Petrolatum (petroleum), oxidized, calcium salt

Endpoint summary

Description of key information

Read-across dermal irritation (OECD 404) and eye irritation (OECD 405) studies in animals and humans indicate that sufficiently petrolatum is not ocular or skin irritants.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritation

 

No dermal irritation studies have been reported for sufficiently refined petrolatum, but data have been reported for paraffin and hydrocarbon waxes, and other lubricant base oils (IP 346 < 3%), materials similar to constituents of severely refined petrolatum.

 

In a key read-across primary skin irritation study (NOTOX, 2003), the intact skin of three male albino rabbits was exposed to 0.5 milligrams of paraffin wax under semi-occlusive conditions for 4 hours. Animals were observed for 72 hours, and skin irritation or corrosion was scored by the method of Draize at 1, 24, 48, and 72 hours. At the end of the 4 -hour test period, excess paraffin wax was removed with water. Slight erythema was observed at 1 hour in all three animals which was fully reversible by 24 hours. Therefore, under conditions of the study, paraffin wax is not considered to be irritating to the skin of rabbits.  

 

Supporting 24 -hour patch test data from studies conducted with human volunteers (CTFA, 1972a; CFTA, 1972b; Elder, 1984) have also demonstrated that 100% paraffin wax samples are not irritating to the skin of humans.

 

Eye Irritation

 

No eye irritation studies have been reported for sufficiently refined petrolatum, but data has been reported for paraffin and hydrocarbon waxes, materials similar to sufficiently refined petrolatum.

 

In a key read-across primary eye irritation study (Safepharm Laboratories, Ltd., 2007), 0.1 millilitres of paraffin wax was instilled into the conjunctival sac of three male New Zealand White rabbits whose eyes were unwashed. Animals then were observed for 72 hours. Irritation was scored by the method of Draize and a modified Kay and Calandra interpretation of the eye irritation test. Results are presented in the Draize method of scoring.

 

Slight conjunctival irritation was observed at 1 and 24 hours after treatment but was fully reversible after the 24 hour timepoint. In this study, paraffin wax was not an eye irritant based on minimal conjunctival irritation (maximum score of 2 based on redness in each animal) at 24 hours which was fully reversible after the 24 -hour observation.     

 

Supporting data from tests conducted in rabbits with 50% paraffin wax in petrolatum (CTFA, 1980a) and 100% microcrystalline wax (Elder, 1984) indicate that paraffin and hydrocarbon waxes are not ocular irritants.

 

Respiratory tract irritation

 

No respiratory tract irritation studies have been carried out in animals or humans with sufficiently refined petrolatum. However, respiratory irritation has not been reported to be associated with exposure to any of these materials. Inhalation exposure to petrolatums is not expected to occur under normal conditions due to the very low vapour pressures of these substances.

Justification for classification or non-classification

Sufficiently refined petrolatums do not meet the criteria for classification as a skin irritant under Annex VI of EU CLP Regulation (EC No. 1272/2008).

Sufficiently refined petrolatums do not meet the criteria for classification as an eye irritant under Annex VI of EU CLP Regulation (EC No. 1272/2008).