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Division 4 REFERENCES

United Kingdom

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Table 1:

Minimum numbers of animals needed per group when the neurotoxicity study is conducted separately or in combination whit studies

Includes five animals selected for functional testing and detailed clinical observations as part of the neurotoxicity study
NEUROTOXICITY STUDY CONDUCTED AS:
Separate studyCombined study with the 28-day studyCombined study with the 90-day studyCombined study with the chronic toxicity study
Total number of animals per group10males and 10 females10males and 10 females15males and 15 females25males and 25 females
Number of animals selected for functional testing including detailed clinical observations10males and 10 females10males and 10 females10males and 10 females10males and 10 females
Number of animals selected per perfusion in situ and neurohistopathology5males and 5 females5males and 5 females5males and 5 females5males and 5 females
Number of animals selected for repeated dose/subchronic/chronic toxicity observations, haematology, clinical biochemistry, histopathology, etc. as indicate in the respective Guidelines5males and 5 females10malesf1 and 10 females 20malesand 20 females
Supplemental observations, as appropriate5males and 5 females

Table 2:

Frequency of clinical observation and functional tests

Type of observations Study duration
Acute 28-day 90-day Chronic
In all animals General health condition dailydailydailydaily
Mortality/morbidity Twice dailyTwice dailyTwice dailyTwice daily
In animals selected for functional observations Detailed clinical observations

  • prior to first exposure

  • within 8 hours of dosing at estimate time of peak effect

  • at day 7 and 14 after dosing

  • prior to first exposure

  • once weekly thereafter

  • prior to first exposure

  • once during the first or second week of exposure

  • monthly thereafter

  • prior to first exposure

  • once at the end of the first month of exposure

  • every three months thereafter

Functional tests

  • prior to first exposure

  • within 8 hours of dosing at estimate time of peak effect

  • at day 7 and 14 after dosing

  • prior to first exposure

  • during the fourth week of treatment as close as possible to the end of the exposure period

  • prior to first exposure

  • once during the first or second week of exposure

  • monthly thereafter

  • prior to first exposure

  • once at the end of the first month of exposure

  • every three months thereafter
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Annotations

Footnotes

f1

Includes five animals selected for functional testing and detailed clinical observations as part of the neurotoxicity study