New Chemical Substance Notification-Odyssey Compliance Incorporation

New Chemical Substance Notification

NCSN Introduction

1 NCSN

In order to enhance the environmental management and control the environmental risk on new chemical substances, prevent environmental pollution, and protect human health and safeguard the ecological environment, MEP issue the “Provisions on the Environmental Administration of New Chemical substances”. According to the Provision, “new chemical substance” means any chemical substance which has not yet been listed in the Inventory of Existing Chemical Substances Manufactured or Imported in China (IECSC). Any manufacturer or importer of new chemical substances shall, prior to the manufacture or import of new chemical substances, make notifications and applications for the registration certificates for the environmental management on new chemical substances (hereinafter cited as ‘the registration certificates’) in compliance with this Provisions.

General Notification

Simple Notification

Scientific and Research Record Notification

(Ministry of Environmental Protection of the People’s Republic of China Statute No.7)

2 Solid Waste and Chemicals Management Technology Centre of MEE, SCC-MEE

Solid Waste and Chemicals Management Technology Centre of MEP was established in June 2013. It was formed by combining the former solid waste management center of MEP and the former Chemical Registration Center of MEP. Its name was changed to Solid Waste and Chemicals Management Technology Centre of MEE in May 2019. It is a bureau level institution directly under MEE. It is a technique supporting sub-institute for management of solid waste, chemicals, contaminated sites and heavy metal environment of MEE.

3 OCI NCSN Department and Team

OCI is one of the first companies to focus on new chemical substances notification (NCSN), and has accumulated rich experience.

In the actual operation of many years, the company has successfully established a sophisticated core technology team, covering all aspects of the business, able to give feedback to the customer's information in time, meeting the various needs of the customers from different angles, and attracting more and more attention in the rapid development of China and the petrochemical industry. OCI provides you with excellent new chemical substance notification service.

4 Advantages of OCI

The optimum experiment plan, the shortest processing time and the best results are from:

(1) Our professional team and long-term stable partner relationships with well-known laboratory at home and abroad

(2) The support of hygeian toxicology and ecotoxicology experts at home and abroad

(3) Close relationship with relevant authorities

(4) Abundant data resources

(5) The perfect commercial secrecy system

Services of NCSN

Items	Description
IECSC check	Public or confidential
Initial assessment	Assess the notification type via the usage, quantity and Sponsor
Notification plan	Base on the existing data, notification type and exposure information
Periodic report	Update by month or quarter
Translating reports	Review the acceptability
Translating reports	Translating the summary
Arranging the tests	Different price level labs for choice
	Contract with the selected lab
	Update by month or quarter
	Review the test results
	Send the test results to the Sponsor
Test waiver	Base on the existing data, usage and exposure information
Risk assessing report	Propose the control measures via the physicochemical, toxicity and eco-toxicity data, usage and exposure information,
Notification dossiers	Preparing the test data
	Compiling the environmental risk assessing report
	Compiling or translating MSDS, GHS labels
	Submitting the dossiers
MSDS, GHS labels	Based on the existing data and original version, in compliance with Chinese regulations

NCSN Tests

OECD No.	Chinese Name	English Name
Section 1 Physis-Chemical Properties
101	紫外可见吸收光谱	UV-VIS Absorption Spectra
101	分光光度法	Spectrophotometric Spectra
102	熔点/熔点范围	Melting Point/Melting Range
103	沸点	Boiling Point
104	蒸汽压	Vapour Pressure
105	水溶解度	Water Solubility
106	吸附/解吸	Adsorption/Desorption
107	分配系数（正辛醇/水）－摇瓶法	Partition Coefficient (n-octanol/water)-Shake Flask Method
108	在水中形成配位化合物的能力－极谱法	Complex Formation Ability in Water-Polarographic Method
109	液体和固体的密度	Density of Liquids and Solids
110	颗粒物粒度分布/纤维长度和直径分布	Particle Size Distribution/Fibre Length and Diameter Distributions
111	与pH有关的水解作用	Hydrolysis as a Function of pH
112	在水中的离解常数	Dissociation Constants in Water
113	热稳定性和空气中稳定性的筛选试验	Screening Test for Thermal Stability and Stability in Air
114	液体的粘度	Viscosity of Liquids
115	水溶液的表面张力	Surface Tension of Aqueous Solution
116	固态和液态物质的脂溶性－烧瓶法	Fat Solubility of Solid and Liquid Substances-Flask Method
117	分配系数（正辛醇/水）－高效液相色谱法	Partition(n-octanol/water),High Performance Liquid Chromatography(HPLC)Method
118	凝胶渗透色谱法（GPC）测定聚合物的数均分子量及分子量分布	Determination of the Number Average Molecular Weight and the Molecular Weight Distribution of Polymers Using Gel Permeation Chromatography
119	凝胶渗透色谱法（GPC）测定聚合物低分子量部分的含量	Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation Chromatography
120	聚合物在水中的溶解/萃取行为	Solution/Extraction Behaviour of Polymers in Water

