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EC number: 224-809-5
CAS number: 4500-29-2
In a GLP compliant OECD TG 431 study, the test item was investigated for skin corrosive properties using the three-dimensional human skin model EpiDermTM, comprising a reconstructed epidermis with a functional stratum corneum. Based on the results, the test itemis considered to be corrosive to skin. The eye irritancy potential of the undiluted test substance was investigated in the bovine corneal opacity and permeability assay according to OECD TG 437 in consideration of GLP criteria. With regard to the irritation scores obtained in this in vitro assay, the test item has to be considered severely irritating to eyes.
absolute OD550 -values
OD550(mean of 3 aliquots)
OD550(mean of 2 replicate tissues)
mean relative tissue viability [%]
mean inter tissue viability difference [%]***
OD550 >= 0.8
** mean relative tissue viability of
the 3 min. positive control <= 30%
*** inter tissue viability difference
*** inter tissue viability difference
The potential of the test item to induce skin corrosion was analysed by
using the three-dimensional human skin model EpiDermTM,
comprising a reconstructed epidermis with a functional stratum corneum.
The undiluted substance was applied topically to the EpiDermTM
tissue for 3 minutes and 60 minutes respectively, followed by immediate
determination of cytotoxic effects via the MTT reduction assay.
Corrosivity potential was predicted from the relative mean tissue
viabilities obtained after both treatment periods compared to the
corresponding negative control tissues concurrently treated with A. dest
The test item showed corrosive effects in that the mean relative tissue
viability (% negative control) was > 50% (95%) after3 minute
treatment and < 15% (13%) after 60 minute treatment. The controls
confirmed the validity of the study. The mean OD550 of the
two negative control tissues was > 0.8 for each exposure
period. The mean relative tissue viability (% negative control) of the
positive control was < 30% (12%) after 3 minute treatment. The
maximum inter tissue difference of replicate tissues of all dose groups
was < 30% (1.3% - 14.8%).
Based on the results of this study, the test item showed corrosive
effects. The test item therefore is classified as "corrosive".
The eye irritancy potential of the
undiluted test substance was investigated in the bovine corneal opacity
and permeability assay and the mean in vitro score was calculated to be
140.44. Based on the results of this study a mean in vitro score of
140.44 was obtained. The test substance therefore is classified as
severe eye irritant. The in vitro score obtained with the
positive control was within the current historical mean and therefore
this assay is considered to be valid.
The test item was tested for skin corrosion in the in vitro human skin
model test according OECD TG 431and in the in vitro membrane barrier
test according to OECD TG 435. Both test systems revealed that the test
item should be regarded as corrosive to skin. With respect to potential
eye irritation, the test item was evaluated in the bovine corneal
opacity and permeability assay (BCOP) following OECD test guideline 437.
Based on the scores revealed in this in vitro assay, it is concluded
that the test item is severely irritating to eyes. The above findings
from the in vitro test systems and the concluded severe irritative /
corrosive properties of the test item are most probably attributable to
the basicity of the submission substance.
In two guideline-compliant in vitro studies according to OECD TG 431 and
OECD TG 435, the test item showed corrosive effects. The test substance
is classified as “corrosive”, subcategory 1C according to GHS-CLP
(equivalent to EU Risk-Phrase R34 according to DSD), as the mean time to
activate the chemical detection system which was covered by a
bio-barrier membane was > 60 - 240 min (category 1).
With regard to eye irritation, a bovine corneal opacity and permeability
test for the identification ocular corrosives and severe irritants
revealed irritation scores triggering a classification as causing
serious damage to eyes (category 1) according to GHS-CLP (equivalent to
EU Risk-Phrase R41 according to DSD).
Although no conclusion on classification and labelling regarding
respiratory tract irritation can be derived due to lack of data,
classification of the submission substance as respiratory irritant
(category 3) according to GHS-CLP (equivalent to EU Risk Phrase R37)
seems to be appropriate when taking all data on the irritative
properties of the test item into account.
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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