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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
550 µg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
550 µg/L
Assessment factor:
1
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

For hazard assessment the dissociation products of Aluminium trilactate have been regardedin accordance with REACH Regulation (Annex XI, 1.5; read-across based onchemical structure and common physiological activity).

 

Lactate is present in most organisms as a metabolic intermediate andkey substance in several physiological processesand therefore is considered to be nontoxic.

 

Aluminium compounds are natural component comprising 8% of the earth’s crust. Anthropogenic activities contribute only to a minor part to the environmental Aluminium levels. Many publications are related to Aluminium toxicity with regard to mobilisation from the lithosphere due to acidification. Only little is known on the effects of Aluminium under “normal” conditions (LAWA, 2010). The bioavailability and thus toxicity of Al highly depends on environmental conditions like pH and the presence of organic matter.

 

According to WHO (1998) the background concentrations “of aluminium in natural waters can vary significantly depending on various physicochemical and mineralogical factors. Dissolved aluminium concentrations in waters with near-neutral pH values usually range from 0.001 to 0.05 mg/litre but rise to 0.5–1 mg/litre in more acidic waters or water rich in organic matter. At the extreme acidity of waters affected by acid mine drainage, dissolved aluminium concentrations of up to 90 mg/litre have been measured.”

 

PNEC Freshwater and Marine water

Short term toxicity data for three trophic levels (fish, invertebrates, algae) and long term studies for two trophic levels (fish, invertebrates) are available for different Aluminium compounds.

The long term fish study resulted in the lowest NOEC of 13 µg Al/L (or 141.75 µg/L as Aluminium trilactate). This effect concentration is within the range of naturally occurring Aluminium levels in water (from 0.001 to 0.05 mg/L, and up to 0.5 - 1 mg/L in more acidic waters or water rich in organic matter, according to WHO, 1998). LAWA (2010) concluded that even though the studies are inherently valid, such data are not relevant for natural waters. The authors assume that the effective concentrations may be artefacts due to relating to incorrect Aluminium species.

 

Therefore, an alternative approach is used to determine the PNEC is used by LAWA (2010) and Environment Canada (2010).

LAWA (2010) and Environment Canada (2010) suggest a limit concentration (critical toxicity value, CTV) of 50 µg Al/L and 60 µg Al/L, respectively. Following this approach a NOEC of 50 µg Al/L corresponding to 0.55 mg/L Aluminium trilactate will be used, which is also used as PNEC for freshwater as well as for marine water corresponding to an assessment factor of 1.

Considering the current data situation, a differentiation between freshwater and marine water does not seem appropriate (LAWA, 2010).

For classification and labelling both approaches, the one based on the NOEC of 141.75 µg/L as well as the here preferred approach based on the provisional limit concentration of 550 µg/L lead to a classification of Aluminium trilactate as hazardous to the aquatic environment into category Chronic 3.

 

PNEC STP

Inhibition control data from a ready biodegradability test are available. Up to a concentration of 100 mg/L (the highest concentration tested) Aluminium trilactate did not inhibit microbial activity. In accordance with the Technical Guidance Document on Risk Assessment this concentration can beconsidered as a NOEC for the toxicity to microorganisms of an STP. An assessment factor of 10 has been applied as recommended in the TGD.

  

PNEC sediment

No PNEC for sediment has been derived based on Aluminium being a naturally abundant element with highly variable background concentrations. The bioavailability and thus toxicity of Aluminium highly depends on pH. In sediment, the bioavailability of Aluminium is considered to be low.

PNEC Air

Due to the low vapour pressure of Aluminium trilactate release to the atmospheric compartment is unlikely. Therefore, no PNEC for air has been derived.

 

PNEC Soil

No PNEC for soil has been derived based on Aluminium being a naturally abundant element with highly variable background concentrations. “The typical range of aluminum in soils is from 1% to 30% (10,000 to 300,000 mg Al kg-1) (Lindsay, 1979 and Dragun, 1988) with naturally occurring concentrations variable over several orders of magnitude”US EPA (2003).

The bioavailability and thus toxicity of Aluminium highly depends on pH. In soil, the bioavailability of Aluminium is considered to be low.

 

PNEC Secondary poisoning

US ATSDR (2008) concludes that only limited bioconcentration of Aluminium occurs: “The limited information available on bioconcentration in animals appears to indicate that aluminum is not significantly taken up by livestock (DOE 1984). The fact that in studies dealing with aluminum in food, aluminum is generally present in low concentrations in fruit, vegetables, and meat products that do not contain aluminum additives or have other contact with aluminum (e.g., cooked in aluminum pots) (Greger et al. 1985; MAFF 1999; Pennington 1987; Pennington and Schoen 1995; Schenk et al. 1989; Sorenson et al. 1974), would support a conclusion that aluminum does not bioaccumulate in the food chain. Because of its toxicity to many aquatic species, aluminum does not bioconcentrate appreciably in fish and shellfish and therefore, it would not be a significant component of the diet of animals that feed upon them (Rosseland et al. 1990).”

 

 

References

Environment Canada (2010) Environment Canada Priority Substance List Assessment Report, Follow-up to the State of Science Report, 2000 Aluminium Salts (Final Content), available via internet: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=491F0099-1 and http://www.ec.gc.ca/lcpe-cepa/documents/substances/sa-as/final/al_salts-eng.pdf

LAWA (Bund/Länder-Arbeitsgemeinschaft Wasser) (2010)Stoffdatenblatt Aluminium-Kation(14903-36-7), Available via internet: http://www.laenderfinanzierungsprogramm.de/cms/WaBoAb_prod/WaBoAb/Vorhaben/LAWA/Vorhaben_des_Ausschusses_Oberflaechengewaesser_und_Kuestengewaesser_%28AO%29/O_5.07/L4_db_Aluminium_Datenblatt_UQN-Vorschlag_100315.pdf

US ATSDR (United States Agency for Toxic Substances and Disease Registry)(2008) Toxicological profile for Aluminium, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Public Health Service, Agency for Toxic Substances and Disease Registry, available via internet: http://www.atsdr.cdc.gov/toxprofiles/tp.asp?id=191&tid=34

US EPA (United StatesEnvironmental Protection Agency) (2008)Supporting Documents for Initial Risk-Based Prioritization of High Production Volume Chemicals, Sponsored Chemical Lactic Acid (CASRN 50-21-5), available via internet: http://www.epa.gov/chemrtk/hpvis/rbp/Lactic%20Acid_Web_SuppDocs_August%202008.pdf

WHO (World Health Organisation) 1998, Aluminium in Drinking-water, Background document for development of WHOGuidelines for Drinking-water Quality, 2nd ed. Addendum to Vol. 2.Health criteria and other supporting information.

WHO IPCS EHC (World Health Organisation International Programme on Chemical Safety Environmental Health Criteria)(1997) Aluminium (Environmental health criteria; 194), IPCS, World Health Organization, Geneva, available via internet: http://www.inchem.org/documents/ehc/ehc/ehc194.htm  

Conclusion on classification

Based on the available reliable and relevant data, short-term LC50 for fish, aquatic invertebrates, and algae are >1 mg/L. Aluminium trilactate does not need to be classified for acute toxicity to aquatic organisms according to Directive 67/548/EEC or Regulation EC No 1272/2008.

 

Aluminium trilactate is classified as hazardous to the aquatic environment (Category Chronic 3) based on a chronic NOEC for fish of 0.55 mg/L according to Regulation EC No 1272/2008. According to Directive 67/548/EEC no classification for chronic aquatic toxicity is required.