Registration Dossier

Administrative data

Description of key information

Results of dermal irritation studies in rabbits indicate that paraffin wax is not irritating to the skin.

Eye irritation studies (OECD 405) conducted with paraffin wax in rabbits demonstrated either no irritation or mild irritation that resolved within 24 to 72 hours.  Microcrystalline wax tested at concentrations up to 100% purity produced no or mild irritation that resolved within 72 hours.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a primary skin irritation study (NOTOX, 2003a), the intact skin of three male New Zealand 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 considered not irritating.

Data from multiple skin irritation studies (NOTOX, 2003b; BIBRA Toxicology International, 1993c; CFTA, 1980a; Elder, 1984; CTFA, 1972a; CTFA, 1972 b; CFTA, 1980b; CFTA, 1977a; CFTA, 1977b; CFTA, 1977c) indicate that paraffin and hydrocarbon waxes are not irritating to the skin of rabbits.

In a primary eye irritation study (SafePharm Laboratories Limited, 2007b), 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 is therefore not considered to be 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.

Data from multiple supporting studies (CFTA, 1980a; CFTA, 1972a; CFTA, 1972b; Elder, 1984; BIBRA Toxicology International, 1993d) indicate that paraffin and hydrocarbon waxes are not irritating when applied to the eyes of rabbits.

Justification for selection of skin irritation / corrosion endpoint:

one of 11 studies showing similar results

Justification for selection of eye irritation endpoint:

one of 8 results showing similar results

Justification for classification or non-classification

Paraffin and hydrocarbon waxes do not meet the criteria for classification as a skin irritant under Annex VI of EU CLP Regulation (EC No. 1272/2008) because the waxes were not observed to be irritating in rabbits and in studies conducted with human volunteers.

Paraffin waxes do not meet the criteria for classification as an eye irritant under Annex VI of EU CLP Regulation (EC No. 1272/2008) because, in general, the waxes were found to be not irritating to eyes of rabbits.

There was no data identified on respiratory irritation.