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

Endpoint summary

Description of key information

A subchronic orientating study (13 weeks, rat, gavage) conducted 1980 according to an in house protocol (Henkel R 9500428, 1980) is available. Since the study was conducted prior to the implementation of currently acknowledged testing guidelines (OECD TG 408), current testing requirements are not fulfilled; nevertheless the study provides suitable basic data, acceptable for assessment of the toxic potential of the compound following repeated dosing. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

250 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Additional information

Exposure based adaptation of information requirements:

According to REGULATION (EC) No 1907/2006, Annex IX and Annex X, repeated dose 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 repeated dose 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 a sub-chronic toxicity study (OECD 408) was not performed since the criteria of exposure based adaptation of information requirements are met.

One study of a read across substance gives indication of no toxicity after repeated exposure. A repeated dose study was conducted using Wistar rats (Henkel R 9500428). The study was conducted prior to the implementation of acknowledged guidelines, and thus, does not fulfill all today's requirements for the testing of oral repeated dose toxicity. One group of 30 male and 30 female Wistar rats was given and oral dose 250 mg/kg bw/d of the test item in 1% CMC, by gavage, once a day, 5 days a week, over 12 -13 weeks. A further group of 30 male and 30 female animals was treated similarly but with the vehicle only, and served for control. An additional control group with 20 male and 20 female animals was added, which was used for blood sampling at test initiation. All animals were examined for mortality, clinical symptoms, body weight and body weight gain, haematological and clinical chemical parameters, and urine parameters. At test ending, all animals were sacrificed for the purpose of necropsy, which included gross pathology, organ weighing and histopathology.

Neither mortalities nor clinical symptoms indicative of toxicity were noticed, and no treatment-related changes in body weight and body weight gain were recorded. Regarding haematology, changes in haematocrit and MCV were reported, which however were not considered to be treatment-related as the measured values were within the range considered as normal for the strain used and the age of the animals. Regarding clinical chemistry, a weak increase in alanine aminotransferase (GPT) and a more significant

increase in aspartate aminotransferase (GOT) were reported for treated females but not for the males. These changes, especially for GOT, were considered to be related to treatment, but were not considered to represent adverse effects, since no corresponding changes in liver weight and/or histology were noticed. Urinalysis, feces excretion, organ weights, gross pathology and histopathology showed no changes/lesions which could be attributed to the treatment.

Thus, based on the results reported above, and since no clear treatment-related effects could be evidenced for the test item at the dose level of 250 mg/kg bw/d, the No-Observed-Adverse-Effect-level (NOAEL) was set at 250 mg/kg bw/day.

Justification for classification or non-classification

Based on the available data, no classification according to the EU Directive 67/548/EEC and the CLP Regulation (EC) No. 1272/2008 is needed for "alcohols, C6-C24 and C6 -C24 unsat., distn residues" (CAS 102242 -48 -8).