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EC number: 701-008-3
CAS number: -
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).
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
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)
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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