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EC number: 218-235-4
CAS number: 2090-05-3
Skin irritation: not irritating (OECD
Eye irritation: causes serious eye
irritation (OECD 405, GLP)
Table 1: Result
of the test item calcium dibenzoate
Negative Control (NK)
Positive Control (PC)
Test material (TM)
mean OD570of the duplicates (blank-corrected)
total mean OD570of 3 replicate tissues (blank-corrected)
relative tissue viability [%]
mean relative tissue viability [%]
SD tissue viability [%]***
CV [% viabilities]
mean OD570 nmof the negative control corresponds to 100%
absolute tissue viability.
relative tissue viability of the three positive control tissues is ≤
deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%
2: Historical data
Mean Relative Viability [%] PC
SD Viability [%]
Historical data were generatedfrom
2015 to 2016
According to the results of a bovine corneal opacity and permeability assay, since the IVIS was between 3 and 55, no prediction can be made regarding the test item Calcium dibenzoate.
Calcium dibenzoate did not show a skin
irritation potential in an in vitro test according to OECD Guideline 439
(In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method).
According to the criteria of Regulation (EC)
No 1272/2008 and its subsequent amendments, Calcium dibenzoate does not
have to be classified and has no obligatory labelling requirement for
Calcium dibenzoate induced serious but
reversible eye irritation in an in vivo study according OECD guideline
405 and is therefore classified as Eye irritant category 2 with
labelling H319: Causes serious eye irritation in accordance with
Regulation (EC) No 1272/2008 and its subsequent amendments.
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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