Section 2 Effects on Biotic Systems
201	藻类生长抑制试验	Alga Growth Inhibition Test
202	溞类24h EC50急性活动抑制试验	Daphnia sp.24h EC50 Acute Immobilization Test
203	鱼类急性毒性试验	Fish Acute toxicity Test
204	鱼类14天延长毒性试验	Fish, Prolonged Toxicity Test:14-day Study
205	鸟类日粮毒性试验	Avian Dietary Toxicity Test
206	鸟类繁殖试验	Avian Reproduction Test
207	蚯蚓急性毒性试验	Earthworm, Acute Toxicity Test
208	陆生植物生长试验	Terrestrial Plants, Growth Test
209	活性污泥呼吸抑制试验	Activated Sludge, Respiration Inhibition Test
210	鱼类早期生活阶段毒性试验	Fish, Early-life Stage Toxicity Test
211	大型溞繁殖试验	Daphnia magna Reproduction Test
212	鱼类胚胎-卵黄囊吸收阶段的短期毒性试验	Fish, Short-term Toxicity Test on Embryo and sac-fry Stages
213	蜜蜂急性经口毒性试验	Honeybees, Acute Oral Toxicity Test
214	蜜蜂急性接触毒性试验	Honeybees, Acute Contact Toxicity Test
215	鱼类幼体生长试验	Fish, Juvenile Growth Test
216	土壤微生物：氮转化测试	Soil Microorganisms: Nitrogen Transformation Test
217	土壤微生物：碳转化测试	Soil Microorganisms: Carbon Transformation Test
299	种子发芽和根伸长毒性试验	Seed Germination/Root Elongation Toxicity Test

Section 3 Degradation and Accumulation
301	快速生物降解性		Ready Biodegradability
301	301A	DOC消减试验	DOC Die-Away Test
	301B	CO2产生试验	CO2 Evolution Test
	301C	改进的MITI试验（I）	Modified MITI Test I
	301D	密闭瓶试验	Closed Bottle Test
	301E	改进的OECD筛选试验	Modified OECD Screening Test
	301F	呼吸计量法试验	Manomettric Respiremetry Test
302	302A	改进的半连续活性污泥（SCAS）试验	Inherent Biodegradability: Modified SCAS Test
	302B	赞恩-惠伦斯试验	Zahn-Wellens Test
	302C	改进的MITI试验（II）	Inherent Biodegradability: Modified MITI Test II
303A	模拟试验—好氧污水处理：偶联单元试验		Simulation Test-Aerobic Sewage Treatment: Coupled Units Tests
304A	土壤固有生物降解能力		Inherent Biodegradability in Soil
305	流水式鱼类试验		Bioconcentration: Flow-Through Fish Test
305	305A	连续静态鱼类试验	Bioconcentration: Sequential Static Fish Test
	305B	半静态鱼类试验	Bioconcentration: Semi-Static Fish Test
	305C	鱼类生物富集试验	Bioconcentration: Test for the Degree of Bioconcentration in Fish
	305D	静态鱼类试验	Bioconcentration: Static Fish Test
399	吸收和蓄积试验		Update and Accumulation Test

