Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Study data for Alchisor CAL 123, where available, have been evaluated and considered for assessment. Reliable data were available for short-term toxicity to invertebrates, short-term toxicity to fish, toxicity to algae and toxicity to microorganisms. In a conservative approach the most sensitive study result related to each endpoint was chosen as Key and is summarized below.There were no reliable long-term toxicity data for fish, invertebrates or aquatic plants therefore a waiver is being applied for these endpoints.

 

Short-term Toxicity to Fish

The short-term toxicity of Alchisor CAL 123, characterized as Alkenes, C11-12, hydroformylation products, distillation residues, to fish has been evaluated for this dossier. One reliable (Klimisch 1) short-term toxicity study for fish was available for Alchisor CAL 123. The short-term toxicity of Alchisor CAL 123 to the fathead minnow (Pimephales promelas) was reported by Claude & Krueger (2010) in an OECD 203 guideline and GLP compliant study. Fish were exposed to the test substance in measured concentrations for 96 hours, resulting in a 96-hr LC50 of >100 mg/L. This reliable study result is designated as Key for the short-term toxicity to fish endpoint.

 

Long-term Toxicity to Fish

Alchisor CAL 123 comprises Alkenes C11-12, hydroformylation products, distillation residues and where environmental toxicity data exist, these are representative of the Alchisor CAL 123 substance. In accordance with REACH Annex IX, the requirement for long-term toxicity to fish is waived on the basis that the substance is readily biodegradable and has low toxicity to aquatic life. No reliable predicted or measured long-term toxicity to fish data are available for Alchisor CAL 123.

 

 

Short-term Toxicity to Invertebrates

The short-term toxicity of Alchisor CAL 123, characterized as Alkenes, C11-12, hydroformylation products, distillation residues, to invertebrates has been evaluated for this dossier. One reliable (Klimisch 1) short-term toxicity study for invertebrates was available for Alchisor CAL 123. The short-term toxicity of Alchisor CAL 123 to Daphnia magna was reported by Claude & Krueger (2010) in an OECD 202 guideline and GLP compliant study. Daphnia were exposed to the test substance in measured concentrations for 48 hours, resulting in a 48-hr LC50 of >100 mg/L. This reliable study result is designated as Key for the short-term toxicity to invertebrates endpoint.

 

Long-term Toxicity to Invertebrates

Alchisor CAL 123 comprises Alkenes C11-12, hydroformylation products, distillation residues and where environmental toxicity data exist, these are representative of the Alchisor CAL 123 substance. In accordance with REACH Annex IX, the requirement for long-term toxicity to invertebrates is waived on the basis that the substance is readily biodegradable and has low toxicity to aquatic life. No reliable predicted or measured long-term toxicity to invertebrates data are available for Alchisor CAL 123.

 

Toxicity to Aquatic Algae

The toxicity of Alchisor CAL 123, characterized as Alkenes, C11-12, hydroformylation products, distillation residues, to aquatic algae and bacteria has been evaluated for this dossier. One reliable (Klimisch 1) toxicity study for aquatic algae was available for Alchisor CAL 123. The toxicity of Alchisor CAL 123 to Pseudokirchnerella subcapitata was reported by Porch & Krueger (2010) in an OECD 201 guideline and GLP compliant study. Algae was exposed to the test substance in measured concentrations for 72 hours, resulting in a 72-hr LC50 of 35 mg/L, based on cell density and yield. The 72-hr NOEC, based on growth rate, was 25 mg/L. This reliable study result is designated as Key for the toxicity to aquatic algae endpoint.

 

Toxicity to Microorganisms

The toxicity of Alchisor CAL 123, characterized as Alkenes, C11-12, hydroformylation products, distillation residues, to microorganisms has been evaluated for this dossier. One reliable (Klimisch 1) toxicity study for microorganisms was available for Alchisor CAL 123. The toxicity of Alchisor CAL 123 to activated sludge was reported by Schaefer & Twilly (2010) in an OECD 209 guideline and GLP compliant study. Activated sludge was exposed to nominal concentrations of the test substance for 3 hours, resulting in a 3-hr LC50 of >1,000 mg/L, based on respiration. This reliable study result is designated as Key for the toxicity to microorganisms endpoint.

 

Study data for Alchisor CAL 123, where available, has been evaluated and considered for assessment. Reliable data was available for short-term toxicity to invertebrates, short-term toxicity to fish, toxicity to algae, and toxicity to microorganisms. No reliable long-term data for fish or invertebrates were available. Data requirements for long-term toxicity data for fish, invertebrates and aquatic plants are waived.