# Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance), Division 1.2: DEFINITIONS

Extent: E+W+S+N.I.

Developmental toxicology: the study of adverse effects on the developing organism that may result from exposure prior to conception, during prenatal development, or postnatally to the time of sexual maturation. The major manifestations of developmental toxicity include 1) death of the organism, 2) structural abnormality, 3) altered growth, and 4) functional deficiency. Developmental toxicology was formerly often referred to as teratology.
Adverse effect: any treatment-related alteration from baseline that diminishes an organism's ability to survive, reproduce or adapt to the environment. Concerning developmental toxicology, taken in its widest sense it includes any effect which interferes with normal development of the conceptus, both before and after birth.
Altered growth: an alteration in offspring organ or body weight or size.
Alterations (anomalies): structural alterations in development that include both malformations and variations (28).
Malformation/Major Abnormality: Structural change considered detrimental to the animal (may also be lethal) and is usually rare.
Variation/Minor Abnormality: Structural change considered to have little or no detrimental effect on the animal; may be transient and may occur relatively frequently in the control population.
Conceptus: the sum of derivatives of a fertilised ovum at any stage of development from fertilisation until birth including the extra-embryonic membranes as well as the embryo or foetus.
Implantation (nidation): attachment of the blastocyst to the epithelial lining of the uterus, including its penetration through the uterine epithelium, and its embedding in the endometrium.
Embryo: the early or developing stage of any organism, especially the developing product of fertilisation of an egg after the long axis appears and until all major structures are present.
Embryotoxicity: detrimental to the normal structure, development, growth, and/or viability of an embryo.
Foetus: the unborn offspring in the post-embryonic period.
Foetotoxicity: detrimental to the normal structure, development, growth, and/or viability of a foetus.
Abortion: the premature expulsion from the uterus of the products of conception: of the embryo or of a nonviable foetus.
Resorption: a conceptus which, having implanted in the uterus, subsequently died and is being, or has been resorbed.
Early resorption: evidence of implantation without recognisable embryo/foetus
Late resorption: dead embryo or foetus with external degenerative changes
NOAEL: abbreviation for no-observed-adverse-effect level and is the highest dose or exposure level where no adverse treatment-related findings are observed.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n7/division/B.31/division/1/division/1.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n7/division-B.31/division-1/division-1.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.