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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 Jan 2017 - 03 Feb 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2H-benzotriazol-2-yl)-4-tert-butylphenol
EC Number:
221-574-0
EC Name:
2-(2H-benzotriazol-2-yl)-4-tert-butylphenol
Cas Number:
3147-76-0
Molecular formula:
C16H17N3O
IUPAC Name:
2-(5-tert-Butyl-2-hydroxyphenyl)benzotriazole
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch: 02002IX3
- Purity: 99.9%
- Physical state determined at Envigo: White powder
- Physical state as per Certificate of Analysis: Crystalline, slightly yellow powder
- Physical state as provided by the sponsor: Slightly yellow powder
- Expiry Date: 25 Aug 2017
- Storage Conditions: Room temperature in the dark

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other:
Details on animal used as source of test system:
N/A
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model Kit
- EpiDermTM Tissues (0.63cm2) lot number: 23390
- Assay Medium lot number: 012617ZSA
- Delivery date: 31 Jan 2017

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
- Washing: Rinsing was achieved by filling and emptying each tissue under a constant soft stream of DPBS to gently remove any residual test item

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Linear OD range of spectrophotometer: 562 nm
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Identification: Sterile distilled water
- Batch: 3011859
- Expiry Date: 01 Oct 2017
- Storage Conditions: Room temperature in the dark

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Identification: 8.0N Potassium Hydroxide
- Batch: SLBM9898V
- Purity: 7.92N
- Expiry Date: 13 May 2017
- Storage Conditions: Room temperature in the dark
Duration of treatment / exposure:
3 and 60 min
Number of replicates:
2

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean Negative Control 3 min Exposure
Value:
100
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean Negative Control 60 min Exposure
Value:
100
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean Positive Control 3 min Exposure
Value:
3.6
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean Positive Control 60 min Exposure
Value:
4
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean Test Item 3 min Exposure
Value:
98.4
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean Test Item 60 min Exposure
Value:
104.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered to be non-corrosive to the skin.