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Endpoint summary

Description of key information

Available data for multiple constituents of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) provide some evidence of skin and eye irritation with controlled exposures to liquid test substances.

Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) was formerly a member of the LOA Category L (Resin Oils and Cyclic Dienes), and the following Category L streams, with which these studies were conducted, resemble Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) from a compositional standpoint, only containing much lower levels of benzene.

For category L five streams and dicyclopentadiene, benzene and toluene, the effects are such that it is considered that Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) should be considered to be skin irritant and to be labelled appropriately. One category L stream with similar composition (E000044012 [CAS 68478-10-4]) and the constituents DCDP and benzene produce eye irritation of a severity that warrants labelling for eye irritation results. In studies in rabbits, benzene is irritating to the skin and eye but is not considered to be corrosive. In humans high concentrations of benzene vapours are irritating to the mucous membranes of the eyes, nose, and respiratory tract.

Liquid benzene on direct contact with the skin may cause erythema and defatting.

Based on composition of Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) it is proposed that is labelled as an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Data on the components benzene, DCPD and toluene indicate that Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) should be classified as Skin Irrit. 2 H315: Causes skin irritation and Eye Irrit. 2 H319:Causes serious eye irritation.

 

3a,4,7,7a-tetrahydro-4,7-methanoindene (DCPD, dicyclopentadiene; classification under GHS/CLP: cat 2 H315: Causes skin irritation, Cat 2 H319:Causes serious eye irritation and Cat 3 for transient target organ toxicity under STOT-RE):

DCPD produced erythema and slight to severe oedema in contact with rabbit, therefore, dicyclopentadiene was a considered to be a moderate irritant of rabbit skin (Safepharm, 1989).

DCPD also resulted in moderate eye irritation, iridial inflammation and conjunctival irritation were present in all cases and corneal dulling in rabbits. Although corneal redness persisted in one animal at 72 hours, all effects were fully reversible within seven days rabbits (Safepharm 1989d).

Whilst there are no specific studies assessing respiratory irritation, laboured/ irregular breathing, nasal discharge and haemorrhagic lungs post mortem were evident in acute inhalation exposures of rats and mice (Bushy Run, 1981) and dose-dependent eye irritation was observed in a variety of species during acute inhalation exposures to neat dicyclopentadiene.

 

Benzene (classification under GHS/CLP: cat 2 H315: Causes skin irritation, cat 2 H319: Causes serious eye):  

Benzene exposure resulted in oedema and erythema in rabbits (Jacobs. 1991). A study by Wolf et al (1956) showed that instillation of benzene into the rabbit eye caused moderate conjunctival irritation and very slight, transient corneal injury.

Liquid benzene on direct contact with the skin may cause erythema and blistering. Skin contact with benzene removes fat from the tissue which may result in the development of a dry, scaly dermatitis if exposure is repeated or prolonged. Additionally, high concentrations of benzene vapours are irritating to the mucous membranes of the eyes, nose, and respiratory tract (EU RAR, 2008).

 

Toluene (classification under GHS/CLP: Cat 2 H315: Causes skin irritation):

LOA is currently reviewing the human and animal data supporting Human Health for Toluene. It is expected to be completed by Q4 2021. The irritation potential of toluene was reviewed and reported in the EU RAR (2003). Toluene is irritating to skin and eyes in animals, however, classification is required only with respect to skin.

In a rabbit study, exposure to toluene caused significant inflammation of the skin as a mean erythema score exceeding 2 was observed (Exxon, 1988). In addition, the inflammation persisted in all test animals at the end of the observation time. No human data have been found, however, the EU RAR (2003) stated “it is well known that toluene has a degreasing effect on the skin. After repeated exposures, toxic contact dermatitis may develop.”

