Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Hazard for predators

Additional information

There are no studies on the ecotoxicity of isoheptane available. Based on a category approach data are either read-across to hydrocarbons, C7-C9, isoalkanes or the analogue substance 2,3,4-trimethylpentane, or are estimated using the Petrotox computer model (v. 3.04). The most conservative results of aquatic studies are: EL50 of 2.4 mg/L (Daphnia, measured), LL50 of 18.4 mg/L (fish, measured), and EL50 of 8.2 mg/L (algae, estimated). Studies were conducted in Water Accomodated Fraction (WAF) studies because of the limited water solubility. QSAR modelling data on microorganisms resulted in an EL50 of 42.75 mg/L. One study in the category is available on chronic aquatic toxicity for Daphnia with a NOELR of 1 mg/L. QSAR modelling was performed to further address chronic toxicity of isoheptane and NOELRs were in the range of 2.42 to 1.83 mg/L for fish and algae. 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. The assessment indicated no risk to the environment. 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 inherently biodegradable. The most sensitive acute aquatic value is an EL50 of 2.4 mg/L (Daphnia, freshwater). A BCF is estimated to be 129 and the log Kow is estimated to be 3.7. Measured and estimated chronic values for all three trophic levels are in the range of 1 - 8.2 mg/L.

The substance is classified R50/53 according to DSD/DPD based on listing on Annex I and classified aquatic acute category 1 and aquatic chronic category 1 according to harmonised classification acc. to Annex VI (CLP).