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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

A subacute as well as a subchronic oral gavage study were conducted to assess the repeat dose toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). The test item was dosed to rats up to 1000 mg/kg for 28d and 90d, respectively,  with no obvious evidence of toxicity. Consequently a dose of 1000 mg/kg/day was considered to be a No-Observed-Effect-Level (NOEL) in this study.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The repeated dose oral toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4) was assessed in a 28d subacute study according to OECD Guideline 407 and EPA OPPTS guideline 870.3050 and in a 90d subchronic 90d study according to OECD Test Guideline 408 and EPA OPPTS guideline 870.3100.

Both studies were conducted in accordance with the OECD Principles of Good Laboratory Practice.

 

Animals were monitored regularly for viability and for signs of ill health or reaction to the treatment. The following activities were measured and recorded at pre-determined intervals from pretrial until the completion of the study: body weights, food consumption, observations (clinical, detailed functional, standardised arena and cage), functional tests, ophthalmic examinations, haematology, coagulation, clinical chemistry, urinalysis, gross necropsy, organ weights and histopathology.

There were no treatment-related clinical signs throughout the course of both studies. No treatment-related effects were observed during the detailed functional observation investigations. Body weights and food consumption were unaffected by treatment. There were no treatment-related haematology, coagulation or clinical chemistry changes. There were no treatment-related ocular findings and there were no necropsy or histology findings attributed to treatment.

In conclusion, repeat oral administration of alcohols, C18 -22, distillation residues to Han Wistar rats for up to 90 days at dose levels up to 1000 mg/kg/day was considered to be well tolerated with no obvious evidence of toxicity being noted. Therefore, the dose of 1000 mg/kg /day was considered to be a No-Observed-Effect-Level (NOEL) in this study.

Justification for classification or non-classification

These findings do not warrant the classification of alcohols, C18-22, distillation residues as a repeat dose toxicant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.