Registration Dossier

Administrative data

Description of key information

In rabbit tests for skin and eye irritation, involving 24-hour application of Santicizer 261, 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:
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 and eye irritation studies have been carried out with Santicizer 261 (Younger Laboratories, 1976c,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.

 

When undiluted Santicizer 261 (0.5 mL) was applied to the intact and abraded skin of six New Zealand albino rabbits for 24 hours, erythema was seen on the abraded and intact skin sites in all six rabbits, 24 hours after removal of the test material (with a score of 1 according to the method of FHSA). No erythema was noted when assessed at 4, 48, 72 and 168 hours after removal of the test material, and no oedema was reported during the 7-day observation period. The investigators classed the test material as non-irritating when applied to the intact and abraded skin of rabbits.

 

When undiluted Santicizer 261 (0.1 ml) was placed in the eyes of six New Zealand albino rabbits, and removed after 24 hours (presumably by rinsing), slight discomfort was observed immediately after the 24-hour exposure period, and slight erythema and slight to moderate discharge were seen at 10 minutes and 1 hour after rinsing (with an average irritation score at 1 hour after rinsing of 6 out of a possible 110 according to the method of FHSA). Eyes were apparently unaffected by treatment when examined 24, 48, 72, 120 and 168 hours after the end of the exposure period, 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 non-irritating to the eyes of 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).

 

Human and animal respiratory tract irritation data are not available for Santicizer 261a 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).

Justification for classification or non-classification

Two studies on Santicizer 261 (which are only available in a brief summary report, reliability code 4) are considered adequate for concluding that the substance does not need to be classified for skin or eye irritation, under the EU CLP regulations.