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EC number: 701-241-0
CAS number: -
REACH provides for the
option that information requirements may be adapted based on the
justification that exposure is absent or not significant (Annex XI,
section 3.2(a) (i); Annex VIII column 2 section 8.6.1 and 8.7.1) or
unlikely (Annex IX column 2 section 9.4).
adaptation (EBA) is based on the general rules for adaptation of the
standard testing regime laid down in Annex XI section 3: Here it is
stated that ‘testing may be omitted based on the exposure scenarios
developed in the chemical safety report. The justification shall be
based on a thorough and rigorous exposure assessment in accordance with
section 5 of Annex I (see Guidance on information requirements and
chemical safety assessment Chapter R.5: Adaptation of information
requirements. August, 2010).
The interpretation in
this guidance document is that exposure-based adaptation of information
requirements under REACH should take into account available knowledge on
i) substance physicochemical properties, ii) hazard information covering
a certain endpoint, iii) the conditions of use and iv) the expected
releases and/exposure under these conditions.
If EBA is based on
Annex XI section 3, a qualitative or quantitative risk characterisation
is required, based on a rigorous exposure assessment according to Annex
1. The qualitative risk characterisation establishes control of risk by
demonstrating that i)strictly controlled conditions apply or ii) that no
releases are to be expected, and thus the likelihood of exposure is
negligible. A quantitative risk characterisation establishes control of
risk by demonstrating that the risk characterisation ratio is well below
1, taking full account of the increased uncertainty resulting from the
omission of the information requirement, and that DNEL or PNEC is
relevant and appropriate both to the information requirement to be
omitted and for risk assessment purposes.
Reaction Products of C3
alcohols and C3 alkenes obtained as by-products from the
manufacture of propan-2-ol by hydration of propylene
is a UVCB substance. Reliable DNELs or PNECs have been derived based on
the hazard information of its constituents. A rigorous exposure
assessment according to Annex 1, and subsequently a quantitative risk
characterization using the science-based DNELs have been performed. The
RCRs for all exposure routes combined have been calculated, and the
highest RCR per exposure scenario are as follows:
Substance as such or in a mixture
Contributing scenario with highest RCR
Use in contained batch processes with enclosed or vented sampling points
In a mixture (0.4%)
1. General exposures (open systems);
2. Drum and small package filling.
Industrial fuel use
Professional fuel use (spark ignition)
Equipment cleaning and maintenance
Consumer fuel use (spark ignition)
Refuelling gardening equipment
The highest RCR for all
exposure routes combined is 0.16 (Professional fuel use, Equipment
cleaning and maintenance). This value is considered to be well below 1.
Hence negligible risk can be demonstrated and further testing is waived.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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