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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Non-human information

A modified Buehler test was performed by White Eagle Toxicology Laboratories (1996) to assess the sensitisation potential of cyclohexane. There was no incidence of sensitisation among cyclohexane induced and challenged animals.

 

A maximisation test was performed by NOTOX (1996) to assess the sensitisation potential of toluene in guinea pigs. It was concluded that toluene was not a skin sensitiser in this study.

 

The major component n-hexane and the minor components styrene and xylenes are similarly considered not to be skin sensitisers.

 

The minor component tert-butylcatechol is considered to be a strong sensitizer (Zimerson et al. 1999).

There is no relevant non-human information on 4-vinylcyclohexane and the minor components ethylbenzene and cycloocta-1,5-diene.

 

Human information

 

From widespread, high tonnage use, there are no reports of skin sensitisation in humans from component substances hexane, cyclohexane and toluene or the minor components 1,3-butadiene and styrene.

 

Data on minor components:

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

Ethylbenzene: As cited in Opdyke (1975), Kligman (1974) reported that ethylbenzene produced no sensitisation reactions in 25 volunteers subjected to a maximisation test with 10% ethylbenzene in petrolatum. The EU RAR (2008a) for ethylbenzene concluded that there are no reports on skin sensitisation caused by the substance at the workplace and there no sensitisation potential is expected.

 

 

Addional References

ATSDR (1999). Toxicological Profile for n-Hexane. http: //www. atsdr. cdc. gov/toxprofiles/tp113. Html

EU (2008a). Draft Risk Assessment Report for Ethylbenzene. http://echa.europa.eu/doc/trd_substances/ethylbenzene/rar/trd_rar_germany_ethylbenzene.pdf

Opdyke DLJ (1975). Monographs on fragrance raw materials. Food Cosmet Toxicol 13: 803-804


Migrated from Short description of key information:
There are no sensitisation data on the intermediate.
The major and minor components are not strong skin sensitisers. This is supported by the lack of human case reports for high tonnage and wide use of the component substances.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
No specific animal or human data have been found with regard to respiratory sensitisation for any components within this intermediate and there are no chemical or structural indications that components are respiratory allergens.

Justification for classification or non-classification

There are sufficient data on the major and minor component substances present to indicate that the intermediate is unlikely to be a skin or respiratory sensitiser and no classification is warranted for these endpoints under Dir 1999/45/EC or Reg (EC) 1272/2008.