Data Exemption for Registration of New Chemical Substance of Intermediates

Release time:

2021-02-10 09:49

The data requirements for special substances in the "New Chemical Substances Environmental Management Registration Guidelines" stipulate that intermediates for three uses are not required to submit special requirements data for regular and simple registration. Although it seems that there are not many exemption data items, they have greatly increased the registration cycle and cost, especially for several health toxicology tests that are regular registered, and the test cost may exceed the sum of other tests. Today we will look at under what circumstances intermediates need to be registered, which intermediates can be exempted from some data, and which data are exempted.

Intermediates to be registered

Intermediate refers to the chemical substance that is chemically reacted in the previous step in the whole chemical reaction process, which is consumed in the next chemical reaction process and used to produce other chemical substances or products. Intermediates should not be present in manufactured chemicals or products, except as impurities. All intermediates were registered unless isolated.

The non-isolated intermediate refers to an intermediate that does not leave the reaction vessel or reaction device, and also includes the case where the intermediate is temporarily stored in the vessel after the reaction and used for the next chemical reaction in the same plant.

Intermediates to exempt partial data

For chemical substances used only as pesticide intermediates, pharmaceutical intermediates or veterinary drug intermediates, the minimum requirements data for health toxicology and ecotoxicology may be submitted only for basic data and no special requirements data need to be submitted.

The application for registration should be accompanied by detailed information confirming the use of the chemical substance for intermediates, such as production and use units, production and use processes, and information on the substance or product produced using the new chemical substance.

Exemption of intermediate data:

Intermediates belonging to the above three types are exempted from all special requirements data when submitting simple and regular registration. On the basis of the basic requirement data, 2 items of chronic ecotoxicology data are added for simple registration, 3 items of terrestrial ecotoxicology data and 3 items of health toxicology data are added for regular registration, and the specific requirements for repeated exposure and reproductive and developmental toxicity data are higher than the basic requirement data. The specific exempt data items are as follows:

simple registration	regular registration
Ecotoxicology	Ecotoxicology	Health Toxicology
Daphnia magna reproduction	Seed germination and root elongation/ terrestrial plant growth	toxicokinetics
chronic toxicity of fish	Line Worm Reproduction/ earthworm reproduction	chronic toxicity
	Benthic chronic toxicity	Carcinogenicity
		90 days repeated toxicity
		Reproductive/developmental toxicity *

*: The reproductive and developmental toxicity in the special requirements data may be submitted to developmental toxicity during pregnancy and/or two generations of reproductive toxicity, etc. according to the nature of the substance.

Intermediate data requirements:

Physical and Chemical Properties			Ecotoxicology	Health Toxicology
gaseous	Liquid	Solid State	Ecotoxicology	Health Toxicology
Spectrogram *	Spectrogram *	Spectrogram *	Algae growth inhibition toxicity *	acute toxicity
Water Solubility *	Melting Point *	Melting Point *	Daphnia acute toxicity *	Skin corrosion/irritation
Critical Point *	Boiling Point *	Density *	Fish Acute Toxicity *	Eye irritation
Henry's constant	Density *	Water Solubility *	Degradeability *	skin sensitization
	Vapor pressure *	n-Octanol/water partition coefficient *	Bioaccumulative *	mutagenicity
	Water Solubility *	particle size	Adsorption/desorption	28 days repeated toxicity
	n-Octanol/water partition coefficient *	dissociation constant	earthworm acute toxicity	Reproductive/Developmental Toxicity Screening
	pH *	Henry's constant	activated sludge respiration inhibition toxicity
	surface tension		Daphnia magna reproduction
	dissociation constant		chronic toxicity of fish
	Henry's constant

Note: The registration data in the form includes regular registration and simple registration. All data must be provided for regular registration, and simple registration provides data marked.

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