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EC number: 701-354-5
CAS number: -
There is an In-vitro skin irritation: human
skin model test according to OECD guideline 439 using EpiSkin tissues. There
is an old non-standard CAM test for eye irritation and modern GLP
studies the Bovine Corneal Opacity (BCOP) test and a rabbit eye
OD 570 nmWell 1
OD 570 nmWell 2
Mean OD of 2 Wells
of 2 Wells blank
of 3 tissues
Rel. Viability [%] Tissue1, 2 + 3*
of viability values
Mean Rel. Viability
* Relative viability [rounded values]: [100 x (absorbance test item/
postive control/ negative control)]/ mean absorbance negative control
** Mean relative viability [rounded values]: [100 x (mean absorbance
test item/ postive control/ negative control)]/ mean absorbance negative
This in vitro study was performed to assess the irritation potential of
Sodium cocopropylenediamine propionate, CAS 97659-50-2 by means of the
Human Skin Model Test according to OECD TG 439.
The test item did not reduce MTT (pre-test for direct MTT reduction),
and it did not dye water, when mixed with it (pre-test for colour
interference). Also its intrinsic colour was not intensive.
Consequently, additional tests with freeze-killed or viable tissues were
Three tissues of the human skin model EpiSkin™ were treated with the
test item, the negative control (PBS) or the positive control (5% sodium
lauryl sulfate) for 15 minutes.
After treatment with the negative control the absorbance values were
well within the required acceptability criterion of mean OD 0.6 till ≤
1.5 thus showing the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the
relative absorbance as compared to the negative control thus ensuring
the validity of the test system.
After treatment with the test item the mean relative absorbance value
was 100.6%. This value is above the threshold for irritancy of ≤ 50%.
Therefore, the test item is not considered to possess an irritant
In conclusion, it can be stated that in this study and under the
experimental conditions reported, Sodium cocopropylenediamine
propionate, CAS 97659-50-2 is not irritant to skin according to UN GHS
and EU CLP regulation.
egg no 22: light injection; light TCL score
egg no 23: light injection score 1
egg no 24: light injection; light TCL score
mean score: 2.3
Twenty-two materials were assessed in the
CAM test, an in vitro prescreen
for predicting in vivo ocular irritancy. The test also included negative
(sterile water) and positive (glacial acetic acid) controls. Day 10
fertilised chicken eggs were used to obtain chorioallantoic membranes
Only undamaged, well formed CAMs were used
in the test. The test material was tested in triplicate, as supplied,
and applied directly to the CAM surface: solvent and positive control
materials, and the test material, were applied as 200 µl aliquots. The
test material was left in contact with the membrane for 20 sec, after
which time it was washed away by irrigation with warm sterile water.
Observations of reactions in the CAM were made during a five minute
period immediately after irrigation. The intensity of vascular
injection, the extent of haemorrhage and the occurrence of coagulation
of cytosolic proteins were assessed. Based on the results of this study,
Ampholak YCE would be a moderate irritant in vivo. The sensitivity of
the test system to a known irritant was shown by the response to the
positive control material, glacial acetic acid.
Individual and Mean Corneal Opacity and Permeability
In Vitro Irritancy Score
Post-Incubation - Pre‑Treatment
OD= Optical density * = Mean of the
post-incubation -pre‑treatment values ¨= Mean
permeability ·= Mean corrected value
Corneal Epithelium Condition Post Treatment and Post Incubation
The purpose of this test was to identify test items
that can induce serious eye damage and to identify test items not
requiring classification for eye irritation or serious eye damage. The
Bovine Corneal Opacity and Permeability (BCOP) test method is an
organotypic model that provides short‑term maintenance of normal
physiological and biochemical function of the bovine cornea in vitro. In
this test method, damage by the test item is assessed by quantitative
measurements of changes in corneal opacity and permeability.
The test method can correctly identify test items
(both chemicals and mixtures) inducing serious eye damage as well as
those not requiring classification for eye irritation or serious eye
damage, as defined by the United Nations (UN) Globally Harmonized System
of Classification and Labelling of Items (GHS) and EU Classification,
Labelling and Packaging (CLP) of chemicals (Regulation (EC) No
1272/2008), and it was therefore endorsed as scientifically valid for
both purposes. Test items inducing serious eye damage are classified as
UN GHS and EU CLP Category 1. Items not classified for eye irritation or
serious eye damage are defined as those that do not meet the
requirements for classification as UN GHS/EU CLP Category 1 or 2 (2A or
2B), i.e. they are referred to as UN GHS/EU CLP No Category.
The test item was applied at a concentration of 10%
v/v in 0.9% w/v sodium chloride for 10 minutes followed by an incubation
period of 120 minutes. Negative and positive control items were tested
concurrently. The two endpoints, decreased light transmission through
the cornea (opacity) and increased passage of sodium fluorescein dye
through the cornea (permeability) were combined in an empirically
derived formula to generate an In Vitro Irritancy Score
The test item is classified according to the
prediction model as follows:
EU CLP(Regulation (EC) No 1272/2008)
Not classified for irritation
>3; ≤ 55
No prediction can be made
Category 1H318: Causes serious eye damage
The In Vitro irritancy scores are summarized
prediction of eye irritation can be made.
Individual and Mean Scores for Cornea, Iris and Conjunctivae
The study was performed to assess the irritancy potential of the test
item to the eye of the New Zealand White rabbit.
A single application of the test item to the non-irrigated eye of two
rabbits produced scattered or diffuse corneal opacity, iridial
inflammation and moderate to severe conjunctival irritation.
Both eyes appeared normal at the 14–Day observation.
The test item meets the criteria for classification as ‘Irritating to
eyes (Category 2)’ according to Regulation (EC) No. 1272/2008, relating
to the Classification, Labelling and Packaging of Substances and
The test item meets the criteria for classification as ‘Irritating to
eyes (Category 2/2A)’ according to the Globally Harmonized System of
Classification and Labelling of Chemicals.
derivs., trisodium salt CAS No 2136366-30-6, is sold as a ca. 30%
solution in water. Inhalation is not an expected route
of exposure so no inhalation tests are available.
In-vitro skin irritation: human skin model
test according to OECD guideline 439 using EpiSkin tissues was assessed. The
viability of the tissues was 100.6%, as this was greater than 50% the
test substance was not classified as a skin irritant. . Therefore
it is not classified as a skin irritant.
The Bovine Corneal Opacity Permeability
Assay (BCOP) was carried out following OECD guideline 437. The
irritancy score was 6.5 which is higher than the cut off for none
classification of 3.0. It was also less than the limit
for classification as Category 1 for eye damage which is >55. It
was there concluded that no prediction can be made. A
rabbit study was required to establish if Category 2 for eye irritation
the rabbit eye irritation study OECD 405. The test item produced a
maximum group mean score of27.0and
was classified as amoderateirritant
a 1 to 8 scale) to the rabbit eye according to a modified Kay and
Calandra classification system.
test item meets the criteria for classification as ‘Irritating to eyes
(Category 2)’ according to Regulation (EC) No. 1272/2008, relating to
the Classification, Labelling and Packaging of Substances and Mixtures. The
mean score 24/48/72 hours was 1 for corneal opacity, 1.0 for iridial
inflammation, 2.0 for conjunctival redness and 1.7 for chemosis, the
corneal opacity and iridial inflammation which recovered within the 14
days of the study resulted in this classification.
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