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EC number: 266-587-2
CAS number: 67151-63-7
In a key, reliable guinea pig maximisation test according to OECD
Guideline 406 and EC method B.6, the test substance is observed to be
not sensitising to skin (Rossbacher, 1993).
After the intradermal induction well-defined erythema and slight edema
were observed at the injection sites of the control group animals and
test group animals at which only Freund's adjuvant/0.9% aqueous
NaCl-solution (1:1) was applied. Injection of the test substance in 0.9%
aqueous NaCl-solution caused well-defined erythema and very slight edema
in the animals of the test group. After application of the test
substance preparation in Freund's adjuvant/0.9% aqueous NaCl-solution
(1:1) well-defined erythema and slight edema could be observed in the
test group animals.
The control group animals which were treated with 0.9% aqueous
NaCl-solution did not show any skin reactions.
The percutaneous induction was only carried out in the test group
because with aqua bidest. a vehicle was used, that was not expected to
influence the result of the study.
Incrustation, partially open (caused by the intradermal induction) in
addition to well-defined erythema and slight edema could be observed.
Skin sensitisation - in vivo:
In a Klimisch 1-rated guinea-pig maximisation test (Rossbacher,
1993; according to OECD guideline 406), 10 females were first induced
intradermally with 0.1% test substance in 0.9% aqueous NaCl solution or
in Freund's adjuvant/0.9% aqueous NaCl solution (1:1) or 0.9% aqueous
NaCl solution. Seven days later the animals were topically induced with
an occlusive dressing containing 1% v/v test substance in distilled
water. The control animals were not treated since the distilled water
used as formulating agent was not expected to influence the result of
the study. On day 22, all animals were challenged by occluded
application of 0.5% v/v test substance in distilled water. Challenge
application of the 0.5% test substance in distilled water caused no skin
reaction in any of the test group animals 24 and 48 hours after
Challenge application of the 0.5% test substance in the negative
control group caused no skin reactions in any of the control animals.
Challenge application of the positive control substance in 1% ethanol
caused moderate to severe erythema and very slight edema in 2 out of 20
test group animals; 14 out of 20 animals of the test group showed
well-defined erythema, 11 of them additionally exhibited very slight
edema; very slight erythema in 4/20 test group animals.
Based on the results of the study under the test conditions, the test
substance does not have a sensitizing effect on the skin of the guinea
pig in the maximization test.
Skin sensitisation - in vitro:
An in vitro or in chemico skin sensitisation study does not need to be
conducted because adequate data from an in vivo skin sensitisation study
(initiated before October 11th, 2016) are available.
According to the criteria of the CLP Regulation, the test substance
should not be classified as sensitising to the skin. No data on
respiratory sensitisation is available.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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