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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Treated distillate aromatic extracts (TDAEs) are a further processing of distillate aromatic extracts (DAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from DAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). Where treatment was sufficient to reduce the 3-7 ring PACs (<3 wt% DMSO extractables as measured by IP-346), the material is most similar to a lubricating base oil and it is this data that should be used for read across. 

TDAEs (IP 346 ≥ 3 wt%)

In a read-across dermal sensitisation study using light paraffinic distillate solvent extract in paraffin oil, male guinea pigs were tested in irritation, induction, and challenge tests to determine if distillate aromatic extracts are delayed dermal sensitizers (API, 1986a). A very slight erythema reaction was exhibited by 8 animals in the test group; however, these reactions did not exceed the highest reaction of the naïve control animals or the irritation exhibited in the test animals during the induction treatment. The other two test animals exhibited no reaction. Based on these findings, DAEs are not delayed contact dermal sensitizers.

 

Additional data support that DAEs are not skin sensitisers (ARCO, 1982c; ARCO, 1984d, e, f; ARCO, 1985c). This information is presented in the dossier.

TDAEs (IP 346 < 3 wt%)

In a key dermal sensitisation study (API, 1982a) 1.0 mL of test substance solvent dewaxed light paraffinic oil (CAS 64742-56-9, sufficiently refined, IP 346 < 3%) was applied to shaved skin of Hartley Albino guinea pigs under occlusive dressing once per week for three weeks with each exposure lasting 6 hours.  The challenge dose (1.0 mL test material) occurred two weeks after the last induction dose.  The challenge mean Draize scores were zero for erythema and oedema; therefore, solvent dewaxed light paraffinic oil was not considered to be a dermal sensitizer. 

In a study conducted with human volunteers (ExxonMobil Biomedical Sciences, Inc., 1988d), 112 human adults were dermally exposed to 0.2 mL of severely hydrotreated heavy naphthenic distillate (IP 346 < 3%) once a day, 4 days a week, for 13 exposures. A challenge phase was conducted where the participants were treated with 0.2 mL once a day, 4 days a week, for 1 week.  The test substance was considered not sensitising due to the small number of slight or mild irritation responses recorded. 

Supporting data from studies conducted in guinea pigs (API, 1982b; 1982c; 1982d; 1982e; 1982f; 1982g; 1986b; UBTL, 1984j, 1984k, 1984l; 1984m; 1984n; 1984o; and Trimmer et al. 1989) and human volunteers (ExxonMobil Biomedical Sciences, Inc., 1988e; 1988f; 1988g) demonstrate that sufficiently refined other lubricant base oils (IP 346 < 3%) are not dermal sensitizers.


Migrated from Short description of key information:
Read across studies conducted with distillate aromatic extracts (equivalent to OECD 406) or other lubricating base oils (IP 346 <3%; OECD 406) were found to be non-sensitising in Hartley Albino guinea pigs.

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

Based on read-across skin sensitisation data from DAEs and OLBOs (IP 346 < 3%), TDAEs (both IP ≥ 3% or <3%) do not meet the criteria for classification as dermal sensitisers under the EU CLP Regulation (EC No. 1272/2008).