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Administrative data

Description of key information

Read-across dermal irritation (OECD 404) and eye irritation (OECD 405) studies in animals and humans indicate that sufficiently and insufficiently refined petrolatum are 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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Insufficiently Refined Petrolatum (Carcinogenic or Unknown Feed-stock)

Skin Irritation

No dermal irritation studies have been reported for insufficiently refined petrolatum, but data have been reported for unrefined/acid treated lubricant base oils, materials similar to the oil entrained in insufficiently refined petrolatum.

In a key read-across primary dermal irritation study (API, 1986a), six 14-week-old New Zealand White rabbits were dermally exposed to 0.5 millilitres of API 84-01 for 24 hours. Both intact and abraded skin was observed for a total of 14 days. Erythema and oedema irritation were scored by the method of Draize. In this study, API 84 -01 was found to be a dermal irritant to the skin based on the primary dermal irritation index score of 4.3. Mean erythema and oedema scores over 72 hours (i. e., average of 24 and 72 hour readings) for intact skin was 2.08 for both endpoints. Mean erythema and oedema scores over the same time period for abraded skin were 2.25 and 2.17, respectively. It should be noted however, that the procedure used, i. e. 24-hour exposure period with an occlusive dressing was more severe than the 4-hour exposure period with semi-occlusive dressing which is the basis for dermal irritation classification in the EU. API 84 -01 was therefore not considered to be irritating to the skin of rabbits. Stream 84-01 has a significantly low viscosity (14 cst @ 40°C) and is likely to be more irritating to skin than larger molecular weight molecules in petrolatum.

Eye Irritation 

No eye irritation studies have been reported for insufficiently refined petrolatum, but data has been reported for unrefined/acid treated lubricant base oils, materials similar to the oil entrained in insufficiently refined petrolatum.

In a key read-across primary eye irritation study (API, 1986a), 0.1 milliltres of API 84 -01 (an unrefined/acid treated oil) was instilled into the corneal surface above the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The nine animals treated were 14-week-old, young adult, New Zealand White rabbits. Three of the nine rabbits had eyes washed 20 to 30 seconds after instillation. Six of the nine rabbit’s eyes remained unwashed. Animals were observed for 7 days total. Irritation was scored by the method of Draize. One animal died on day 7, but this was not considered to be treatment-related.  The test material did not cause an initial pain response or corneal or iridial irritation. The eye irritation that occurred had cleared by 48 hours. The test material was not considered to be an ocular irritant.

Sufficiently Refined Petrolatum (Non-carcinogenic Feed-stock)

Skin Irritation

No dermal irritation studies have been reported for sufficiently refined petrolatum, but data have been reported for paraffin and hydrocarbon waxes, materials similar to constituents of severely refined petrolatum.

In a key read-across primary skin irritation study (NOTOX, 2003a), 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 data from studies conducted in rabbits (CTFA, 1972b; 1972c; 1972d; 1977a; 1977b; 1977c; 1980a; 1980b; BIBRA, 1993d; NOTOX, 2003b) have also demonstrated that paraffin wax samples are not irritating to the skin. Additional supporting 24 -hour patch test data from studies conducted with human volunteers (CTFA, 1972e; CFTA, 1972f; 1974; 1977a; 1977b; 1977c; 1980a; 1981a; 1981b; 1981c; Elder, 1984) have also demonstrated that 100% paraffin wax samples and formulations containing paraffin wax 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 acute eye irritation test (CTFA, 1980c), 0.1 millilitres of a 50% paraffin wax in petrolatum solution was instilled into the eyes of six albino rabbits without rinse. The test material was not observed to be irritating to the eye.

Supporting data from tests conducted in rabbits with paraffin wax (BIBRA, 1993e; CTFA, 1972g; 1972h; 1972i; 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 or insufficiently 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 selection of skin irritation / corrosion endpoint:

One of 12 available skin irritation studies.

Justification for selection of eye irritation endpoint:

One of 7 available eye irritation studies.

Justification for classification or non-classification

Based on the available data, sufficiently refined and insufficiently 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 and insufficiently refined petrolatums do not meet the criteria for classification as an eye irritant under Annex VI of EU CLP Regulation (EC No. 1272/2008).