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EC number: 201-645-2 | CAS number: 85-98-3
The testing strategy for skin irritation was followed:no literature data and studiesassessment of physicochemical properties and pH measurement - approx. 7 (by contact with universal indicator pH strip moistened with water)In vitro skin corrosion test - negative resultIn vitro skin irritation test - negative resultIn vivo skin irritation/corrosion test - negative resultThe testing strategy for eye irritation/corrosion was followed:no literature data and studiesassessment of results of skin irritation/corrosion testsassessment of physicochemical propertiesIn vitro BCOP test - negative resultIn vivo eye irritation/corrosion test - negative result
The test substance, Centralit, was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test.
Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.
At first the test substance was applied on the skin of one rabbit (test animal No. 13). Rabbit No. 13 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance.
No evidence of a corrosive effect or symptoms of irritation were observed on the skin after application.
In confirmatory test, two others rabbits (rabbit No. 14 and No. 15) were used with 4-hour exposition period.
No symptoms of irritation on the skin were observed. No other signs of intoxication were observed.
No skin irritation was caused by 4-hour exposure to Centralit.
The test substance, Centralit, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test was performed initially using one animal. Because a corrosive or severe irritating effects were not observed in initial test, the response was confirmed using two additional animals.
The following changes were observed on eye at 1 hour after application: conjunctivae – diffuse, crimson colour, individual vessels not easily discernible in all rabbits and some swelling above normal in one rabbit (No. 16). At 24, 48 and 72 hours after application no irritating effects of eye was observed in all animals.
No clinical signs of systemic intoxication were detected.
Evaluation of results after single application demonstrated that the test substance, Centralit, is not irritating for eye of rabbit.
Justification for selection of skin irritation / corrosion endpoint: In vivo study Justification for selection of eye irritation endpoint: In vivo study
Based on the available data, the substance is not classified.
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