Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Alchisor CAL 145 comprises alkenes C13-14 hydroformylation products with read-across from the chemically-similar Alchisor CAL 123 as defined in the `Read-Across Justification Document'. Where toxicological data exist for Alchisor CAL 123, these are representative of the Alchisor CAL 145 substance.

Skin Sensitisation

In a reliable (Klimsich 1; Klimisch 2 when used for read-across) GLP compliant study conducted according to both OECD 406 and EPA OPPTS 870.2600 guidelines Alchisor CAL 123 was topically applied to 30 short-haired male and female albino guinea pigs.

Test group animals (10/sex) received three pairs of intradermal injections (adjuvant, a solution of test substance in corn oil, and a 50:50 mixture of adjuvant and the test substance solution) followed one week later by a single topical application of the undiluted test substance. Ten additional animals (5/sex) served as a control group. Control animals were treated at the same time periods and locations but with the vehicle used in place of the test substance solution. Two weeks after the topical application, the test animals were challenged with a second topical application of the undiluted test substance at a virgin test site. Control animals were also given a topical application of undiluted test substance. The percentage of animals exhibiting erythema with or without edema after the challenge treatment was used to assign the test substance a sensitization potency rating. Since none of the test animals exhibited scores greater than 0, the test substance Alkenes, C11 -12, hydroformylation products, distn. residues was given a sensitization potency rating of non-sensitizer (Grade 0).

 

It should be noted that during the study, two test animals and one control animal died; deaths were not considered related to substance administration.


Migrated from Short description of key information:
Sensitisation: A reliable (Klimisch 1; Klimisch 2 when used for read-across) GLP compliant guinea pig maximisation test was conducted according to both OECD 406 and EPA OPPTS 870.2600 guidelines with alkenes C11-C12, hydroformylation products, distn residues. In this instance the test substance was reported to be non-sensitising.

Justification for classification or non-classification

These findings do not warrant the classification of alkenes, C11 -12, hydroformylation products, distillation residues (CAS No: 90622 -27 -8) as a sensitiser 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.