Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

In the end nineties Deretil has noticed that in particular esters resulted in positive M&K tests, whereas the practice did not show any effect.

Deeper analysis by an expert and of existing studies revealed that the use of corn oil could be the cause of that.

Therefore we decided to redo the test for HPGM with 1% aqueous carboxymethylcellulose.

(corn-) oil gives sooner positive GPMT responses compared to Propylene Glycol (PG).

Migrated from Short description of key information:
Maximisation (OECD 406, GLP) (Pels Rijcken WR, Notox, 2000): negative (vehicle = 1% aqueous carboxymethyl cellulose) (key study)
Buehler test (OECD 406, GLP) (Pels Rijcken WR, Notox, 2000): negative (vehicle = 1% aqueous carboxymethyl cellulose) (supporting study)
Maximisation (OECD 406, GLP) (Pels Rijcken WR, Notox,1996): positive (vehicle =corn oil) (not reliable)

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data available

Justification for classification or non-classification

Data are conclusive for skin sensitisation, but not sufficient for classification according to CLP criteria (Regulation (EC) No 1272/2008). No data is available by inhalation.

No classification is proposed for sensitisation according to CLP.