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

CAS 68516-20-1 (E000144700) was not a sensitiser in albino guinea pigs dermally exposed to a 1:2 dilution of E000144700 at a volume of 0.5 mL for 3 induction phases and to a 1:4 v/v dilution (in mineral oil) for the challenge (UBTL, 1990e). Similarly the related streams API 83-04 [light catalytic reformed naphtha] and API 83-05 [catalytic reformed naphtha] were negative in Buehler assays for contact sensitisation (API, 1986a).API 83-04 (CAS 64741-63-5) and API 83-05 (CAS 68955-35-1) are two petroleum based naphthas comprising up to 100% aromatics, including substituted mono and di-aromatics with approximately 2-5% benzene and are considered appropriate for read-across to high benzene naphthas.

The components benzene, toluene, hexane, xylenes, 1,3 butadiene, naphthalene, isoprene and anthracene 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:
High Benzene Naphtha streams are considered not to be skin or respiratory sensitisers. Specific data for one stream (CAS 68516-20-1) and 2 related streams (API 83-04 [light catalytic reformed naphtha] and API 83-05 [catalytic reformed naphtha] indicated no skin sensitisation in guinea pig assays. The components benzene, toluene, hexane, xylenes, 1,3 butadiene, naphthalene, isoprene and anthracene 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 CAS 68516-20-1, API 83-04 [light catalytic reformed naphtha], API 83-05 [catalytic reformed naphtha] and on component substances to indicate that High Benzene Naphtha streams are not skin or respiratory sensitisers and no classification is warranted for these endpoints under Dir 1999/45/EC or Reg (EC) 1272/2008.