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:

The skin sensitization potential of the read-across substance hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics, was studied in a guinea pig maximization test (Magnusson/Kligman method) similar to OECD 406. Guinea pigs (10/sex in treated group and 5/sex in control group) were induced with 1% (w/v) of the test substance in corn oil as a 0.1 ml injection in the shaved shoulder region. Six to eight days later a topical induction of 50% (w/v) test material was applied under an occlusive dressing for 48 hrs. On Day 20-21 guinea pigs were challenged with 25% (w/v) test material applied to the shaved flank. Skin response was evaluated immediately after challenge, and 24 and 48 hours later. The test substance did not cause indication of skin sensitization in any guinea pig at any evaluation period after challenge (Shell Chemicals, 1977).

Migrated from Short description of key information:
The available data on the skin sensitisation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics support the conclusion that the registered substance hydrocarbons, C7-C8, n-alkanes is not a skin sensitiser.

Justification for classification or non-classification

Before the current ECHA nomenclature rules became effective, we adopted the IUPAC name Hydrocarbons, C7-9, n-alkanes, isoalkanes, cyclics (EC number 920-750-0) as the identifier for the substance and this was the name that was used during the pre-registration phase of REACH. Also during this time, samples of the product were collected and the required physicochemical studies were conducted. The resulting robust studies summaries were entered into the IUCLID dossier using this name and EC number.

Between 2008 and 2009 ECHA issued a specific document about the nomenclature to be used under REACH, the so called REACH Implementation Project 3.10. The implications of this document to the appropriate nomenclature for the registered substance were only fully understood by us beginning in late 2009/early 2010.

As such, during the creation of the robust study summaries in IUCLID, the discrepancy with the substance naming was not noticed. As a result, it appears in IUCLID that the tested substance indicated is not the same as the registered one; however, if robust study summaries and/or associated study reports use the substance name “Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics,” they are actually referring to the registered substance “Hydrocarbons, C7-C8, n-alkanes” according to the revised REACH nomenclature rules.

The available data on the skin sensitisation potential of hydrocarbons C7-C9, n-alkanes, isoalkanes, cyclics are conclusive but not sufficient for classification of the registered substance hydrocarbons, C7 -C8, n-alkanes.