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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate EU guideline and in compliance with GLP. The study is read across from 1-octadecanol (CAS 112-92-5).
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
other:
Strain:
Dunkin-Hartley
Route:
epicutaneous, occlusive
Vehicle:
other: arachis oil
Route:
epicutaneous, occlusive
Vehicle:
other: arachis oil
No. of animals per dose:
10
Details on study design:
1st application: Induction 1 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge occlusive epicutaneous

RESULTS OF PILOT STUDY: Minimal erythema at 24 and 48 hours after 48 hour topical exposure, no irritation at these time periods after a 24 hour 

topical application. Well defined erythema (grade 2) at 24, 48 and 72 hours post injection reducing to slight erythema (grade 1) at 7 days.

RESULTS OF TEST
- Sensitization reaction: No positive responses with 25% or 50% challenge concentrations in test or control groups at 24 or 48 hours. 0/10  treated and 

0/5 controls responded to challenge.
- Clinical signs: Body weights and weight gain over the observation period were comparable in test and control groups. Well-defined erythema was 

noted at the intradermal induction sites of all test group animals at 24 and 48hours. Very slight to well-defined erythema was noted at the 

intradermal sites of the control group at 24 and very slight erythema at 3 sites at 48 hours.
Very slight to well-defined erythema was noted at the induction sites of six test group animals at the 1 hour mark. No skin reactions were noted at 

the induction sites of any test group animals at the 24 hour mark.
- Rechallenge: Not carried out.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Kalcol 8098 is not a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure.
The result is read across from 1-octadecanol (CAS 112-92-5).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Olefines polymer, oxidized, hydrolyzed, distillation residues, are by-products of the C20 alcohols manufacturing process. The substance, ‘Olefines polymer, oxidized, hydrolyzed, distillation. residues, are by-products from C20 alcohols manufacturing’, is a UVCB substance that comprises several linear long chain alcohols, predominantly docosan-1-ol (C22), tetracosan-1-ol (C24), hexacosan-1-ol (C26) and eicosan-1-ol (C20). Together, these constituents make up over 80% of the composition ofOlefines polymer, oxidized, hydrolyzed, distillation. residues, are by-products from C20 alcohols manufacturing. 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.  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.

 

In a reliable (Klimisch 1) OECD 406 GLP compliant study the skin sensitising potential of octadecan-1-ol has been assessed. Octadecan-1-ol data in this instance has been used provide read-across data for the sensitisation endpoint of both icosan-1-ol and docosan-1-ol. In this study octadecan-1-ol was reported to not be a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure. A second reliable (Klimish 1) study following OECD 406 and EU method B.6 guidelines and under GLP compliance examined a mixture of icosan-1-ol and docosan-1-ol in female Dunkin-Hartley guinea pigs. The mixture did not elicit a sensitization response when given a dermal injection of 5% test material concentration in the first week, 75% test material concentration in the second week with a topical application of 10% concentration two weeks after the higher injection. Consequently in line with the read-across justification included, Olefines polymer, oxidized, hydrolyzed, distillation residues, a by-product of C20 alcohols manufacturing, is not considered to be sensitising.


Migrated from Short description of key information:
The key study for sensitisation was a reliable (Klimisch 1) OECD 406 study with octadecan-1-ol. In this study the test substance was reported to be non-sensitising.

A reliable (Klimish 1) study following OECD 406 and EU method B.6 guidelines and under GLP compliance examined a mixture of icosan-1-ol and docosan-1-ol in female Dunkin-Hartley guinea pigs and found to mixture to be not-sensitising .

Justification for selection of skin sensitisation endpoint:
This reliable Klimisch 1 study follows EU guidelines and is GLP compliant. Octadecan-1-ol was not reported a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

These findings do not warrant the classification of Olefines polymer, oxidized, hydrolyzed, distillation residues, a by-product of C20 alcohols manufacturing, as a sensitiser under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) and under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.