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Description of key information

In rabbit tests for skin and eye irritation, involving 24-hour application of Santicizer 278, only slight (transient) effects were observed, not sufficient for classification as a skin or eye irritant. Studies only available in a brief summary report (reliability code 4), but data considered adequate for assessment. Additional skin and eye irritation studies on high molecular-weight phthalates provide support for this conclusion (OECD, 2004. Draft SIDS Initial Assessment Report on High Molecular Weight Phthalate Esters (HMWPE) category). 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin and eye irritation studies have been carried out with Santicizer 278 (Younger Laboratories , 1969c,d). Although details of the two studies are only available in a brief summary report (hence they have been assigned reliability code 4), the data are considered adequate for assessment. Human and animal respiratory tract irritation data are not available for Santicizer 278 or members of the high molecular-weight phthalate category. However, as these are not volatile substances, irritation to the respiratory tract is not expected (OECD, 2004. Draft SIDS Initial Assessment Report on High Molecular Weight Phthalate Esters (HMWPE) category).

When undiluted Santicizer 278 was applied (occluded) to the intact skin of one male and two female albino rabbits for 24 hours, barely perceptible redness (with an average maximum score of 0.6 out of a possible 8) was reported in two of the three rabbits examined 24 hours after removal of the test material. No irritation was reported at the other time points in any of the three rabbits. The investigators classed the test material as non-irritating when applied (occluded) to the intact skin of male and female rabbits.

When undiluted Santicizer 278 (0.1 ml) was placed in the eyes of one female and two male albino rabbits, and subsequently rinsed after 24 hours, slight or no discomfort was observed immediately after the 24-hour exposure period, and barely perceptible erythema and slight discharge (but no oedema) were seen with an average score of 4 out of a possible 110 when examined at 1-hour post exposure. Eyes were apparently unaffected by treatment when examined 24, 48, 72, 120 and 168 hours after rinsing, giving an overall irritation score of 0 (average of scores assessed at 24, 48 and 72 hours after rinsing). The investigators classed the test material as a slight eye irritant in rabbits.

Additional acute skin irritation studies in humans, rabbits, rats, mice and guinea pigs, with various high molecular-weight phthalate esters (HMWPE), indicate that these compounds (with a carbon backbone of C7 or greater) are non-irritating to the skin. Similar results were observed in repeated dose studies with two Category members, with no irritation observed on rabbit skin following 15 exposures. Reversible irritation was observed on guinea pig skin.

Eye irritation studies conducted on rabbits also have shown the members of this category to be essentially non-irritating to the eyes, with only one compound showing slight eye irritation limited to the conjunctiva (OECD, 2004. Draft SIDS Initial Assessment Report on High Molecular Weight Phthalate Esters (HMWPE) category).


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Two studies on Santicizer 278 (which are only available in a brief summary report, reliability code 4) are considered adequate for concluding that the compound does not need to be classified for skin or eye irritation, under the EU CLP regulations.

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