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:

Non human data

The sensitisation potential of E000044012 [CAS 68478-10-4] (UBTL, 1990p), E000044146 [CAS 68478-10-4] (UBTL, 1990q), and E000144700 [CAS 68516-20-1] (UBTL, 1990r) was investigated in guinea pig studies. For each substance dermal exposure to a 1:2 dilution of 0.5 mL in mineral oil was used for each of 3 induction phases and a 1:4 dilution was used for challenge. Response grades, severity and incidence were not greater than those at the control group site and all three streams were considered not to be skin sensitisers.

The components dicyclopentadiene, benzene, 1,3-butadiene, isoprene, toluene, naphthalene, styrene, xylenes and ethylbenzene are considered not to be skin sensitisers.

Human data

Human data identified was for benzene and xylenes:

Benzene (No classification): In a study using 25 male volunteers a maximisation test with induction using 50% benzene and challenge with 20% benzene no evidence of skin sensitisation was seen (Kligman, 1966).

Xylene (No classification): In a human maximization test (Kligman, 1966), xylene was tested at 100% and subjects were challenged at 25%. No skin sensitisation resulted.

References

Kligman AM (1966). The identification of contact allergens by human assay. III The maximization test: a procedure for screening and rating contact sensitizers. J Int Dermatol, 47 (5), 393-409.


Migrated from Short description of key information:
Resin Oils and Cyclic Dienes are considered not to be skin or respiratory sensitisers. Specific data for three streams, E000044012 [CAS 68478-10-4], E000044146 [CAS 68478-10-4], E000144700 [CAS 68516-20-1] indicated no skin sensitisation in guinea pig assays. The components dicylcopentadiene, benzene, 1,3-butadiene, isoprene, toluene, naphthalene, styrene, xylenes and ethylbenzene are considered not to be skin sensitisers.

Respiratory sensitisation

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

No specific animal or human data have been found with regard to respiratory sensitisation for any components within this stream.


Migrated from Short description of key information:
No data have been found concerning respiratory sensitisation and there are no indications that components within this stream are respiratory allergens.

Justification for classification or non-classification

There are sufficient data on E000044012 [CAS 68478-10-4], E000044146 [CAS 68478-10-4], E000144700 [CAS 68516-20-1] and on component substances to indicate that Resin Oils and Cyclic Dienes are not skin sensitisers. Although there are no specific data on respiratory sensitisation of Resin Oils and Cyclic Dienes streams or marker components there are no indications that components within this stream are respiratory allergens. It is proposed that no classification is warranted for these end-points under Dir 1999/45/EC or Reg (EC) 1272/2008.