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EC number: 252-046-8
CAS number: 34455-29-3
Skin sensitisation: equivalent to OECD 406. guinea pig. Not sensitising.
Reliability = 1
the end of the induction period, on day 10, after removal of the
dressing, signs of irritation in control and treated groups were
observed at the intradermal injection sites.
guinea-pigs (15 males and 15 females) were allocated to 2 groups: a
control group 1 (5 males and 5 females) and a treated group 2 (10 males
and 10 females). The sensitization potential of the test substance was
evaluated after a 10-day induction period during which time the animals
were treated with sterile isotonic saline solution (0.9% NaCl) (control
group) or the test substance (treated group). On day 1, in presence of
Freund's complete adjuvant, 0.1 ml of the test substance at a
concentration of 1% (w/w) in the vehicle was administered by intradermal
route. On day 8, 0.5 mL of the test substance in its original form was
applied by cutaneous route during 48 hours by means of an occlusive
dressing. After a period of 12 days without treatment, a challenge
cutaneous application of 0.5 mL of the vehicle (left flank) and 0.5 mL
of the test substance in its original form (right flank) were
administered to all animals. The test substance and the vehicle were
prepared on a dry gauze pad then were applied to the skin and held in
place for 24 hours by means of an occlusive dressing. Cutaneous
reactions on the challenge application sites were then evaluated 24 and
48 hours after removal of the dressing. After the final scoring period,
the animals were killed. Due to the absence of cutaneous reactions, no
skin samples were taken from the challenge application sites from all
the animals. The sensitivity of the guinea-pigs in experimental
conditions was checked in a recent study with a positive sensitizer,
dinitro-2,4-chlorobenzene. During induction period the test substance
was applied at 0.1 % (day 1) and 5% (day 8) concentrations. At cutaneous
challenge application, 1 % (w/w) was tested on the right flank. No
clinical signs and no deaths were noted during the study. After 24 and
48 hours following removal of the dressing of the cutaneous challenge
application of the test substance, no cutaneous reactions were recorded.
The guinea pigs which were used in a recent study showed a satisfactory
sensitisation response in 95% animals using a positive sensitizer. Under
the experimental conditions and according to the maximization method
established by Magnusson and Kligman, no cutaneous reactions
attributable to the sensitisation potential of the test substance in its
original form were observed in guinea pigs.
maximization test (equivalent to OECD 406) was conducted with guinea
pigs to determine the potential for the test substance to invoke dermal
skin sensitisation reactions. After 24 and 48 hours following removal of
the dressing of the cutaneous challenge application of the test
substance, no cutaneous reactions were observed. Based on the results of
this study, the test substance is not considered to be a contact skin
was no evidence of dermal sensitisation in guinea pigs. The substance
does not need to be classified for skin sensitisation according
to EU Classification, Labelling and Packaging of Substances and Mixtures
(CLP) Regulation (EC) No. 1272/2008.
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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