Registration Dossier

Administrative data

Description of key information

Oral
• A reliable (Klimisch 1) OECD 401 GLP compliant study with icosan-1-ol. LD50 >10000mg/kg
• A reliable (Klimisch 1) OECD 423 GLP compliant study with docosan1-1ol. LD50 >2000mg/kg
• A reliable (Klimisch 2) guideline equivalent oral study was conducted with D-002 in New Zealand rabbits and beagle dogs. The LD50 >5000 mg/kg
Dermal
• A reliable (Klimisch 2) guideline equivalent acute dermal study was conducted with icosan-1ol in rabbits. The LD50 >20mL/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
All experimental animals survived the 14-day test period. There were no clinical signs of toxicity, no body weight gain, and necropsy findings were unremarkable.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
20
Quality of whole database:
New Zealand White male rabbits were tested for acute toxicity via the dermal route. After adjusting for density, the LD50 was >20 mL/kg.

Additional information

Alcohols, C20-30 (even numbered), is a UVCB substance that comprises several linear long chain alcohols, predominantly tetracosan-1-ol (C24), hexacosan-1-ol (C26), and octacosan-1-ol (C28). Together, these substances make up approximately 70% of the composition of Alcohols, C20-30 (even numbered). Other constituents include, to a much lesser extent, secondary long chain alcohols and complex mixtures of long chain carboxylate esters. On this basis, study data, where available, for each of the long chain alcohol constituents has been evaluated and considered together; this is consistent with the Category approach applied for Long Chain Alcohols (LCA) under REACH. 

Available data for D-002, a defined mixture of higher aliphatic alcohols (triacontanol, octacosanol, dotriacontrianol, hexacosanol, tetracosanol) isolated from beeswax, has also been considered in this evaluation. In a conservative approach the most sensitive study result from the constituents of the LCA category have been identified and used to address the endpoint in question.

 

Oral

In a reliable (Klimisch 1) OECD 401 GLP compliant study the acute oral toxicity of icosan-1-ol was evaluated. The rat oral LD50 for icosano1-ol was reported as >10g/kg. At this dose level there was no evidence of toxicity in any of the parameters monitored.

 

In a second reliable key (Klimisch 1) study the acute oral toxicity of docosan-1-ol was assessed. This OECD 423 GLP compliant study reported that no signs of intoxication were found and no remarkable findings on gross necropsy were noted. The LD50 reported in this study was >2000mg/kg.

 

A third reliable key (Klimisch 2) study analysed D-002 in rabbits and beagles. This guideline equivalent oral study found no significant effects to mortality, clinical signs, body weight or histopathology. The reported LD50 in both animals was >5000 mg/kg.

 

Consequently in line with the read-across justification included, Alcohols, C20-30 (even numbered), is considered to be of low acute oral toxicity with an LD50 >10g/kg.

 

Dermal

A reliable (Klimisch 2) key study is reported in support of the acute dermal toxicity evaluation of icosan-1-ol. In addition to providing support for the acute dermal endpoint of Alcohols, C20-30 (even numbered), this data is used to read across to the acute dermal endpoint for docosan-1-ol. In this guideline equivalent study the LD50 was reported to be >20ml/kg. Consequently in line with the read-across justification included, Alcohols, C20-30 (even numbered), is considered to be of low acute dermal toxicity with an LD50 >20ml/kg

 

Inhalation

Physio-chemical properties of Alcohols, C20-30 (even numbered), can be used to assess whether there is a necessity for acute inhalation toxicity testing. In this instance low volatility with a measured vapour pressure < 0.001 mm Hg at 38°C does not require acute inhalation toxicity testing for this test item.

 

 


Justification for selection of acute toxicity – oral endpoint
This reliable Klimish 1 study follows the OECD 401 guidelines and is in compliance with CLP. Male and female Sprague Dawley rats were dosed and followed for 14 days to examine acute effects.

Justification for selection of acute toxicity – dermal endpoint
This reliable Klimish 2 study meets the generally acceptable scientific principles and is acceptable for assessment.

Justification for classification or non-classification

On the basis of read across data, the test substance, Alcohols, C20-30 (even numbered), is of low acute toxicity via ingestion (oral LD50 >10g/kg) or via dermal exposure (dermal LD50 >20ml/kg). These findings do not warrant classification of Alcohols, C20-30 (even numbered), under

Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) and do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD).