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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Light paraffinic DAE (CAS number 64742-05-8) was tested on 10 Hartley guinea pigs for sensitization in a Buehler test. The procedure used was a closed patch test closely following the Buehler test method outlined in OECD Guideline 406. The animals were divided into six groups: test group (10), naïve control group (10), vehicle control (10), positive control (20) and finally a naïve positive control group (20). In the test group (8/10) animals displayed very slight erythema; the highest reaction did not exceed the highest reaction of the naïve control animals. No reaction was observed in 2/10 animals. Animals in the naïve control group (9/10), vehicle control group (3/10), displayed very slight erythema. No reaction was seen in the rest of animals in each group. The positive control group (20/20) showed slight to severe irritation. The reactions of all animals equalled or exceeded the highest reaction observed in the naïve positive control group (4/19). Since the challenge reactions of the test animals did not exceed the highest reactions of control animals in any of the two naïve groups, it was concluded that the test substance was not sensitizing.

Additional data supports that DAE is not a skin sensitiser (ARCO, 1982c; ARCO, 1984d, e, f; ARCO, 1985c). This information is presented in the dossier.

Migrated from Short description of key information:

Distillate aromatic extracts were found to be non-sensitising in Hartley guinea pigs when utilizing the Buehler test (equivalent to OECD 406).

Justification for selection of skin sensitisation endpoint:

One of six studies showing similar results

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Distillate aromatic extracts are not considered skin sensitizers based on results form a number of studies in guinea pigs . Therefore, distillate aromatic extracts do not meet the criteria for classification as dermal sensitizers under the EU CLP Regulation (EC No. 1272/2008). There are no data available for respiratory sensitisation.