 14days
(24 samples estimated for accompanying
analytics)
OECD 204 
semi-static study 28days
(48 samples estimated for accompanying
analytics)
 魚類の初期生活段階毒性試験
    / Fish early-life stage toxicity test
Zebra fish
(30 samples estimated for accompanying
analytics)
OECD 210
  魚類の胚・仔魚期における短期毒性試験
    / short-term toxicity test on Embryo and Sac-Fry stage for Fish 
Zebra fish
(30 samples estimated for accompanying
analytics)
OECD 212 
dose range finding (non-GLP)
  魚類稚魚成長毒性試験
    / juvenile growth test for Fish
Zebra fish
(30 samples estimated for accompanying
analytics)
OECD 215
 土壌中の好気的形態変化
    / aerobic transformation in 1 soil (Route)
  OECD 307
 土壌中の好気的形態変化
    / aerobic transformation in 3 soil (Rate)
  OECD 307
 土壌中の嫌気的形態変化
    / anaerobic transformation in 1 soil (Route)
  OECD 307
 水系底質系における好気的形態変化
    / aerobic transformation in 2 water/sediment systems
  OECD 308
 水系底質系における嫌気的形態変化
    / anaerobic transformation in 2 water/sediment systems
  OECD 308
 表層水中の好気的無機化作用-模擬生分解テスト
    / aerobic mineralisation in surface water
2 systems, radiolabelled test item OECD 309
 代謝物質の同定(分解成分)
    / identification of metabolites (degradation products)
   
 魚類における生物濃縮
    / bioaccumulation in Fish 
dose range finding (non-GLP) OECD 305
EU C.13 
main study (Zebra fish)
(number of samples for accompanying analytics
to be determined)
 ミミズ急性毒性試験
    / acute toxicity to earthworms 
main study incl. dose range finding OECD 207 
limit study
 土壌微生物窒素/炭素無機化試験
    / effects on soil microorganisms 
pre-test OECD 216/217
EU C.21 
main study
 陸生植物生長試験
    / terrestrial plant test: seeding emergence  
dose range finding OECD 208  
main study (Zebra fish)
(number of samples for accompanying analytics
to be determined)
limit test
 陸生植物活性試験
     / terrestrial plant test: vegetative vigour  
dose range finding OECD 227  
main study (Zebra fish)
(number of samples for accompanying analytics
to be determined)
limit test

 

>1000t (100-1000tにて要求される事項にプラスして)

ヒト健康への有害性(毒性学的情報)

 項 目 明 細 ガイドライン
 慢性毒性試験
      / 52-week oral toxicity study -Rats
3 dose groups + 1control, 10 animal/group/sex
(44 samples estimated for accompanying
 analytics)
OECD 452
 拡張一世代生殖毒性試験
      / extended one generation reproductive                            .
         toxicity study - Rats
3 dose groups + 1 control, 
25 females and 25 males per group
(66 samples estimated for accompanying
  analytics)
OECD 443
 二世代生殖毒性試験
      / two generation reproductinve toxicity study - Rats
3 dose groups + 1 control,
25 females and 25 males per group
(sperm analysis by Hamilton Thorn TOX IVOS)
(66-110 samples estimated for accompanying
 analytics)
OECD 416
OPPTS 870.3800 
 癌原性試験
      / carcinogenetic study in Mouse (78 weeks)
3 dose grousps + 1 control,
50 females and 50 males per group
OECD 451
OPPTS 870.4200 
 癌原性試験
      / carcinogenetic study in Mouse (2 - yaers)
3 dose grousps + 1 control,
50 females and 50 males per group
OECD 451
OPPTS 870.4200
 慢性毒性/癌原性組合せ試験
    / dietary combined chronic toxicity
      / carcinogenicity study in Wistar Rats
3 dose groups + 1 vehicle control grousp
each study part
(number od samples for accompanying
 analytics to be determined)
OECD 453

環境影響(生態毒性学的情報)

 項 目 明 細 ガイドライン
 ミミズ繁殖毒性試験
     / long-term toxicity to terrestrial invertebrates (Earthworm)
main study OECD 222
limit study
 陸生植物生長試験
     / terrestrial plant test: seeding emergence
dose range finding OECD 208
main study
(number of samples for accompanying
analytics to be determined)
limit test
 陸生植物活性試験
     / terrestrial plant test: vegetative vigour
dose range finding OECD 227
main study
(number of samples for accompanying
analytics to be determined)
limit test
 土壌中ユスリカ毒性試験
     / long-term toxicity to sediment organisms
(9 sediment samples
  estimated for accompanying analysis)
OECD 218
 水中ユスリカ毒性試験
     / long-term toxicity to sediment organisms
(18 water samples
  estimated for accompanying analysis)
OECD 219
 鳥類繁殖試験
     / avian reproduction stusy
  OECD 206

 

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