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EC number: 202-597-5
CAS number: 97-63-2
Reevaluated according CLP criteria
Comparison with CLP criteria:
Remark: Exposure time was higher than 4 hours, observation time
only 72 hours.
Two scores were > 2.3 but observation time too short. The highest
mean erythema score is 2 for 3/6 animals. The highest edema score is 3
for 1/6 animals. The observation time was too short to demonstrate
Shaved and scarifized skin (not used for evaluation):
acc. DSD criteria
2 h Exposure, shaved skin, occlusive
primary dermal irritation study according to “Federal Hazardous
Substances Labelling Act Regulations, Section 191.11, Federal Register:
29, 13009 (1964), 6 young adult New Zealand White rabbits were dermally
exposed to 0.5 mL of EMA for 24 hours to 2.5x 2.5 cm body surface area
of the shaved/scarified skin. Animals then were observed for 3 days.
Irritation was scored by the Draize method. This scoring system is
similar to OECD guideline 404.
animals with the shaved intact skin were evaluated for C&L purposes.
24 h after
application 2 animals showed very slight (score1) and 4 animals well
defined (score 2) signs of erythema and 3 animals very slight (score 1),
2 animals slight (score 2) and 1 animal moderate (score 3) edema. 72 h
after application 2 animals showed no erythema (score 0), 2 animals very
slight (score 1) and 2 animals well defined erythema (score 2). No edema
were observed after 72 h in 2 animals, slight edema (score 2) in 2
animals and moderate (score 3) in 2 animals. Acc. CLP criteria in 2/6
animals mean edema scores (24 +72h) were > 2.3. As observation time was
only 72 h and reversibility could not be observed EMA is considerd as
irriating to skin.
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