Ethene, homopolymer, oxidized, hydrolyzed, distn. residues, from C16-18 alcs. manuf.

Endpoint summary

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
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

Value:

mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Value:

mg/kg bw

Additional information

Ziegler Bottoms are characterized as comprising of two primary constituents; icosan-1-ol and docosan-1-ol. Together these constituents represent a structural class of components (alcohols) that constitute approximately 82% of the composition of Ziegler Bottoms. Study data, where available, for each of these primary constituents has been evaluated and considered together. In a conservative approach the most sensitive study result from across the two constituents has 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 2) study the acute oral toxicity of docosan-1-ol was assessed. Thiws 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. Consequently in line with the read-across justification included, Ziegler Bottoms are considered to be of low acute oral toxicity with an LD50 >2000mg/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 Ziegler Bottoms 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, Ziegler Bottoms are considered to be of low acute dermal toxicity with an LD50 >20ml/kg

Inhalation

Physio-chemical properties of the Ziegler Bottoms can be used to assess whether there is a necessity for acute inhalation toxicity testing. In this instance the Ziegler Bottoms are of low volatility with a measured vapour pressure < 0.001 mm Hg at 38°C. Consequently acute inhalation toxicity testing for this test item is not required.

Justification for classification or non-classification

On the basis of read across data, the test substance, Ziegler Bottoms 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 Ziegler Bottoms under the new 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).