A.I.S.E. use information to support preparation of registration dossiers and communication in the supply chain
A.I.S.E. REACT: Reach Exposure Assessment Consumer Tool
The A.I.S.E. REACT Consumer Tool allows quantitative
estimation of systemic consumer exposures to substances that are
present in preparations used by consumers. The tool calculates
substance exposure via inhalation, dermal, and oral routes separately
and also provides a summation of all the relevant exposure routes. The
tool can also calculate Risk Characterization Ratios (RCR) for the
different exposure routes separately and for the overall exposure. RCRs
are only calculated provided that substance specific hazard data values
(e.g., DNELs) are entered in the User Input worksheet by the user. The
tool does not provide hazard data values and these need to be defined
by the user.
This User Manual provides guidance for working with the A.I.S.E. REACT Consumer Tool.
Tiered approach for exposure assessment, including table of “Habits and Practices” for consumers
Table 4: Product categories for which quantification of exposure is
addressed by HERA methodology, to be considered as guidance for
Note: Accidental exposure is indicated only for product stewardship reasons, not for Exposure Scenarios development.
Table 5: Habits and practices for a range of detergents and cleaning products used in the consumer sector (human health part)
As the ECHA guidances on information requirement and chemical
safety assessment indicates a “tiered” or staged approach to exposure assessment is recommended.
A.I.S.E. believes that both simplicity and flexibility
are essential for exposure assessment. Applying a tiered approach is
the only way to keep the workload manageable.
In general, such a tiered approach would entail:
- Using the ECETOC Targeted Risk Assessment tool
and scenarios as a first step, where applicable. Other tools may also
- Refine the exposure assessment by using higher-tier tools when necessary.
The diagram below graphically represents exposure assessment tools that apply at each “Tier”/level:
- Tier 1:
'Easy' cases are dealt with by Tier-1 assessments. A.I.S.E. supports
the substance suppliers in their exposure assessments by providing them
with information on uses as outlined in the following link: Use description and mapping for cleaning and maintenance products. This basic use information (use descriptors) serves to direct the assessment using the ECETOC TRA exposure estimation tool.
- Tier 1.5:
For refining the Tier-1 exposure estimations, A.I.S.E. has collected
additional information. It includes refined exposure parameters such as
duration and frequency of exposure (workers, consumers, and
environment), refined emission fractions (environment), and possible
risk management measures (workers, consumers, and environment). The
information has been collected among other as part of the HERA project (http://www.heraproject.com).
This additional information can be processed in the ECETOC TRA exposure
assessment tool. A.I.S.E. refers to the resulting assessments as Tier
- Higher-Tier: the additional information also serves
as input for Tier 2 exposure estimations. The above diagram shows an
arbitrary selection of higher Tier exposure assessment tools which may
be found appropriate and are frequently applied in our sector.
finally, the assessor may come to the conclusion, that exposure
estimation is insufficient to demonstrate that the use is safe. In that
case, exposure measurements represent an additional option.
For more information on uses and exposure see section:
Use description and mapping for cleaning and maintenance products
- Higher-tier assessments:
More detailed information on “operational conditions” for a range of
detergent products used by consumers is made available in the Table of
Habits and Practice below.
This information was originally developed under the voluntary risk
assessment HERA project http://www.heraproject.com). Such detailed information would primarily be used when “higher-tier” tools need to be considered.
Table 4 below illustrates the exposure routes, by
product category (for consumer uses only), that may require in-depth
assessment for human health.
Table 5 shows the detailed operational conditions (habits and practices) for the range of A.I.S.E. consumer products.