Hydrocarbon waxes (petroleum), oxidized, calcium salts

Endpoint summary

Description of key information

Skin irritation = Not irritating, male/female rabbit, EPA OPPTS 870.2500, Hoff 2001
Eye irritation = Not irritating, male rabbit, EPA OPPTS 870.2400, Cerven 2001

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

Skin Irritation

Key Study
In the key study, the skin irritation potential of a structural analogue was determined in accordance with the standardised guideline EPA OPPTS 870.2500.

Three New Zealand White rabbits received a single four hour semi-occluded application of 0.5 mL of the test material and were assessed for the following 3 days for any signs of skin irritation. Erythema was barely perceptible at 60 minutes following patch removal, barely perceptible to well defined at 24 hours, absent to barely perceptible at 48 hours and absent at 72 hours. Oedema was absent to barely perceptible at 60 minutes and 24 hours following patch removal, and absent at 48 and 72 hours. There were no abnormal physical signs noted during the observation period and all bodyweight changes were normal.

Under the conditions of the test, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant in accordance with EU criteria.

 

Supporting Information

In the supporting study (Anonymous, 1980b), the skin irritation potential of a structural analogue was determined in accordance with the Code of Federal Regulations, Title 16, Chapter IIc, paragraph 1500.41.

During the study six New Zealand Albino rabbits received a single 24 hour occluded application of 0.5 mL of test material to abraded and unabraded skin; following application, they were assessed for any signs of skin irritation over a 72 hour period. All of the animals tested had slight erythema on the abraded sites and two out of the six animals had slight erythema on the unabraded sites after 24 hours. No erythema was present in any animal after 72 hours. No oedema was noted in any animal on either the abraded or unabraded sites at any time.

Under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant in accordance with EU criteria.

 

Eye Irritation

The eye irritation potential of a structural analogue was determined in accordance with the standardised guideline EPA OPPTS 870.2400.

During the study, 0.1 mL of test material was applied into one eye of three New Zealand White rabbits; the animals were assessed for 72 hours to determine the grade of ocular reaction.

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, which was noted in all three treated eyes, had fully cleared by 72 hours.

Under the conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant in accordance with EU criteria.

 

The available data is considered to be complete and the conclusion for both skin irritation and corrosion and eye irritation, not irritating, was taken forward for risk assessment. The studies were conducted on an analogous substance and therefore are considered as "read-across". Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.

Justification for selection of skin irritation / corrosion endpoint:
The study reported by Hoff was selected as the key study since it was conducted to GLP and in line with the standardised guideline EPA OPPTS 870.2500. As such, the study was assigned a reliability score of 2 according to the criteria of Klimisch (1997) and considered suitable as an accurate reflection of the test material. The study was conducted on an analogous substance and therefore is considered as "read-across". Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.

Justification for selection of eye irritation endpoint:
Only one study is available. The study was conducted to GLP and in line with the standardised guideline EPA OPPTS 870.2400. As such, the study was assigned a reliability score of 2 according to the criteria of Klimisch (1997) and considered suitable as an accurate reflection of the test material. The study was conducted on an analogous substance and therefore is considered as "read-across". Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.

Justification for classification or non-classification

Skin

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for skin irritation.

Eye

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for eye irritation.