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EC number: 216-245-3
CAS number: 1533-45-5
By applying the weight of evidence
approach, the test chemical can be considered to be not sensitizing to
skin. Comparing the annotations with criteria of CLP regulation, the
test chemical can be classified under the category "Not Classified".
The skin sensitization potential of
the test chemical was assessed based on the available results from the
various test chemicals.
Magnusson & Kligman guinea pig
maximization test (GPMT) was conducted on six Female Hartley strain
albino guinea pigs to assess the dermal sensitization potential of the
Induction treatment consisted of 3
intra-dermal injections and one topical induction. On day 0, a row of 3
injections of 0.1 ml test material emulsified mixture of Freund’s
complete adjuvant and saline (1:1) in olive oil was given on each side
of the 2x4 cm clipped neck . In order to enhance the sensitization,
sodium lauryl sulfate 10% in petrolatum was applied on induction area
for 24 h before the topical induction. On day 7, 0.5 g of 1.0% test
chemicals in petrolatum were occlusively applied for 48 h. The samples
were covered with lint pads which were lining with Blenderm tape.
The challenge treatment was given by
open topical application. On day 21, the flank regions of the animals
were clipped and shaved, and then 0.03 ml of test material in acetone
was applied to the skin for 72 hrs. Observations were made 48 hrs after
challenge. No positive reaction was elicited at the concentrations
Hence, the test chemical was
considered to be not sensitizing to guinea pig’s skin.
This result is supported by a human
repeated insult patch test conducted on 50 subjects to assess the
contact sensitization caused by the chemical under occlusive condition.
Induction was carried out at a dose of
5% in water on Mondays, Wednesdays and Fridays, total 10 applications
were made. After 24 hours patches were removed and skin sits were scored
for primary irritation. After a rest period of 10-14 days, a challenge
patch was applied (to the same site, an adjacent site or both). After 24
hours the patches were removed and the sites were examined for reactions
immediately and 24 and 48 hours later. Since there was no evidence of
any contact sensitization, the chemical was considered to be not
sensitizing on skin of human subjects.
The above results are further
supported by another Human repeated insult patch test conducted to
assess the skin sensitization potential of chemical.
When the chemical was applied dermally
on to the skin of each subject, no evidence of contact sensitization was
observed. Hence, the chemical was considered to be not sensitizing on
skin of human subjects in a human repeated insult patch test.
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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