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EC number: 224-809-5
CAS number: 4500-29-2
The sensitization potential of the test item was investigated using the
maximization method according to Magnusson and Kligman (OECD TG 406) in
guinea pigs in accordance with the principles of GLP. 10 male test and 5
male control animals were used for the study. For selection of the test
concentrations to be used in the main study, irritation screens
following intradermal and topical administration of test substance were
performed. After intradermal injection of 0.1, 0.5, 1 and 5% (v/v) the
degree of erythema was assessed. Due to severe skin reactions the
animals treated with 1% and 5% were killed for humane reasons following
the 24 hour observation. 0.1% causing mild to moderate irritation was
selected for the intradermal induction treatment for the main study.
Screening for topical induction concentrations were performed using 75%,
50%, 25%, 5%, 1%, 0.5% and 0.1% (v/v) test substance in water. Due to
severe dermal reactions the animals treated with 25% and higher were
killed for humane reasons immediately after the 1 hour observation. 5%
test item in water which was tolerated systemically and produced only
mild to moderate dermal irritation was selected for the topical
induction stage of the main study and 5% as well as 1% for the dermal
challenge tretament. Patches for both topical induction and challenge
were kept in contact with the skin under occlusive conditions for 48 and
24 hours respectively. Following the topical induction, discrete or
patchy to moderate erythema was elicited by the test material in all
animals from the test and control group. However, no skin reactions were
noted at the challenge sites (5% and 1%) of the test or control group
animals at the 24 or 48 hour observations. Based on the results, the
test item produced a 0% (0/10) sensitisation rate and is considered to
be a non-sensitiser to guinea pigs under the conditions of the test.
The sensitization potential of the submission substance was investigated
in an guideline conform maximization test in male guinea pigs according
to magnusson and Kligman. 10 test and 5 control animals were used. Based
on the results of sighting tests, 0.1% (v/v) for the intradermal
induction, 5% (v/v) for the topical sensitization as well as 5% and 1%
(v/v) for the dermal challenge phase were selected as concentrations of
the test material. As vehicle distilled water was used. Under the
conditions of this test, the submission substance produced a 0% (0/10)
sensitization rate and was classified as a non-sensitizer to guinea pigs.
With regard to respiratory tract sensitisation the submission substance
is not considered to exert sensitizing effects on the respiratory tract.
Due to its severe irritating / corrosive properties and a related
self-warning effect any inhaltion exposure will be minimized.
Additionally, from a guideline conform maximization test, no indications
concerning sensitizing properties exist.
A guideline conform maximization study (OECD TG 406) with the submission
substance showed no evidence for sensitising properties.
Thus, it can reasonably be deduced that the submission substance does
also not cause respiratory tract sensitization and thus does not have to
be classified according to the criteria laid down in the EU Dangerous
Substances Directive (67/548/EEC) and in the EU Classification Labelling
and Packaging Regulation (1272/2008/EC).
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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