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Description of key information

This studies relevant for these endpoints were performed according to GLP and the methods applied were fully compliant with OECD TG 437 and 439. The test material was not irritating to skin and not irritating to eye in vitro.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-11-23 to 2015-12-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to
Guideline:
other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
GLP compliance:
yes (incl. certificate)
Test system:
human skin model
Justification for test system used:
standard model
Vehicle:
water
Details on test system:
CELL CULTURE
- Supplier: SkinEthic Laboratories (Lyon, France).
- Source: adult human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
Control samples:
yes, concurrent negative control
yes, concurrent vehicle
Amount/concentration applied:
16 mg test material per tissue spread with 10 µL deionized water to matching tissue size
Duration of treatment / exposure:
42 min
Duration of post-treatment incubation (if applicable):
n.a.
Number of replicates:
3
Irritation / corrosion parameter:
other:
Value:
1.947
Remarks on result:
other:
Remarks:
Time point: 42 min. Max. score: 2.054. Remarks: mean of 3 values (2,054, 1.893, 1.895). (migrated information)
Irritation / corrosion parameter:
other:
Value:
93.92
Remarks on result:
other:
Remarks:
Time point: 42 min. (migrated information)
Other effects / acceptance of results:
Optical density (as a marker of cell viability) of test item is comparable to value of the negative control. The test is to be considered as valid because:
a) optical density of negative control (mean value: 2.074+/-2.9%) > 0.8 and < 3.0 and standarad deviation <= 18%. Historical mean= 1.423
b) relative cell viability of the positive control (mean value: 1.10; standard deviation 2.22%) < 3.42% and standard deviation <= 18%
c) standard deviation of test item < 18%

 Group Time / [min]  Mean OD  Mean Relative viability / [%]
 Negative Control 42   2.074 100 
 Positive Control 42

0.023

1.10 

 Test Material

42

1.947

93.92 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was negative in this assay.

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:
2015-11-20 to 2015-11-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
750 µL (i.e. 150mg/750µL) of test item, negative or positive control
Duration of treatment / exposure:
240 minutes
Number of animals or in vitro replicates:
in vitro: triplicate design
Irritation parameter:
in vitro irritation score
Run / experiment:
run 1
Value:
113.9
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Run / experiment:
run 1
Value:
62.2
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein leakage
Run / experiment:
run 1
Value:
3.45
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Opacity
Permeability
IVIS
per cornea
per group
(mean value)
SD
Negative Control
0.9 % NaCl Solution
-0.062
-0.001
-0.082
0.8
0.9
1.816
-0.001 1.801
0.706
-0.001 0.696
Positive Control
20 % Imidazole  solution
70.793
2.142
102.928
106.6
4.1
71.315
2.303
105.860
79.270
2.119
111.060
Test material
Art. 132039
66.507
3.447
118.217
113.9
16.4
72.337
3.699
127.827
47.660
3.206
95.780


Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the given experimental conditions the test material the test material has ocular corrosive potential.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. The test material was corrosive in this in vitro assay.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No effects have been observed in in vitro assays as outlined above.