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Description of key information

The key dermal irritation studies were identified as API (1982a).  Sufficiently refined other lubricant base oils (IP 346 < 3%) were not observed to be skin irritants when applied dermally to the skin of rabbits for 24-hours (mean erythema and oedema scores were 0.17 and 0, respectively at 72 hours).

In the key studies were identified for eye irritation, solvent dewaxed light paraffinic oil (IP 346 < 3%) was classified as not irritating.

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

Multiple studies were available to assess the skin irritation potential of other lubricant base oils.

A key primary dermal irritation study (API, 1982a) was identified to evaluate the skin irritation potential of sufficiently refined other lubricant base oils (IP 346 < 3%). In this primary dermal irritation study, 6 New Zealand White rabbits (3 male/3 female) were dermally administered 0.5 mL solvent dewaxed light paraffinic oil (CAS No. 64742-56-9) under occlusive wrap for 24-hours. After the exposure period, the bandages were removed and test sites were wiped with gauze sponges. The animals were observed thereafter and dermal irritation was scored using the method of Draize at 24 hours, 72 hours and on Day 7 post-exposure.

Oedema was not apparent in male or female rabbits at any observation point. Very slight erythema (1) was evident in all male and female rabbits at the 24 hour observation point. Very slight erythema (1) was observed in only 1 male rabbit by the 72 hour observation point and no irritation was visible in any test animal by the end of the 7-day observation period. No differences in irritation were observed between intact and abraded skin sites. Solvent dewaxed light paraffinic oil was not considered to be irritating to the skin of rabbits.

Supporting data from studies conducted in rabbits (API, 1982b; 1982c; 1982d; 1982e; 1982f; 1982g; 1986b; UBTL, 1984a; 1984b; 1984c; 1984d; 1984e;; Trimmer et al. 1989) and humans (Exxon Biomedical Sciences, Inc., 1988d). demonstrate that sufficiently refined other lubricant base oils (IP 346 < 3%) are either only weakly irritating or not irritating to the skin of rabbits and humans.

Eye Irritation

Multiple studies were available to assess the eye irritation potential of other lubricant base oils. 

In a primary eye irritation study (API, 1982a), 0.1 millilitres of solvent dewaxed light paraffinic oil (CAS 64742-56-9, IP 346 < 3%) was instilled in the eyes of New Zealand White rabbits with and without a 30-second rinse.  A single male rabbit in the no-rinse group showed conjunctival chemosis at 48 hours which resolved by 72 hours. No rabbits in the washed group exhibited irritation; therefore, dewaxed light paraffinic oil is not considered an eye irritant.

Supporting data from studies conducted in rabbits (API, 1982b; 1982c; 1982d; 1982e; 1982f; 1982g; 1986b; UBTL, 1984f; 1984g; 1984h; 1984i;) demonstrate that sufficiently refined other lubricant base oils (IP 346 < 3%) are not ocular irritants.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin Irritation

Multiple studies were available to assess the skin irritation potential of other lubricant base oils.

A key primary dermal irritation study (API, 1982a) was identified to evaluate the skin irritation potential of sufficiently refined other lubricant base oils (IP 346 < 3%). In this primary dermal irritation study, 6 New Zealand White rabbits (3 male/3 female) were dermally administered 0.5 mL solvent dewaxed light paraffinic oil (CAS No. 64742-56-9) under occlusive wrap for 24-hours. After the exposure period, the bandages were removed and test sites were wiped with gauze sponges. The animals were observed thereafter and dermal irritation was scored using the method of Draize at 24 hours, 72 hours and on Day 7 post-exposure.

Oedema was not apparent in male or female rabbits at any observation point. Very slight erythema (1) was evident in all male and female rabbits at the 24 hour observation point. Very slight erythema (1) was observed in only 1 male rabbit by the 72 hour observation point and no irritation was visible in any test animal by the end of the 7-day observation period. No differences in irritation were observed between intact and abraded skin sites. Solvent dewaxed light paraffinic oil was not considered to be irritating to the skin of rabbits.

Supporting data from studies conducted in rabbits (API, 1982b; 1982c; 1982d; 1982e; 1982f; 1982g; 1986b; UBTL, 1984a; 1984b; 1984c; 1984d; 1984e;; Trimmer et al. 1989) and humans (Exxon Biomedical Sciences, Inc., 1988d). demonstrate that sufficiently refined other lubricant base oils (IP 346 < 3%) are either only weakly irritating or not irritating to the skin of rabbits and humans.

Eye Irritation

Multiple studies were available to assess the eye irritation potential of other lubricant base oils. 

In a primary eye irritation study (API, 1982a), 0.1 millilitres of solvent dewaxed light paraffinic oil (CAS 64742-56-9, IP 346 < 3%) was instilled in the eyes of New Zealand White rabbits with and without a 30-second rinse.  A single male rabbit in the no-rinse group showed conjunctival chemosis at 48 hours which resolved by 72 hours. No rabbits in the washed group exhibited irritation; therefore, dewaxed light paraffinic oil is not considered an eye irritant.

Supporting data from studies conducted in rabbits (API, 1982b; 1982c; 1982d; 1982e; 1982f; 1982g; 1986b; UBTL, 1984f; 1984g; 1984h; 1984i;) demonstrate that sufficiently refined other lubricant base oils (IP 346 < 3%) are not ocular irritants.