Section 4 Health Effects
401	急性经口毒性试验	Acute Oral Toxicity Test
402	急性经皮毒性试验	Acute Dermal Toxicity Test
403	急性吸入毒性试验	Acute Inhalation Toxicity Test
404	急性皮肤刺激性/腐蚀性试验	Acute Dermal Irritation/Corrosion Test
405	急性眼刺激性/腐蚀性试验	Acute Eye Irritation/Corrosion Test
406	皮肤致敏试验	Skin Sensitization Test
407	啮齿类动物28天反复经口毒性试验	Repeated Dose 28-day Oral Toxicity Study in Rodents
408	啮齿类动物亚慢性（90天）经口毒性试验	Repeated Dose 90-day Oral Toxicity Study in Rodents
409	非啮齿类动物亚慢性（90天）经口毒性试验	Repeated Dose 90-day Oral Toxicity Study in Nonrodents
410	反复经皮毒性：21/28天试验	Repeated Dose Dermal Toxicity:21/28-day Study
411	亚慢性经皮毒性：90天试验	Subchronic Dermal Toxicity:90-day Study
412	反复吸入毒性：28天或14天试验	Repeated Dose Inhalation Toxicity:28/14-day Study
413	亚慢性吸入毒性：90天试验	Subchronic Inhalation Toxicity:90-day Study
414	致畸试验	Teratogenicity
415	一代繁殖毒性试验	One-Generation Reproduction Toxicity Study
416	两代繁殖毒性试验	Two-Generation Reproduction Toxicity Study
417	毒代动力学试验	Toxicokinetics Study
418	有机磷化合物急性染毒的迟发性神经毒性试验	Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure
419	有机磷化合物亚慢性（28天）染毒的迟发性神经毒性试验	Delayed Neurotoxicity of Organophosphorus Substances:28-Day Repeated Dose Study
420	急性经口毒性：固定剂量法	Acute Oral Toxicity-Fixed Dose Method
421	生殖和发育毒性筛选试验	Reproduction/Developmental Toxicity Screening Test
422	结合反复染毒毒性研究的生殖发育毒性筛选试验	Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
423	急性经口毒性：急性毒性的阶层法	Acute Oral Toxicity-Acute Toxic Class Method
424	啮齿类动物的神经毒性试验	Neurotoxicity Study in Rodents
425	急性经口毒性：上下增减剂量法	Acute Oral Toxicity-Up and Down Procedure
451	致癌试验	Carcinogenicity Studies
452	慢性毒性试验	Chronic Toxicity Studies
453	慢性毒性与致癌性联合试验	Combined Chronic Toxicity/Carcinogenicity Studies
471/472	细菌回复突变试验	Bacterial Reverse Mutation Test
473	体外哺乳动物细胞染色体畸变试验	In vitro Mammalian Chromosome Aberration Test
474	哺乳动物红细胞微核试验	Mammalian Erythocyte Micronucleus Test
475	哺乳动物骨髓染色体畸变试验	Mammalian Bone Marrow Chromosome Aberration Test
476	体外哺乳动物细胞基因突变试验	In vitro Mammalian Cell Gene Mutation Test
477	黑腹果蝇伴性隐性致死试验	Sex-linked Recessive Lethal Test in Drosophila Melanogaster, SLRL
478	啮齿类动物显性致死试验	Rodent Dominant Lethal Test
479	哺乳类动物细胞姐妹染色单体互换体外试验	In vitro Sister Chromatid Exchange Assay in Mammalian Cells
480	酿酒酵母基因突变试验	Saccharomyces cerevisiae, Gene Mutation Assay
481	酿酒酵母有丝分裂重组试验	Saccharomyces cerevisiae Mitotic Recombination Assay
482	哺乳类动物细胞DNA损害与修复/程序外DNA合成体外试验	DNA Damage and Repair/Unscheduled DNA Synthesis in Mammalian Cells in vitro
483	哺乳动物精原细胞染色体畸变试验	Mammalian Spermatogonial Chromosome Aberration Test
484	小鼠斑点试验	Mouse Spot Test
485	小鼠可遗传易位试验	Mouse Heritable Translocation Assay
486	体外哺乳动物肝细胞程序外DNA合成（UDS）试验	Unscheduled DNA Synthesis (UDS)Test with Mammalian Liver Cells in vitro
490	空斑形成细胞试验	Plaque Forming Cell Assay
491	迟发性超敏反应试验	Delayed Type Hypersensitivity Test
492	自然杀伤细胞活性试验	Natural Killer Cell Activity Assay