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:

For purposes of classification and labelling and registration under REACH, aromatic extracts are sub-divided into the categories of distillate aromatic extracts (DAE), treated distillate aromatic extracts (TDAE), and residual aromatic extracts (RAE). Some of the classifications are based on 3-7 ring PAC content, which is not substantively affected by whether the aromatic extract is derived from paraffinic or naphthenic or “light” or “heavy” crude. Therefore, DAEs and RAEs are not subclassified based on crude oil source or viscosity. For most health endpoints, data from any one of the DAEs can be “read-across” to the remaining DAEs and whole RAE category. 

In a read-across dermal sensitisation study using light paraffinic distillate solvent extract in paraffin oil, 5 to 6 week old Hartley guinea pigs were tested in a Buehler test which is similar to OECD test guideline 406. 10 test guinea pigs were dosed with 0.4 mL 50% v/v in paraffin oil for 3 weeks (1 dose/week) and then a challenge dose of 0.4 mL 1% v/v in paraffin oil 2 weeks after the last test dose. A naïve control group of 10 animals remained untreated during induction, but received the same dose as the test animals during the challenge phase. A very slight erythema reaction was exhibited by 8 animals in the test group. These reactions did not exceed the highest reaction of the naïve control animals. The other two test animals exhibited no reaction. 

 

Based upon the similar results obtained from the challenge phase and the naive control, RAEs are not sensitising to guinea pig skin according to EU criteria. 

Migrated from Short description of key information:

Distillate aromatic extracts were found to be non-sensitising in Hartley guinea pigs when utilising the Buehler test (equivalent to OECD 406) and based on read across, RAEs are not expected to cause skin sensitisation.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Respiratory sensitisation is not a standard information requirement.

Migrated from Short description of key information:

No data identified.

Justification for classification or non-classification

Distillate aromatic extracts are not considered skin sensitisers based on the information presented above. Since read across from DAE is considered appropriate for this endpoint, RAEs do not meet the criteria for classification as a dermal sensitiser under CLP Regulation, (EC)1272/2008,

according to the read-across strategy.