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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
/ Test conducted according to an acknowledged in vitro test procedure referred to as MatTek Corporation EpiDermTM Skin Model testing system, which in principle is similar to OECD TG 431 and 439.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Principles of method if other than guideline:
Test conducted according to an acknowledged in vitro test procedure referred to as MatTek Corporation EpiDermTM Skin Model testing system, which in principle is similar to OECD TG 431 and 439.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
EpiDerm Skin model closely parallels human skin. It consists of highly organized basal, spinous, granular and cornified layers analogous to those found in vivo.
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm Skin model, Ashland, USA

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The inserts were rinsed two times.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Incubation time: 3 h
- Spectrophotometer: Dynatech MR 4000 Automatic Microplate reader
- Wavelength: 570 nm

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
Control samples:
yes, concurrent negative control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 µg

NEGATIVE CONTROL
- Amount(s) applied: 100 µL
Duration of treatment / exposure:
1, 4.5 and 20 h

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
value of test item (100%) after 1 h
Value:
85
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
value of test item (100%) after 4.5 h
Value:
107
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
value of test item (100%) after 24 h
Value:
82
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Other effects / acceptance of results:
Based on the MatTek Corporation grouping, the substance is expected to be non-corrsoive and non-irritating to skin.

Any other information on results incl. tables

The time at which the percent viablility would be 50% (ET 50) was estimated by interpolation: >24 h.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified