Superseding
Chinese Name	��ѧƷ���ࡢ��ʾ��ǩ�;�ʾ��˵����ȫ�淶 ��ֳ����
English Name
Chinese Standard Classification
Professional Classification
ICS Classification
Issued on	2006-10-24
Implemented on	2008-01-01
Abolished on
Issued by	AQSIQ, SAC
Chinese Pages
Word Count	7000 words

1  Scope

This standard specifies terms and definitions, classification, judgment flow, category and precautionary labelling, arrangement of category and label elements and general requirements for precautionary statements of reproductive toxicity caused by chemicals.
This standard is applicable to hazards classification, precautionary labelling and precautionary statements of reproductive toxicity caused by chemicals in accordance with the United Nations "Globally Harmonized System of Classification and Labeling of Chemicals".


2  Normative References

The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of these documents is applicable. For undated references, the latest edition of the normative document is applicable to this standard.
GB 20596-2006 "Safety Rules for Classification, Precautionary Labelling and Precautionary Statements of Chemicals-Germ Cell Mutagenicity"
"UN Globally Harmonized System of Classification and Labeling of Chemicals" (GHS)
"UN Recommendations on the Transport of Dangerous Goods-Manual of Tests and Criteria" (Fourth revised edition) (TDG/MR)
"UN Recommendations on the Transport of Dangerous Goods-Model Regulation"
ICH Guideline S5A, 1993
ICH Guidance S5B, 1995
OECD Test Guideline 414-Teratogenesis Test
OECD Test Guideline 415-One-generation Reproductive Toxicity Test
OECD Test Guideline 416-Two-generation Reproductive Toxicity Test

3  Terms and Definitions

3.1
Reproductive toxicity
Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. For classification purposes, the known induction of genetically based inheritable effects in the offspring is addressed in GB 20596-2006. Therefore, in the current classification system, it is more appropriate to discuss such effect according to the hazard types separated based on germ cell mutagenicity.
In this classification system, the reproductive toxicity is subdivided under two main headings: adverse effects on reproductive ability or capacity and adverse effects on development of the offspring.
3.2
Adverse effects on reproductive ability or capacity
Any effect of chemicals that would interfere with reproductive ability or capacity. This may include, but not be limited to, alterations to the female and male reproductive system, adverse effects on onset of puberty, gamete production and transport, reproductive cycle normality, sexual function, fertility, parturition, premature reproductive system senescence, or modifications in other functions that are dependent on the integrity of the reproductive systems.
Adverse effects on or via lactation can also be included in reproductive toxicity, but for classification purposes, such effects are treated separately (see 4.1). This is because it is desirable to be able to classify chemicals specifically for adverse effect on lactation so that a specific hazard warning about this effect can be provided for lactating mothers.