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EC number: 200-073-0
CAS number: 50-97-5
Table 3. Results and Discussion
No. of animals
Dermal Responses(Timing post- exposure)
Three Minutes Exposure
One Hour Exposure
Absent to very slight
Four Hours Exposure
No abnormal physical signs were observed among all three animals.
Two animals gained weight and one study animal lost weight by study termination.
Primary Irritation Index (PII) =0.4Response Category:Practically Non-irritating (Negligible)
DOT:Not corrosive, NoEPA:NotGHS:Not packing group assignment Classified Classified
OECD 404 (2016) -the irritant or corrosive effects of the test article
was assessed following application to the clipped skin of white New
Zealand rabbit. The test article (0.5 g) was applied dermally to Site 1
for exposure period of 3 minutes under occlusive patch. Since the
reaction of the initial animal did not produce a corrosive or severely
irritating effect, two additional animals (one female and one male) were
added to the study. All three animals were dosed at Site 2 for an
exposure period of one hour and Site 3 for an exposure period of four
hours. Erythema and edema were scored at 1, 24, 48 and 72 hours after
patch removal for the one and four-hour exposures. Animals were observed
for mortality, toxicological and pharmacological effects at least once
daily. Body weights were recorded pre-test and at termination.
No abnormal physical or systemic signs were observed among all three
animals. Two animals gained weight and one study animal lost weight by
study termination. No mortality reported.
Very slight erythema and oedema was noted within 24 hours post exposure
and it was fully reversible. The Primary Irritation Index (PII) of
theist item was reported as 0.4.
Under the condition of the study, it was concluded that test item was
not corrosive and does not cause irritation to the rabbits’ skin.
Therefore, the test item does not meet the criteria for classification
according to the Globally Harmonized Classification System and to the
Regulation (EC) No. 1272/2008, relating to the Classification, Labelling
and Packaging of Substances and Mixture.
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