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EC number: 285-332-6
CAS number: 85068-73-1
Skin irritation/corrosion: Data waiving (study scientifically not
necessary): According to column 2 of REACH Annex VII, the study does not
need to be conducted because an acute toxicity study by the dermal route
is available for the test substance and does not indicate skin
irritation up to 2 000 mg/kg body weight (limit dose test).
Serious eye damage/eye irritation: Key study. Method according to
OECD guideline 437, GLP study. The test item showed no effects on the
cornea of the bovine eye. The test item does not require classification
for eye irritation or serious eye damage.
Table 1.1. Illuminance Values (Unit: LUX)
(I) Measured values before exposure
(I) Measured values after exposure
Table 1.2. Opacity Values Negative Control
Opacity before exposure
Opacity after exposure
Mean Opacity Difference
Table 1.3. Opacity Values Test Item and Positive Control
Mean OpacityDifference corrected
Table 2.1. Optical density at 492 nm of Blank
cMEM without phenol red
Table 2.2. Optical density at 492 nm of Negative Control, Test Item and
1. Measurement – blank
2. Measurement – blank
3. Measurement – blank
Mean of each replicate
Mean of the 3 replicates
Corrected mean of the 3 replicates
Table 3. IVIS
Relative Standard Deviation IVIS
Positive ControlDMF undiluted
Note: the high relative standard deviation of the IVIS of the test item
is due to mathematical reasons, as the respective means are very small.
*IVIS = Mean Opacity value + (15 × Mean Permeability value)
An in vitro Bovine Corneal Opacity and Permeability (BCOP) study was
conducted in order to determine the potential severe eye damaging
effects of the test item according to the OECD guideline 437 under GLP
conditions. Three sets consisting of three corneas each were tested
using the closed chamber method: the first set was the negative control
and was treated with 750 μL Hank’s Balanced Salt Solution (HBSS); the
second set was the positive control and was treated with 750 μL of
dimethylformamide undiluted and the third set was treated with 750 μL of
test item without dilution. The corneas were exposed for 10 min at 32ºC.
After removal of the test item and 2 hours post-incubation, opacity of
the corneas and fluorescein permeability were measured. Negative control
showed No category (IVIS score 0.59) and resulted in opacity and
permeability values that are less than the established upper limits for
the background values. The positive control induced serious eye damage
on the cornea (IVIS score 86.97) and was within two standard deviations
of the current historical mean. The test item showed no effects on the
cornea of the bovine eye. The calculated mean IVIS was 0.07. According
to OECD Guideline 437, a substance with an IVIS ≤ 3 requires no
classification for eye irritation or serious eye damage.
Skin irritation/corrosion: Based on the available data, the
substance is not classified for skin irritation according to CLP
Regulation no. 1272/2008.
Serious eyes damage/eye irritation: Based on the available data,
the substance is not classified for eye irritation according to CLP
Regulation no. 1272/2008.
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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