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EC number: 823-920-1
CAS number: 5341-95-7
Skin sensitisation: non-sensitiser (in vivo, in silico).
The study used as source investigated skin sensitisation to guinea pig
after induction with 25 % test substance and challenge with 50 % test
substance. The study results of the source compound were considered
applicable to the target compound, and were used for classification and
labelling acc. to Regulation (EC) No 1272/2008. Justification and
applicability of the read-across approach (structural analogue) is
outlined in the read-across report in section 13
After the intradermal induction
intense erythema and swelling were observed at the injection sites of
all control group animals and all test group animals at which only
Freund's adjuvant/0.9% aqueous NaCI-solution was applied. At the
injection sites of a 5% test substance preparation in Freund's
adjuvant/0.9% aqueous NaCI-solution intense erythema and swelling were
seen in all test group animals. Injections of a 5% test substance
preparation in 0.9% aqueous NaCI-solution caused moderate and confluent
erythema and swelling in all test group animals. The control group
animals, injected with 0.9% aqueous NaCI-solution did not show any skin
reaction. A 50% formulation of 0.9% aqueous NaCI-solution with Freund's
adjuvant/0.9% aqueous NaCI-solution caused intense erythema and swelling
in all control group animals. The epicutaneous induction with a 50% test
substance preparation in doubly distilled water led to incrustation,
partially open (caused by the intradermal induction) and moderate and
confluent erythema with swelling in all test group animals.
The challenge with a 25% test
substance preparation in doubly distilled water did not cause any skin
reactions neither in control group 1 nor in the test group 24 and 48
hours after removal of the patches. Since no borderline results were
observed, a 2nd challenge was not performed. Control group 2, that had
been intended for a potential 2nd challenge was not applied and
therefore not reported.
No key study is available on skin sensitisation for the submission
substance. However, adequate and reliable data are reported here for a
structural analogue (source substance 2,3 -Butandiol). Please also refer
to the read-across justification document.
In the available key study, 2,3-Butandiol does not have a
sensitizing effect on the skin of the guinea pig in the Maximization
Test under the test conditions chosen.
In a supporting study performed with the submission substance,
skin sensitisation of (2R,3S)-butane-2,3-diol was predicted using the
OECD QSAR Toolbox 4.2 automated workflow (Read-across analysis, executed
via Automated "Skin sensitization"). No adaptations such as data pruning
were performed, and the automated prediction was accepted as valid by
Predicted endpoint: EC3, Skin sensitisation; No effect specified; No
species specified; No duration
specified; No guideline specified
Predicted value: Negative
Unit/scale: Skin sensitisation II (ECETOC)
Data gap filling method: Read-across analysis, executed via Automated
2,3-butanediol ((2R,3S)-rich) is not sensitising to skin (negative).
Therefore, (2R,3S)-butane-2,3-diol is not expected to cause allergic
skin reactions to humans. The prediction was considered reliable and
adequate to be used in human hazard assessment.
No classification and labelling for skin sensitisation is necessary
according to the Regulation (EC) No 1272/2008 based on the available
data. No data is available on respiratory sensitisation.
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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