Alcohols, C6-24 and C6-24-unsatd., distn. residues

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

Exposure based adaptation of information requirements:

According to REGULATION (EC) No 1907/2006, Annex IX and Annex X, reproductive toxicity testing (section 8.6) may be omitted, if relevant human exposure can be excluded in accordance with Annex XI section 3. Furthermore and in accordance with section 3.2 (b) of Annex XI (as amended by Regulation 134/2009), testing for reproductive toxicity can be omitted when the substance is not incorporated in an article and the manufacturer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4)(a) to (f) (Regulation 1907/2006) apply.

 

Life-cycle stage(s) covered:

1.Production of distillation residues (PROCs 1, 8b)

2.Use of distillation residues in production of energy products (PROC 1, 3, 8b)

3.Use of distillation residues as renewable energy source (PROC 1, 8b, 16)

 

Classification:

H341: Suspected of causing genetic defects.

The substance is not harmful after single ingestion and single dermal application. Additionally, the substance is not considered to be corrosive to skin as well as the eyes. The substance is not a skin sensitizer. No effects occurred in the bacterial reverse mutation assay and the HPRT assay. Based on effects in the micronucleus test the test substance is considered to be mutagenic in the absence of a metabolic activation system.

 

Process description:

Saturated and/or unsaturated fatty acids or triglycerides are transferred to methyl esters by esterification/transesterification processes with Methanol. Methylesters are transferred to saturated and unsaturated fatty Alcohols by partial catalytic reduction with hydrogen. The Fatty alcohols are purified by vacuum distillation, delivering fatty alcohols in the distillate and the distillation residues, which are topic of this registration in the distillation sump.

After the destillation is completed, the distillation residue is transferred via a closed dedicated pipeline to a buffer tank, where the residue is stored at 40-50°C. Sampling is not required for this process step. The reactor can immediately be used for the next destillation.

The process is operated discontinuously at elevated temperature. The reactor is located outdoors. Due to the closed system, exposure to workers will not take place under normal operation conditions.

Thereafter, the distillation residue is transported from the storage tank to the filling station under strictly controlled conditions. Here, the residue is filled in a transport vehicle under strictly controlled conditions. Exposure to workers will not take place under normal operation conditions. Then, the residue is transported to the powerplant via street where it is blended with other residues or directly pumped into the powerplant under strictly controlled conditions.

The substance is used as fuel in powerplants in closed systems similar to mineral oil products.The use is dedicated to large powerplants industrial style with the confirmation of strictly controlled conditions similar to the use of on site resprective transported intermediates. Any widespread use by professional workers or consumers (e. g. in neighbourhood small block heat and powerplants) is a use advised against.

 

 

 

Rigorous containment measures:

The substance is manufactured and used under strictly controlled conditions over the entire lifecycle. Transport, storage tanks, reactors and processing equipment operate in fully closed systems.

Procedural and control technologies are used to minimise residual emissions/exposure as well as qualitative risk considerations:

Operational and technical conditions and measures affecting and controlling workers exposure, as well as personal protective equipment, such as goggles, chemically resistant gloves, and respiratory protection where potential exposure may occur as reported in the CSR are followed (see chapters 9 & 10).

On the basis of the described process conditions, testing of the distillation residue in an extended one generation study was not performed since the criteria of exposure based adaptation of information requirements are met.

Effects on developmental toxicity

Additional information

Exposure based adaptation of information requirements:

According to REGULATION (EC) No 1907/2006, Annex IX and Annex X, teratogenicity testing may be omitted, if relevant human exposure can be excluded in accordance with Annex XI section 3. Furthermore and in accordance with section 3.2 (b) of Annex XI (as amended by Regulation 134/2009), testing for teratogenicity can be omitted when the substance is not incorporated in an article and the manufacturer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4)(a) to (f) (Regulation 1907/2006) apply.

 

Life-cycle stage(s) covered:

1.Production of distillation residues (PROCs 1, 8b)

2.Use of distillation residues in production of energy products (PROC 1, 3, 8b)

3.Use of distillation residues as renewable energy source (PROC 1, 8b, 16)

 

Classification:

H341: Suspected of causing genetic defects.

The substance is not harmful after single ingestion and single dermal application. Additionally, the substance is not considered to be corrosive to skin as well as the eyes. The substance is not a skin sensitizer. No effects occurred in the bacterial reverse mutation assay and the HPRT assay. Based on effects in the micronucleus test the test substance is considered to be mutagenic in the absence of a metabolic activation system.

 

Process description:

Saturated and/or unsaturated fatty acids or triglycerides are transferred to methyl esters by esterification/transesterification processes with Methanol. Methylesters are transferred to saturated and unsaturated fatty Alcohols by partial catalytic reduction with hydrogen. The Fatty alcohols are purified by vacuum distillation, delivering fatty alcohols in the distillate and the distillation residues, which are topic of this registration in the distillation sump.

After the destillation is completed, the distillation residue is transferred via a closed dedicated pipeline to a buffer tank, where the residue is stored at 40-50°C. Sampling is not required for this process step. The reactor can immediately be used for the next destillation.

The process is operated discontinuously at elevated temperature. The reactor is located outdoors. Due to the closed system, exposure to workers will not take place under normal operation conditions.

Thereafter, the distillation residue is transported from the storage tank to the filling station under strictly controlled conditions. Here, the residue is filled in a transport vehicle under strictly controlled conditions. Exposure to workers will not take place under normal operation conditions. Then, the residue is transported to the powerplant via street where it is blended with other residues or directly pumped into the powerplant under strictly controlled conditions.

The substance is used as fuel in powerplants in closed systems similar to mineral oil products.The use is dedicated to large powerplants industrial style with the confirmation of strictly controlled conditions similar to the use of on site resprective transported intermediates. Any widespread use by professional workers or consumers (e. g. in neighbourhood small block heat and powerplants) is a use advised against.

 

 

 

Rigorous containment measures:

The substance is manufactured and used under strictly controlled conditions over the entire lifecycle. Transport, storage tanks, reactors and processing equipment operate in fully closed systems.

Procedural and control technologies are used to minimise residual emissions/exposure as well as qualitative risk considerations:

Operational and technical conditions and measures affecting and controlling workers exposure, as well as personal protective equipment, such as goggles, chemically resistant gloves, and respiratory protection where potential exposure may occur as reported in the CSR are followed (see chapters 9 & 10).

On the basis of the described process conditions, testing of the distillation residue in teratogenicity study was not performed since the criteria of exposure based adaptation of information requirements are met.