Registration Dossier
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EC number: 695-757-2 | CAS number: 897381-19-0
Endpoint summary
Administrative data
Description of key information
The skin and eye studies performed according to OECD 404 and 405 guideline to assess the skin and eye irritation potential of the substance. The study showed that the substance is not irritant to skin, but Precursor PD 206 is irritant to eyes according to EU CLP .
Key value for chemical safety assessment
Additional information
Skin Irritation:
The purpose of the study was to determine the potential irritant and/or corrosive effects of the test article on the skin of rabbits. Precursor PD 206 was administered dermally to three New Zealand White rabbits at 0.5 mL per site. The exposure periods were 3 and 60 minutes and/or 4 hours, respectively.
The most severe dermal responses observed were very slight erythema of one animal on Day 2, resolving by Day 3 after 60 mins exposure. PD 206 was found to be non-irritating according to the EEC Irritation Rating and the GHS Classification. The Primary Irritation Index was 0.0.
Eye Irritation:
The purpose of the study was to determine the potential irritant and/or corrosive effects of the test article on the eyes of rabbits.
The test article Precursor PD 206, was initially instilled into the anesthetized right eye of one male New Zealand White rabbit at a dose of 0.1 mL. Upon instillation of the test article, the eyelids were held closed app.1 second to limit loss of material. The anesthetized left eye was untreated. Following the twenty-four hour scores of the first animal, two additional animals were dosed. Both eyes of all three animals were examined and scored for ocular irritation according to the method of Draize (4) prior to dosing. 1 hour after dosing (+/-15min), at 24, 48, 72 hours (+/-1 hour) through Day 7 (0680 and 0681) and Day 8 (0679) post dose.
No corneal, iris or conjunctival irritation was observed in the untreated eyes of the rabbits at any time point. The ocular irritation detected in the treated eyes were fully reversible in Day 8. Precursor PD 206 was not an irritant to eyes, according to DSD criteria, whilst the subtance was found to fall into the EU CLP Category 2 - Reversible Eye Effects.Justification for classification or non-classification
Based on the skin and eye irritation study results, Precursor PD 206 should not classified as skin irritant according to EU CLP and DSD, but should be classified as Eye Irritant Category 2 according to EU CLP .
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