Data requirements

Last update 30 November 2016

Data requirements for notification of new chemicals

Variation to data requirements

If you consider a specified test or data item to be irrelevant, unnecessary or scientifically inappropriate in evaluating the potential occupational health, public health and environmental hazards of the chemical you can omit it, as long as you justify the omission under the appropriate item heading.

Examples may include, provision of a data item being scientifically inappropriate, not technically possible or not economically feasible. NICNAS can allow the variation or recommend that you substitute certain alternative data items.

Examples of variations to data requirements:

  • If the chemical is a gas at room temperature, a feeding study cannot be carried out.
  • An eye irritation test may be unnecessary for chemicals with a pH above 11.5 or below 2 as irritant effects are assumed.
  • If data show that the chemical is a skin sensitiser in humans, then a skin sensitisation test in animals is not required.
  • Acute inhalation toxicity results are not required if the chemical:
    • has a vapour pressure <1.5 kPa
    • as introduced has <25% of particles having <10 μm diameter
    • is not purposely atomised during use (except where this constitutes a 'controlled' use).

You must fully justify omissions in data based on economic grounds if you consider or believe that:

  • generating a particular data item required by the schedule is not economically feasible
  • the data item is not essential for adequate occupational health and safety, public health and environmental assessment of the chemical
  • the cost of generating the data may prohibit the introduction of the chemical
  • the omission will not affect the preparation of an adequate assessment.

NICNAS will not consider claims for omitting data based solely on the administrative costs associated with preparing a submission.