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EC number: 293-014-3
CAS number: 91032-08-5
In the in vitro skin irritation test using the EpiDerm human epidermis
model 25 mg test item + 25 µL DPBS were applied topically for 60
minutes. After 42 h post-incubation cytotoxic effects were determined
via MTT reduction assay.
The test item showed no irritant effects. The mean relative tissue
viability (% negative control) was> 50% (137%) after 60 min treatment
and 42 h post incubation.
The tes item did not show corrosive effects in an in vitro ocular model
In an in vivo study in rabbits only temporary slight irritation was
found in the conjunctivae. only 1 of 3 animals showed finings of the
cornea and iris. All animals recovered completely within 4 to 9 days.
mean OD550of the replicates (blank-corrected)
total mean OD550of 3 replicate tissues (blank-corrected)
relative tissue viability [%]
SD tissue viability [%]***
CV [% viability]
mean relative tissue viability [%]
mean OD550of the negative control corresponds to 100%
absolute tissue viability.
** mean relative tissue viability of the three
positive control tissues is < 20%
deviation (SD) obtained from the three concurrently tested tissues is < 18%
This study is classified as acceptable:
Mean OD550 of the three negative control tissues is >=1 and <=2.5.
Mean relative tissue viability of the three positive control tissues is
Standard deviation (SD) of relative tissue viablity obtained from each
three concurrently tested tissues is < 18%.
This study satisfies the requirement for Test Guideline OECD 439 for in
vitro skin irritation.
The eye irritancy potential of Fatty acids, C16-18-, reaction products with diethanolamine was investigated in the bovine corneal opacity and permeability assay. The test item was diluted with physiological saline 0.9% NaCl to gain a 20% concentration. The following mean in vitro irritation score was calculated: 1.39Therefore the test item was non irritant to eyes. The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
Change of Opacity Value
Corrected Opacity Value
Corrected OD490 Value
Table: In Vitro Irritation Score
irritancy potential of Fatty acids, C16-18-, reaction products with
diethanolamine was investigated in the bovine corneal opacity and
of the test item: diluted with physiological saline
0.9% NaCl to gain a 20% concentration
vitro irritation score: 1.39
vitro irritation score obtained with the positive control fell within
the two standard deviations of the current historical mean and therefore
this assay is considered to be valid.
to the evaluation criteria the test item Fatty acids, C16-18-, reaction
products with diethanolamine is considered as non irritant to eyes.
Eye Irritation Scores
Animal No. 1
Average Score(24, 48 and 72 hours)
Single Data - Prolonged Observation Period
Animal No. 2
Animal No. 3
(24, 48 and 72 hours)
T = test item, C = control Clinical Signs of Toxicity
Time afterTest Item Application
Local Findings(apart from findings in Table 3)
discharge grade 2
discharge grade 3
discharge grade 1
Local Findings(apart from findings in Table 4)
Local Findings(apart from findings in Table 5)
nsf: no specific finding
Absolute Body Weights in kg:
Start of Study(weight in kg)
72 Hours Post-Application(weight in kg)
End of Observation Period(weight in kg)
Species/strain: New Zealand White Rabbits Crl: KBL (NZW)
Number of animals: 3
Amount of substance: 0.1 g per test site (neat)
First time of effects: animals no. 1 and 2:1 hour post-application redness grade 2 and chemosis grade 2 and discharge grade 2
animal no. 3: 1 hour post-application redness grade 1, chemosis grade 1 and discharge grade 1
Last time of effects: animal no. 1: 7 days post-applicationredness grade 1
animal no. 2: 8 days post-applicationredness grade 1
animal no. 3: 72 hours post-applicationredness grade 1
the observed effects: animal no. 1: the changes were fully reversible within 8 days post-application
animal no. 2: the changes were fully reversible within 9 days post-application
animal no. 3: the changes were fully reversible within 4 days post-application
Method: OECD 405
EC 440/2008, Method B.5 OPPTS 870.2400
Thecalculated mean scores did not exceed the limit values according to Directive 2001/59/EC, to Regulation (EC) 1272/2008 and to GHS (for details of the classification criteria see Evaluation of Results).
Mean Values of Eye Irritation Scores – (24, 48, 72 Hour Reading)
Under the conditions of the present study, a single ocular application of the test item Fatty acids, C16-18-, reaction products with diethanolamine to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within up to 9 days. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according toAnnex VI of Commission Directive 2001/59/EC, the test item Fatty acids, C16-18-, reaction products with diethanolaminehas no obligatory labelling requirement for eye irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item Fatty acids, C16-18-, reaction products with diethanolamine has no obligatory labelling requirement for eye irritation.
According to GHS (Globally Harmonized Classification System) the test item Fatty acids, C16-18-, reaction products with diethanolamine has no obligatory labelling requirement for eye irritation.
For details of the classification criteria see "Evaluation of Results."
This result was considered as indication of no irritant potential of the
test item on the skin.
This result was considered as indication of no significant irritant
potential of the test item on eyes and mucous membranes.
Skin: The test item showed no irritant effects in an in vitro human skin
model according to OECD guideline 439.
Eye: The test item did not show corrosive effects in an in vitro ocular
model (BCOP) and the mild conjunctival irritation in an in vivo eye
irritation study in rabbits were not sufficient for classsification.
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