In ocular irritation study, ocular lesions (redness, chemosis) occurred within 72 hours after exposure and, however, the mean score for redness of the conjunctivae and chemosis did not exceed values of 2.5 and 2, respectively (Exxon, 1995). There are no data from direct exposure of human eyes to liquid toluene. A number of human experimental studies in volunteers have investigated reports of eye “irritation” resulting from exposures to toluene in ambient air. These studies indicate that toluene produces subjective sensations of eye irritation at concentrations ≥ 75 ppm (EU RAR, 2003). In a recent study, Muttray et al (2005) exposed twenty healthy men to a constant level of 50 ppm toluene. There was no effect of toluene exposure on "irritation to the eye", "watering eyes" or "blurred vision”. 50 ppm (192 mg/m3) toluene is a NOAEC for eye irritation in humans.

 

In addition to the data presented above on constituents of the UVCB Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich), data are available for UVCBs with similar compositions – these are also produced via similar manufacturing processes and are rich in DCPD and other cyclic olefins, as well as aromatic compounds. Dermal exposure to the following UVCBs: C9 Resin feed (CAS 68477-54-3), E000144700 (CAS 68516-20-1), E000044146 (CAS 68478-10-4), E000044012 (CAS 68478-10-4) and C9 produkt (CAS 94733-07-0); resulted in moderate to severe erythema and oedema (Lyondell 1990l, j, k and b). Therefore, these UVCBs are irritating but not corrosive to skin and warrant classification as cat 2 H315: Causes skin irritation under GHS/CLP. C9 Resin feed (CAS 68477-54-3), E000144700 (CAS 68516-20-1) and C9 produkt (CAS 94733-07-0) have been shown not to be irritating to the rabbit eye and no classification is warranted under GHS/CLP (DSM Kunststoffen 1989d, Lyondell 1990o and BASF 1990c). E000044102 (CAS 68478-10-4) is irritating to the rabbit eye and should be classified as Cat 2A, H319: Causes serious eye under GHS/CLP (Lyondell 1990m).

 

References:

EU (2008b). European Union Risk Assessment Report for Benzene. EC Joint Research Centre. http: //ecb. jrc. ec. europa. eu/documents/Existing-chemicals/RISK_ASSESSMENT/REPORT/benzenereport063. pdf.

EU (2003a). European Union Risk Assessment Report for Toluene. EC Joint Research Centre http: //ecb. jrc. ec. europa. eu/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/REPORT/toluenereport032. pdf

UK HSC (2001). UK HSC Consultation Document on EC Directive 2000/39/EC establishing a first list of indicative occupational exposure limit values at EC level in implementation of council directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. UK Health and Safety Commission. Available from www.hse.gov.uk/condocs.

Justification for classification or non-classification

There are sufficient data on the streams C9 Resinfeed [CAS 68477-54-3]; E000044012 [CAS 68478-10-4]; E000044146 [CAS 68478-10-4]; E000144700 [CAS 68516-20-1]; and C9 Produkt [CAS 94733-07-0] and on the constituents dicyclopentadiene, benzene, toluene and ethylbenzene indicate that they are irritating to skin. It is proposed that Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) is considered to be skin irritants and labelled “Causes skin irritation” Category 2 (H315) according to Reg (EC) 1272/2008.

 

Although of the tested streams only E000044012 [CAS 68478-10-4] produced irritation of a severity to warrant labelling as irritating to rabbit eye, the constituents dicyclopentadine and benzene are classified as eye irritants. It is assumed that the combined concentration of eye irritating substances will normally exceed the cut-off for classification under CLP (≥10%) and, therefore it is proposed that Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) is considered to be eye irritants and labelled as “Causes serious eye irritation” Category 2 (H319) under Reg (EC) 1272/2008.

 

Dicyclopentadiene and xylenes are considered to be respiratory irritants. Since the concentration of dicyclopentadiene is ≥10%, Distillates (Petroleum), steam-cracked, dimerised (C5-12, C10-rich) is required to be classified “May cause respiratory irritation” Category 3 H335 under Reg (EC) 1272/2008''.