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EC number: 213-590-1
CAS number: 991-84-4
The test substance was not sensitising in a skin sensitisation study in
the guinea pig similar to the OECD guideline 406.
The skin sensitisation property of the test substance was determined
using a modified version of the Maximisation Test in the guinea pig. The
study was conducted similar to the OECD-Guideline 406. 20 guinea pigs
(Pirbright White Strain, 10 males and 10 females) were intradermally
treated with 4 injections of 0.1 ml freshly prepared adjuvant saline
mixture. At first induction, the test compound (10 %) was occlusively
applied on filter patches (2 x 4 cm) to the epidermis over the injection
sites for 24 hours. One week later, the test substance was occlusively
applied in the same way for 48 hours. The application sites were
pretreated the day before with 10 % sodium laurylsulphate (open
application). The challenge was performed 14 days later, when the test
compound (30 %) was applied epidermal on filter paper patches (2 x 2 cm)
to an untreated flank skin of the animals for 24 hours (occlusive
application). A control group was treated with adjuvant and the vehicle
during the induction period. During the challenge period thecontrol
animals were treated with the test substance to control the maximal
subirritant concentration of the test compound in adjuvant treated
animals. 24 hours after removal of the dressings the challenge reactions
were graded according to the Draize scale. The application sites were
chemically depilated before examination. 15 % of the animals in the test
substance group showed skin reactions 24 hours after removal of the
dressings. Concluding, the test substance did not reveal skin
sensitising properties in the guinea pig maximization test under the
test conditions chosen (Ciba-Geigy, 1982).
The results are supported by the findings from a human insult patch
study (Hill Top Research Institute Inc, No. K-141E, 1960; no guideline
followed). 59 subjects (12 men, 47 women) received 24 h patch exposures
to the test substance three times weekly for three weeks, followed by a
similar challenge exposure in the sixth week. The test substance did not
reveal skin sensitising properties in the human insult patch test under
the test conditions chosen.
Classification, Labeling, and Packaging Regulation (EC) No.
The available experimental test data is reliable and suitable for the
purpose of classification under Regulation (EC) No.1272/2008. Based on
the data, classification for skin sensitisation is not warranted.
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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