Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data available: testing technically not feasible

Marine water

Hazard assessment conclusion:
no data available: testing technically not feasible

STP

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (freshwater)

Hazard assessment conclusion:
no data available: testing technically not feasible

Sediment (marine water)

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no data available: testing technically not feasible

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

There is no data available for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics. Data is read across from structural analogues such as Hydrocarbons, C9-C14 aliphatics, 2-25% aromatics and Hydrocarbons, C14-C20 aliphatic, 2-30% aromatics. Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.

 

The environmental effects of the hydrocarbons, C9-C12, aliphatics, 2-25% aromatics has been defined by a series of studies on fish, Daphnia, and algae. Results of the key studies showed that this substance would exhibit LL50 or EL50 values (based on loading rate of water accommodated fractions) of 10-30 mg/L (fish), 10-22 mg/L (Daphnia), and 4.1 and 4.6 -10 mg/L (for both growth and biomass of algae). All of these studies were conducted using Water Accommodated Fraction (WAF) methodology because of the complex composition and limited water solubility of constituents in hydrocarbons, C9-C12, aliphatics, 2 -25% aromatics.

 

Chronic toxicity to fish was estimated to be 0.13 mg/L (NOELR based on growth). Studies on invertebrates and algae found NOELR of 0.28 mg/L (based on reproduction) and 0.16 / 0.22 mg/L (based on algal biomass) respectively.

 

The environmental effects of the hydrocarbons, C10-C13, aliphatics, 2 -25% aromatics has been defined by a series of studies on fish, Daphnia, and algae. Results of the key studies showed that this substance would exhibit LL50 or EL50 values (based on loading rate of water accommodated fractions) of 10-100 mg/L (fish), 100-220 mg/L (Daphnia), and 10 -100 mg/L (for both growth and biomass of algae). All of these studies were conducted using Water Accommodated Fraction (WAF) methodology because of the complex composition and limited water solubility of constituents in hydrocarbons, C10 -13, aliphatics, 2 -25% aromatics.

 

Chronic toxicity to fish was estimated to be 0.091 mg/L (NOELR based on growth). Studies on algae found a 72 -hour NOEL of 3 mg/L (based on growth and biomass).

 

The environmental effects of the hydrocarbons, C11-C14, aliphatics, 2 -25% aromatics has been defined by a study on fish. Chronic toxicity to fish was estimated to be 0.079 mg/L (NOELR based on growth).

 

The estimated protozoan,Tetrahymena pyriformis 48-hr EL50 value for Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 43.98 mg/L, based on growth inhibition.

 

The estimated protozoan,Tetrahymena pyriformis 48-hr EL50 value for Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is 185.1 mg/L, based on growth inhibition.

 

The substances belonging to the category "Hydrocarbons, C9 -C14, aliphatics (2-25% aromatics)" have shown to be biodegradable. Therefore, they are not toxic to microorganisms.

 

The environmental effects of Hydrocarbons, C14-20 Aliphatics (2-30% aromatic) has been defined by a series of studies on fish, Daphnia, and algae.

Water accommodated fractions of hydrocarbons, C16 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause acute toxicity to fish at a nominal loading of 1000 mg/L with rainbow trout, Oncorhynchus mykiss.

 

Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause toxicity to fish in a 21-day toxicity study with Brachydanio rerio following standard test guidelines at a nominal loading of 5000 mg/L. These results indicate that hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) is not expected to be chronically toxic to fish.

 

Water accommodated fractions of hydrocarbons, C16 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause acute toxicity to the freshwater invertebrate, Daphnia magna at a nominal loading of 1000 mg/L.

 

Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause toxicity in a 21-day toxicity study with Daphnia magna following standard test guidelines at a nominal loading of 1400 mg/L, with a NOELR of 17 mg/L (based on inhibition of reproduction). These results indicate that hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) is not expected to be chronically toxic to freshwater invertebrates.

 

The estimated freshwater invertebrate 21-day NOELR (No Observed Effect Loading Rate) value for Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) determined using the Petrotox computer model (CONCAWE, 2010) is 0.162 mg/L in Daphnia magna, based on reproduction.

 

Water accommodated fractions of hydrocarbons, C16 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) did not cause acute toxicity to the freshwater green algae, Pseudokirchneriella subcapitata, at a nominal loading of 1000 mg/L.

 

Water Accommodated Fractions of hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%), did not inhibit microbial respiration in a sludge sample at a concentration of 1000 mg/L. Therefore, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%), is not expected to adversely affect microbial activity in a wastewater treatment plant.

 

These data are used as read across data for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics.

Conclusion on classification

There is no data available for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics. Data is read across from structural analogues such as Hydrocarbons, C9-C14 aliphatics, 2-25% aromatics and Hydrocarbons, C14-C20 aliphatic, 2-30% aromatics.Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.

 

These data are used as read across data for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics.

For purposes of environmental classification, hydrocarbons, C9-C12, aliphatics, 2 -25% aromatics fall within a 1 to 10 mg/L range for acute aquatic toxicity. These substances are considered to be readily biodegradable.

 

For purposes of environmental classification, hydrocarbons, C10-C13, aliphatics, 2 -25% aromatics fall within a 10 to 100 mg/L range for acute aquatic toxicity. These substances are considered to be readily biodegradable.

For purposes of environmental classification, hydrocarbons, C11 -C14, aliphatics, 2 -25% aromatics fall within a 10 to 100 mg/L range for acute aquatic toxicity. These substances are considered to be readily biodegradable.

Hydrocarbons, C16 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) is classified for the environment based on available acute and chronic toxicity test data. Although not acutely toxic, this substance is considered inherently biodegradable, demonstrating an aerobic biodegradation potential of 59.1% in 28 days and chronic toxicity test results indicate a potential to cause chronic effects, resulting in a classification of R53.

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