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:

In a guinea pig maximisation test, a group of 20 animals were induced by an intradermal injection of 20% Chloroparaffin 40G (a C14-17 chlorinated paraffin; 40% chlorination, containing 1% epoxy stabilizer) and a subsequent topical application of the undiluted test material. At topical induction, the undiluted material produced "an intense, sometimes haemorrhagic, purulent inflammation", most likely associated with pre-treatment with Freund's Adjuvant. The initial challenge was with undiluted material and the second challenge with a 50% solution in maize oil. Following initial challenge, one test and one control animal produced a reaction at 48 h, with a score of 1 and 3 respectively. No skin response was seen after the second challenge (Murmann, 1988). In addition, no skin sensitisation reactions were seen in two other guinea pig maximisation tests conducted with Meflex DC024 and Meflex DC029 (C14-17 chlorinated paraffins; 40-45% chlorination respectively, containing 0.2% epoxy stabiliser) (Chater, 1978).

 

No data are available on skin sensitisation potential in humans. Overall, the available data on MCCPs and the generally unreactive nature of MCCPs (and data on SCCPs) indicate an absence of skin sensitisation potential.


Migrated from Short description of key information:
No evidence of a skin sensitisation potential was reported in three guinea pig maximisation tests using diluted C14-17 chlorinated paraffins (40 or 45% chlorination, containing 0.2 or 1% epoxy stabiliser).

Respiratory sensitisation

Endpoint conclusion
Additional information:

Not expected to be respiratory sensitisers.


Migrated from Short description of key information:
There are no data relating to respiratory sensitisation in humans or laboratory animals. However, the generally unreactive nature of this group of substances and the lack of skin sensitisation potential suggests that they do not possess the potential to cause such an effect.

Justification for classification or non-classification

Based on the available data, MCCPs would not be classified as a skin or respiratory sensitiser under EU CLP or DSD regulations.