Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

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).

 

Exposure based 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:

 

Exposure Scenario

Substance as such or in a mixture

Contributing scenario with highest RCR

RCR

Manufacturing

As such

Use in contained batch processes with enclosed or vented sampling points

0.07

Formulation

As such

Use in contained batch processes with enclosed or vented sampling points

0.07

Distribution

In a mixture (0.4%)

1.     General exposures (open systems);

2.     Drum and small package filling.

0.07

Industrial fuel use

In a mixture (0.4%)

Equipment maintenance

0.14

Professional fuel use (spark ignition)

In a mixture (0.4%)

Equipment cleaning and maintenance

0.16

Consumer fuel use (spark ignition)

In a mixture (0.4%)

Refuelling gardening equipment

0.00

 

 

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.

Justification for classification or non-classification