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EC number: 220-688-8
CAS number: 2867-47-2
In a reliable study, the substance was found to be weak skin sensitizer.
The general behaviour and the body weight gain of the animals were not
influenced by the treatment. After the challenge cutaneous application
of the test substance, a very slight erythema (score 1) was observed on
the right flank of 16 out of 20 treated animals. As the cutaneous
reactions were very slight and the reactions observed at the 24 hrs
scoring period were reversible at the 48 hrs scoring period, the
cutaneous reactions were attributed to autoreactive effects. In both
readings, no oedema were observed. No cutaneous reactions likely to be
caused by the sensitization potential of this test substance were
Macroscopic examinations of the cutaneous reactions:
Scoring of the cutaneous parameters
LF = left flank (untreated); RF = right flank (treated); erythema score:
0 = no erythema, 1 = very slight erythema, 2 = well-defined erythema, 3
= moderate to severe erythema, 4 = severe erythema to slight eschar
There was only one study available for assessment. The sensitising
potential of the test substance was evaluated by a Guinea Pig
Maximazation Test (modified Magnusson and Kligman method) according to
OECD guideline No. 406 in compliance with GLP and was identified as the
key study (Atochem, 1991). The general behaviour and the body weight
gain of the animals were not influenced by the treatment. After the
challenge test, a very slight erythema (score 1) was observed on the
right flank of 16 out of 20 treated guinea pigs. As the cutaneous
reactions were very slight and the reactions observed at the 24 hours
scoring timepoint were reversible at the 48 hours scoring timepoint, the
cutaneous reactions were attributed to autoreactive effects. No
cutaneous reactions likely to be caused by a sensitisation potential of
the test substance were observed.
RECENT RE-EVALUATION OF THE STUDY INDICATED A SENSITISING POTENTIAL.
However, according to Annex I of the Directive 67/548/EEC and to
Annex VI of EU GHS, the substance is classified as skin sensitiser (R43;
There are no data available concerning respiratory sensitisation.
According to the well-conducted GLP guideline key study (OECD TG 406)
the test substance is not sensitising to the skin. Therefore, the
following classification of the test substance concerning sensitisation
GHS classification according to Annex I 1272/2008 CLP (EU GHS):
- Skin sensitisation: No classification.
However, the test substance is listed in Annex I of the Directive
67/548/EEC and in Annex VI 1272/2008 CLP (EU-GHS).
Accordingly, in spite of the contradictory database, the test substance
has to be classified as follows:
EU classification according to Annex I of the Directive 67/548/EEC:
- Skin sensitisation: May cause sensitisation by skin contact, R43
GHS classification according to Annex VI 1272/2008 CLP (UN GHS):
- Skin sensitisation: Skin sensitiser - Cat. 1
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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