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Administrative data

Description of key information

skin irritation/corrosion: negative (OECD 431, 439)

eye irritation/corrosion: negative (OECD 438)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-06-17 until 2015-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: per guideline study (GLP)
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
yes
Remarks:
the deviation from SOP didn't impact the result of the study.
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
other: SkinEthic Reconstituted Human Epidermis (RHE)
Cell type:
non-transformed keratinocytes
Details on test system:
Upon delivery, SkinEthic™ tissues (RHE/S/17) were treated according to the SOP.
At day 18, tissues were transferred to growth culture medium .Tissues were placed in
maintenance culture medium prior to application of test substances.
Details on study design:
The irritant potential of AFLAMMIT® PCO 962 was tested using the SkinEthic™ RHE model and expressed as a percent of the negative control tissue NC (exposed to Phosphate Buffer Saline, PBS).
Irritation / corrosion parameter:
% tissue viability
Value:
> 50
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid

 Treatment  Assay acceptance criterion  OD 570nm1  SD2
 PBS (NC)  0.8 <= OD <= 3  1.689  0.122
 SDS (PC)  -  0.020  0.001
 AFLAMMIT® PCO 962  -  1.790  0.041

 Treatment  Assay acceptance criterion  Viability %l  SD %2  I/NI3
 PBS (NC) SD <= 18%  100.0  7.22 NI
 SDS (PC)

 SD <= 18% and Viability < 40%

 1.2

 0.03

 I

 AFLAMMIT® PCO 962

  SD <= 18%

 106.0

 2.42

 NI

1: mean of 3 replicates

2: SD: Standard Deviation

3: I: Irritant; NI: Non Irritant

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The viability of the RHE in the presence of the test substance was above 50% at 42 minutes exposure and 42 hours recovery, following analysis by the MTT viability assay.
Therefore, the sample was classified as non-irritant.
Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2015-04-29 until 2015-04-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: per guideline study (GLP)
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
yes
Remarks:
Without impact on the result of the study.
GLP compliance:
yes (incl. QA statement)
Species:
other: SkinEthic™ tissues (RHE/S/17)
Details on test animals or test system and environmental conditions:
Upon delivery, SkinEthic™ tissues (RHE/S/17) were treated according to the SOP. Tissues were
transferred to 1 mL of maintenance culture media for a minimum of 3h pre-incubation step.
Amount / concentration applied:
Test materials (20 μl distilled water followed by 20 mg±3 mg) were applied to the RHE tissue (n=2) for 3 minutes and 1 hour at room temperature then rinsed.
Details on study design:
The corrosive potential of AFLAMMIT® PCO 962 was tested using the SkinEthic™ RHE model and expressed as a percent of the negative control tissue NC (exposed to ultrapure water).

Table 1: Comparative viability results of tested samples.

 Treatment  Assay acceptance criterion 3 minutes OD570nm1 SD2   1hour ODs1onm1  SD2
 Distilled water (NC)  0.8 <= OD <= 3.0  2.158  0.196  2.217  0.023
 Potassium hydroxide 8,0N (PCl  -  0.028  0.011  0.043  0.012
 AFLAMMIT® PCO 962  -  2.238  0.059  2.118  0.066

 Treatment  Assay acceptancecriterion  3 minutes              1hour  C/NC4
   Viability%1  SD%2  CV3  Viability%1  SD%2  CV3  
 Distilled water (NC)    100  9.07  9.07  100  1.05  1.05  NC
 Potassium hydroxide 8,0N (PC)    1.3  0.49  37.7  2.0 0.54  27.0   C
 AFLAMMIT® PCO 962    103.7  2.75  2.65  95.5  3.0  3.14  NC
Interpretation of results:
other: non-corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The viability of the RHE in the presence of the test substance was above 50% at 3 minutes and was above 15% after 1 hour exposure, following analysis by the MTT viability assay. Therefore, the sample was classified as non-corrosive.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-03-07 until 2016-03-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
To further establish the classification, histopathological observations were made
on two sections of each of the 3 corneas treated with test item (6 sections).
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
chicken
Strain:
other: Strain of chicken: ROSS 308; Source: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út. 129.
Vehicle:
unchanged (no vehicle)
Controls:
yes
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
Three eyes were treated with 30 mg of powdered test item.
Duration of treatment / exposure:
After 10 seconds, the surface of the eyes was
rinsed with physiological saline solution.
Duration of post- treatment incubation (in vitro):
The control and test eyes were evaluated pre-treatment and at approximately 30, 75,
120, 180 and 240 minutes after the post-treatment rinse.
Details on study design:
At the end of the evaluation procedures, the corneas were carefully removed from the eyes and
placed individually into labelled containers of preservative fluid (10% neutral buffered
formalin, Manufacturer: Reanal, Batch number: KTM14051, Expiry date: October
2017 for potential histopathology [9,10] and stored at room temperature.
Irritation parameter:
other: TEST ITEM
Run / experiment:
Overall ICE Class:1xI 2xII
Vehicle controls validity:
not valid
Negative controls validity:
valid
Remarks:
Overall ICE Class: 3xI
Positive controls validity:
valid
Remarks:
Overall ICE Class: 1xIII, 2xIV
Remarks on result:
other: Based on this in vitro eye irritation assay in the isolated chicken eyes test with AFLAMMIT PCO 962, the test item is not classified as a severe irritant and not classified as non-irritant.
Remarks:
It is concluded that further information is required for classification.I
Other effects / acceptance of results:
HISTOPATHOLOGY
Semi-quantitative microscopic evaluation was performed on the cornea in the ICET.
The classification of histopathology findings was performed based on two publications,
M.K. Prinsen et all. (Toxicology in Vitro 25 (2011), 1475-1479) and Elodie Cazelle et
all/ Toxicology in Vitro 28 (2014), 657-666.
The negative control 0.9 % Sodium chloride (Salsol solution) cornea showed no
abnormalities. Positive control, Imidazole was associated with moderate epithelial
erosion. No compromised Bowman’s or basement membrane as well as no endothelial
changes were recorded.
AFLAMMIT PCO 962 produced very slight vacuolation (15A, 15B) or very slight
erosion (16A) of the corneal epithelium. The 16B, 17A and 17B samples did not show
significant changes No stromal and endothelial changes were observed as well as no
effects on integrity of basement, Bowman’s and Descemet’s membranes.
Interpretation of results:
other: CLP criteria are not met.
Conclusions:
Based on this in vitro eye irritation assay in the isolated chicken eyes test with AFLAMMIT PCO 962, the test item is not classified as a severe irritant. It is concluded that further information is required for classification.
To further establish the classification, histopathological observations were made on two sections of each of the 3 corneas treated with test item (6 sections). Microscopic evaluation showed very slight vacuolation (15A and 15B) or very slight erosion (16A) of the corneal epithelium. The 16B, 17A, 17B samples did not show significant changes. No stromal or endothelial changes were observed as well as no effects on integrity of basement, Bowman’s and Descemet’s membranes.
Based on the data the CLP criteria for classification are not met.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

Based on the available data, the substance is not classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008.