Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.066 mg/L
Assessment factor:
1
Extrapolation method:
sensitivity distribution
PNEC freshwater (intermittent releases):
0.066 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.066 mg/L
Assessment factor:
1
Extrapolation method:
sensitivity distribution

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.01 mg/L
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
9.108 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
9.108 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.565 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Before the current ECHA nomenclature rules became effective, we adopted the IUPAC name Hydrocarbons, C7-9, n-alkanes, isoalkanes, cyclics (EC number 920-750-0) as the identifier for the substance and this was the name that was used during the pre-registration phase of REACH. Also during this time, samples of the product were collected and the required physicochemical studies were conducted. The resulting robust studies summaries were entered into the IUCLID dossier using this name and EC number.

Between 2008 and 2009 ECHA issued a specific document about the nomenclature to be used under REACH, the so called REACH Implementation Project 3.10. The implications of this document to the appropriate nomenclature for the registered substance were only fully understood by us beginning in late 2009/early 2010.

As such, during the creation of the robust study summaries in IUCLID, the discrepancy with the substance naming was not noticed. As a result, it appears in IUCLID that the tested substance indicated is not the same as the registered one; however, if robust study summaries and/or associated study reports use the substance name “Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics,” they are actually referring to the registered substance “Hydrocarbons, C7-C8, n-alkanes” according to the revised REACH nomenclature rules.

The ecotoxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics has been examined in a series of studies on fish, Daphnia and algae, and additional QSAR modelling has been performed. The most conservative results of aquatic studies showed this substance to be of moderate toxicity, with LL50 or EL50 values of 3 mg/L (fish), 4.6 mg/L (Daphnia), and 10 mg/L (algae). All studies were conducted using Water Accommodated Fractions (WAFs) studies because of the limited water solubility. QSAR modelling data on microorganisms resulted in an EL50 of 11.14 mg/L. A study on the chronic toxicity to Daphnia resulted in a NOELR of 1 mg/L. Further QSAR modelling was performed to address chronic toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to fish and a NOELR was found to be 0.574 mg/L. Standard tests for terrestrial endpoints are intended for single substances and are not appropriate for the risk assessment of this complex substance. For the purpose of risk assessment, soil PNECs for hydrocarbon blocks have been derived using aquatic PNECs and the equilibrium partitioning method (EqP) using representative structures. Studies on long-term or reproductive toxicity to birds do not need to be conducted due to the existence of a large mammalian dataset demonstrating low toxicity to higher organisms.

Conclusion on classification

The substance is readily biodegradable (read-across). The most sensitive acute aquatic values is an LL50 of 3 mg/L (fish). The chronic toxicity value is 1 mg/L (experimental result) or 0.574 mg/L (estimated with PETRORISK model). Thus, the substance is not classified according to EU GHS, but classified R 51/53 according to DSD/DPD.