MEP Revised the Data Requirements under Guidance Documents for New Chemical Substance Notification in China

Tonnage (ton/year)

Data endpoint

Current requirements

Requirements after revision

1-10

Acute oral, dermal and inhalation toxicity

The acute oral, dermal and inhalation toxicity shall be submitted;

Only the data for one of the three exposure ways is required based on the purpose of notification.

AMES and in vitro chromosome aberration

Submit at the same time

Only the result of AMES testing should be submitted; when the result is positive and the substance will be widespread used, then data for the higher tonnage level (10-100 tonnes/ year) is required.

Repeated dose 28-day toxicity study

Shall be submitted.

Deleted

10-100

AMES, in vitro chromosome aberration and in vivo chromosome aberration

Submit at the same time

Results of AMES and in vitro chromosome aberration testing should be submitted at first; based on the results of the above two tests , the other tests (such as in vitro gene mutation testing, in vivo gene mutation testing and in vivo chromosome aberration testing) will be carried out or not.

Repeated dose 90-day toxicity study

Required when severely damages were observed in the repeated dose 28-day toxicity study

Deleted

Reproduction/ Development screening test

Shall be submitted

Could be replaced by the extended one-generation reproduction toxicity data.

Toxic kinetics

Submit relevant information of absorption of toxic kinedtcs.

Evaluate based on the existing information.

14 days extended toxicity study in fish

Shall be submitted

Deleted

100-1000

AMES, in vitro chromosome aberration and in vivo chromosome aberration

Submit at the same time

Same as the requirements for the 10-100 tonnage level

Two-generation reproduction toxicity

Shall be submitted

Could be replaced by the extended one-generation reproduction toxicity data

Toxic kinetics

Submit complete toxic kinetics data

Same as the requirements for the 10-100 tonnage level

1000+

AMES, in vitro chromosome aberration and in vivo chromosome aberration

Submit at the same time

Same as the requirements for the 10-100 tonnage level

Two-generation reproduction toxicity

Should be submitted

Could be replaced by the extended one-generation reproduction toxicity data

Toxic kinetics

Submit complete toxic kinetics data

Same as the requirements for the 10-100 tonnage level

Carcinogenicity

Shall be submitted

Whether to submit the testing data or the evaluation report is based on the mutagenicity classification and the possibility of exposure.

Chronic toxicity test in fish

Data for one of the following three tests is required: Fish, Early-life Stage Toxicity Test, Fish, Short-term Toxicity Test on Embryo and sac-fry Stages and Fish, Juvenile Growth Test

Only the result of fish juvenile growth test should be submitted

Earthworm reproduction test

Not required

Require submission when it is classified as terrestrial organism acute toxicity

End point

Requirements of current guidance

Requirements after adjustment

Autoignition temperature

Nonflammable liquid in the atmosphere;

Add the explanation of “E.g. flash point > 200 ℃ ”;

Melting point <160 ℃ , or the solid only with the self-heating when test temperature was up to 400 ℃ in preliminary testing;

Melting point ≤160 ℃ , or the solid without self-heating when test temperature was up to 400 ℃ in preliminary testing;;

Oxidability

Impossible to generate exothermic reaction with inflammable substance;

Add the explanation of “E.g. substance based on chemical structure (such as organism without oxygen or halogen atom, or these elements are not chemical bonding with nitrogen or oxygen, or the inorganics without oxygen or halogen atom);

For solid, if its oxidability showed clearly in preliminary trail, the full trail is not demanded;

Deleted

Skin corrosion/ irritation

Acute dermal toxicity is highly toxic;

Acute dermal toxicity category 1;

Eye irritation

Moderate skin irritation toxicity (and above); skin corrosion

Skin irritation category 2 (and above) or skin corrosion;

Mutagenicity

——

Add “If the in vivo genotoxicity test has already been tested, the in vitro genotoxicity test with same end point can be exempted”.

Acute inhalation/ Repeated dose inhalation toxicity for 28 days

The vapour pressure of substance <10 -2 Pa in 20 ℃ ;

The vapour pressure of liquid <10 -1 Pa in 20 ℃ ;

——

Explain the size of inhalable particles in particle size distribution is grain diameter ＜ 10μm ;

Acute dermal toxicity/Acute inhalation/ Repeated dose dermal toxicity for 28 days

——

Add “skin corrosion”;

Repeated dose oral toxicity for 28 days

——

Add reliable “Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test”;

Repeated dose toxicity for 90 days

——

Add “the result of repeated dose toxicity test for 28 days with same tested animal and exposure route indicates the toxic effect is observed or “No-observed-adverse-effect level

(NOAEL) is low and give the guideline values;

——

Add “cancerogenic substance category 1 or category 2”;

Chronic toxicity

- NOAEL of repeated dose toxicity is high;

- Not classified as Specific target organ toxicity (repeated) ；

- NOAEL of repeated dose toxicity is high (e.g. NOAEL of 90-day systemic toxicity≥300mg/kg), but except the situation that some toxic effect caused by the specific molecular structure is hard to be detected in 90-day repeated dose toxicity test and the substance have potential of hazard which cannot be detected by 90-day repeated dose toxicity test;

- Available toxic kinetics data could illustrate the chronic toxicity of substance;

- Combined Chronic Toxicity/ Carcinogenicity study 。

carcinogenicity

Germ cell mutagenicity or reproductive toxicity (regard as of germ cell Mutagenicity, carcinogenicity and reproductive/ developmental toxicity);

- Substance is classified as germ cell mutagenicity Category 1A or 1B;

- Completed the Combined Chronic Toxicity/Carcinogenicity Study.

Daphnia and fish acute toxicity

Has long-term toxicity test data with the same test species;

Has long-term toxicity test data with the same species (contains available acute toxicity data);

Terrestrial organism toxicity

Low soil absorption;

Low soil absorption, logKoc<1.5 ；

Activated sludge respiration inhibition

Information indicates that microorganism toxicity cannot be generated, e.g. extreme low water solubility;

Information indicates that microorganism toxicity cannot be generated, e.g. the result of soil microorganisms- nitrogen/ carbon transformation test is non-toxic.

Absorption/ Desorption

Substance and its degradation products decompose rapidly;

Substance and its degradation products decompose rapidly, e.g. hydrolysis half-life <12h;