# 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: TEST REPORT

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

The test report must include the following information:
Test substance:
physical nature and, where relevant, physicochemical properties;
identification data;
purity.
Vehicle (if appropriate):
justification for choice of vehicle if other than water.
Test animals:
species/strain used;
number, age and sex of animals;
source, housing conditions, diet, nesting materials, etc.;
individual weights of animals at the start of the test.
Test conditions:
rationale for dose level selection;
details of test substance formulation/diet preparation, achieved concentrations;
stability and homogeneity of the preparation;
details of the administration of the test substance;
conversion from diet/drinking water test substance concentration (ppm) to the achieved dose (mg/kg body weight/day), if applicable;
details of food and water quality.
Results:
food consumption, and water consumption if available, food efficiency (body weight gain per gram of food consumed), and test material consumption for P and F1 animals, except for the period of cohabitation and for at least the last third of lactation;
absorption data (if available);
body weight data for P and F1 animals selected for mating;
litter and pup weight data;
body weight at sacrifice and absolute and relative organ weight data for the parental animals;
nature, severity and duration of clinical observations (whether reversible or not);
time of death during the study or whether animals survived to termination;
toxic response data by sex and dose, including indices of mating, fertility, gestation, birth, viability, and lactation; the report should indicate the numbers used in calculating these indices;
toxic or other effects on reproduction, offspring, post-natal growth, etc.;
necropsy findings;
detailed description of all histopathological findings;
number of P and F1 females cycling normally and cycle length;
total cauda epididymal sperm number, percent progressively motile sperm, percent morphologically normal sperm, and percent of sperm with each identified abnormality;
time-to-mating, including the number of days until mating;
gestation length;
number of implantations, corpora lutea, litter size;
number of live births and post-implantation loss;
number of pups with grossly visible abnormalities, if determined the number of runts should be reported;
data on physical landmarks in pups and other post natal developmental data; physical landmarks evaluated should be justified;
data on functional observations in pups and adults, as applicable;
tatistical treatment of results, where appropriate.
Discussion of results.
Conclusions, including NOAEL values for maternal and offspring effects.

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Source: https://www.legislation.gov.uk/eudr/2004/73/annex/n8/division/B.35/division/3/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-73/annex-n8/division-B.35/division-3/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.