Registration Dossier

Administrative data

Description of key information

One key study was identified for skin irritation. An unrefined light paraffinic oil was found to cause mild to moderate irritation in rabbits subsequent to an occluded 24 hour dermal exposure. Based on this result it was considered that the material did not meet the criteria for classification as a skin irritant

One key study was identified for eye irritation. An unrefined light paraffinic oil was not found to be irritating to the eyes of rabbits subsequent to ocular exposure.

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

One key study (API, 1986a; Klimisch = 2) was identified for skin irritation. Six, 14 week New Zealand White rabbits were dermally exposed to 0.5 mL of unrefined light paraffinic distillate for 24 hours under occlusion. Both intact and abraded skin was observed for a total of 14 days. Erythema and oedema irritation was scored by the method of Draize. Unrefined light paraffinic distillate was found to cause dermal irritation, 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. The material did not however meet the EU criteria for classification as a skin irritant.

One key study (API, 1986a; Klimisch = 2) was identified for eye irritation. 0.1 mL of unrefined light paraffinic distillate was instilled on to the corneal surface above the everted lower lid of one eye of nine 14 week, young adult, New Zealand White rabbits. The contralateral eye served as the untreated control. Three of the nine rabbits had eyes washed 20 to 30 seconds after instillation while six of the nine rabbit’s eyes remained unwashed. Animals were observed for 7 days and ocular irritation was scored by the method of Draize. One animal died on day 7, but was not considered to be treatment related. The test material did not cause an initial pain response or corneal or iridial irritation. Any observable eye irritation cleared by 48 hours. The test material was not considered irritating by EU classification.

Justification for classification or non-classification

Results of studies in rabbits with an unrefined light paraffinic distillate did not meet the EU criteria [CLP Regulation (EC No. 1272/2008)] for classification as either as a skin or eye irritant. Unrefined/acid treated oils may however cause skin dryness or cracking on repeated or prolonged contact and hence are assigned the supplemental hazard phrase EUH066.