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Administrative data

Description of key information

The substance was tested through in vitro validated studies in accordance with bottom-up approach. The substance was not irritant to Reconstructed human epidermis (RHE) and Reconstructed human corneal epithelium (RhCE).

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Reconstructed Human Epidermis (RHE), 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK).
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
About 50 mg of the test substance are weighed on a glass weighing boat. Then the sample is evenly poured on the tissue. The exact weight of the sample is not a critical factor, but it is necessary to cover all the surface of the tissue homogeneously.
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
After 24±2 hours of incubation, the tissues were transferred to new plates containing 0.9 mL of fresh medium in each well and incubated for an additional 18±2 hours (37 °C, 5% CO2).
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 Vitality tests
Value:
ca. 96.7
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The average OD for negative control (C-) was f 1.257. This value corresponds to 100% vitality of the tissues.
The vitality of tissues trated with positive control was 3.5%.
The vitality of tissues trated with test item was 96.7% with SD 3.8%.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is considered not irritant for human skin.
Executive summary:

The test substance was tested through a validated in vitro skin irritation study in accordance with  bottom-up approach. Under the test conditions, the test substance was not irritant for Reconstructed Human Epidermis (RHE) as % tissue viability was about 96.7. Overall, the test substance is not considered as a skin irritant.

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:
The test started on November 17. 2021 (9.30 a.m.), and ended on November 18, 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 492:2019
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. QA statement)
Species:
human
Details on test animals or tissues and environmental conditions:
Reconstructed human corneal epithelium (RhCE) tissues
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
yes, concurrent positive control
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
6 hours
Duration of post- treatment incubation (in vitro):
18 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
percent tissue viability 
Run / experiment:
two replicates
Value:
ca. 77.2
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Mean OD for the negative control tissues (C-) was 1.319. This value corresponds to 100% vitality of the tissues.
The vitality of positive control was 20.8%.
The vitality of treated samples was 77.2% with SD% of 0.2.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on above results, the test substance may be considered as: not irritant for the eyes.
The present test does not allow to discern between irritant category 1 or 2.
Executive summary:

The test substance was tested through a validated in vitro eye irritation study in accordance with  bottom-up approach. Under the test conditions, the test substance was not irritant for Reconstructed human corneal epithelium (RhCE) as % tissue viability was about 77.2. Overall, the test substance is not considered as an eye irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the data available, the substance should not be classified for skin and eye irritation under CLP Regulation.