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Description of key information

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
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)
Version / remarks:
July 2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
July 2012 (REG (EC) No. 440/2008 amended by REG (EC) No. 640/2012)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
validated in vitro test model for sequential testing strategy
Vehicle:
unchanged (no vehicle)
Details on test system:
see attached documents "S-600- Skin irritation Study Design.pdf"
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 11.8-13.2 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
- Concentration (if solution): neat

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL
- Concentration (if solution): 5% SDS in PBS
Duration of treatment / exposure:
15 ± 0.5 min
Duration of post-treatment incubation (if applicable):
42 h
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Value:
121
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

for detailed results see attached document "S-600 - Skin irritation Results.pdf"

Interpretation of results:
GHS criteria not met
Conclusions:
no classification according to REGULATION (EC) 1272/2008
Endpoint:
skin corrosion: 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
July 2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
May 2008 (REG (EC) No. 440/2008)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
validated in vitro test model for sequential testing strategy
Vehicle:
unchanged (no vehicle)
Details on test system:
see attached documents "S-600 - Skin corrosion Study Design.pdf"
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 39.3-45.5 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8N KOH
Duration of treatment / exposure:
3 min and 1 hour
Number of replicates:
4 (two for the 3-minute exposure and two for the 1-hour exposure)
Irritation / corrosion parameter:
% tissue viability
Remarks:
3-min exposure
Value:
90
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
1-h exposure
Value:
93
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

for detailed results see attached document "S-600 - Skin corrosion Results.pdf"

Interpretation of results:
GHS criteria not met
Conclusions:
no classification according to REGULATION (EC) 1272/2008
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
Version / remarks:
October 2017
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
human
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 60 mg
Duration of treatment / exposure:
6 hours ± 15 minutes
Duration of post- treatment incubation (in vitro):
18 hours ± 15 minutes
Number of animals or in vitro replicates:
2 tissues
Details on study design:
see attached documents "S-600 - Eye irritation (EpiOcular) Study Design.pdf"
Irritation parameter:
other: mean tissue viability (& of control)
Value:
104
Negative controls validity:
valid
Positive controls validity:
valid

for detailed results see attached document "S-600 - Eye irritation (EpiOcular) Results.pdf"

Interpretation of results:
GHS criteria not met
Conclusions:
Since the mean relative tissue viability for S-600 was above 60% S-600 is considered to be non-irritant, i.e. no classification according to REGULATION (EC) 1272/2008.
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

In the in vitro skin irritation/corrosion and eye irritation tests no adverse effects were obsserved. No classification according to REGULATION (EC) 1272/2008.