6-aminopenicillanic acid

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

no hazard identified

Marine water

Hazard assessment conclusion:

no hazard identified

STP

Hazard assessment conclusion:

no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:

no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:

no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

PNEC

PNEC aqua freshwater = >0.1 mg/L

Assessment Factor = 1000 Extrapolation method: Assessment factor

PNEC aqua marine water = >0.1 mg/L

Assessment Factor = 1000 Extrapolation method: Assessment factor

PNEC aqua (intermittant relaease) = >1 mg/L

Assessment Factor = 100 Extrapolation method: Assessment factor

PNEC STP = > 10 mg/L

Assessment Factor = 100 Extrapolation method: Assessment factor

Aquatic Toxicity:

Short-Term toxicity to fish:

The acute toxicity of the test material to the freshwater fish rainbow trout (oncorhynchus mykiss) was investigates and gave a 96 hour LC50 of greater than 100 mg/L. Correspondingly the No Observed Effect Concentration was 100 mg/L.

In accordance column 2 of REACH Annex IX, the long-term testing on fish study (required in section 9.1.6) is only required if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. The chemical safety assessment of 6-Aminopenicillanic acid indicates no cause for concern for aquatic organisms. Hence, long-term toxicity test on fish are not required.

Short-Term toxicity to aquatic invertebrates:

The acute toxicity of the test material to the freshwater invertebrate Daphnia magna has been investigated and gave a 48-Hour EC50 of greater than 100 mg/L. Correspondingly the No Observed Effect Concentration was 100 mg/L.

In accordance column 2 of REACH Annex IX, the long-term testing on aquatic invertebrates is only required if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. The chemical safety assessment of 6-Aminopenicillanic acid indicates no cause for concern for aquatic organisms. Hence, long-term toxicity test on aquatic invertebrates are not required.

Toxicity to aquatic algae and cyanobacteria:

The effect of the test material on the growth of Desmodesmus subspicatus has been investigated over a 72-Hour period and gave the following results:

Growth Rate EC50 (mg/L): 55 (95% Confidence Limits (mg/L) 54-57

Growth Rate No Observed Effect Concentration (NOEC) (mg/L) 25

Growth Rate Lowest Observed Effect Concentration (LOEC) (mg/L): 50

Yield EC50 (mg/L): 45 (95% Confidence Limits (mg/L) 39-53)

Yield No Observed Effect Concentration (NOEC) (mg/L) 25

Yield Lowest Observed Effect Concentration (LOEC) (mg/L): 50

The effect of the test material on the growth of Desmodesmus subspicatus based on the geometric mean measured test concentrations gave the following results:

Growth Rate EC50 (mg/L): 43 95% Confidence Limits (mg/L) 42-45

Growth Rate No Observed Effect Concentration (NOEC) (mg/L) 14

Growth Rate Lowest Observed Effect Concentration (LOEC) (mg/L): 38

Yield EC50 (mg/L): 32 (95% Confidence Limits (mg/L) 27-39)

Yield No Observed Effect Concentration (NOEC) (mg/L) 14

Yield Lowest Observed Effect Concentration (LOEC) (mg/L): 38

The effect of 6-Aminopenicillanic acid on the growth of Desmodemus subspiculus is attributed to the physicochemical property of the substance and not its toxic property. Therefore the above results are not considered relevant for classification.

Toxicity to aquatic plants other than algae:

Although the results from section 9.2.1.1 demonstrated the test material was found not to be readily biodegradable, the nature of the test material demonstrated the potential for rapid degradation.Any waste is treated in a treatment plant on site, therefore levels released to the environment would be minimal.Beta-lactams naturally occur in the environment as they are produced by penicillium fungi (moulds) which are present in typically cool, damp environments rich in organic matter.

Toxicity to microoganisms:

The effect of the test material on the respiration of activated sewage sludge micro-organisms gave a 3-Hour EC50 of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 590 mg/L.

Sediment Toxicity:

In accordance with section 1 of REACH Annex XI (testing does not appear scientifically necessary), the long-term toxicity to sediment organisms (required in section 9.5.1.) does not need to be conducted as the hazard assessment performed during the chemical safety assessment concludes that there no immediate concern to the environment. Although the results from section 9.2.1.1 demonstrated the test material was found not to be readily biodegradable, the nature of the test material demonstrated the potential for rapid degradation. Exposure to soil is also considered unlikely as the substance is an intermediate and undergoes further manufacturing processes before the end product is released. Any waste is treated in a treatment plant on site; therefore levels released to the environment would be minimal. Beta-lactams naturally occur in the environment as they are produced by penicillium fungi (moulds) which are present in typically cool, damp environments rich in organic matter.

Terrestrial Toxicity:

Short and Long term terrestrial toxicity studies is not justified for 6-Aminopenicillanic Acid for the following reasons:

-hazard assessment performed during the chemical safety assessment concludes that the substance is of no immediate concern to the environment.

-Although the results from section 9.2.1.1 demonstrated the test material was found not to be readily biodegradable, the nature of the test material demonstrated the potential for rapid degradation.

- Exposure to soil is also considered unlikely as the substance is an intermediate and undergoes further manufacturing processes before the end product is released. Any waste is treated in a treatment plant on site; therefore levels released to the environment would be minimal.

-Beta-lactams naturally occur in the environment as they are produced by penicillium fungi (moulds) which are present in typically cool, damp environments.