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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:
02 November 2017 - 22 December 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
July 29, 2016
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Batch: 1013Q17761
Purity: 100%
Appearance: White powder
Expiry Date: 25 June 2017
Storage Conditions: At room temperature

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
As per OECD Test Guideline.
Vehicle:
water
Control samples:
yes, concurrent vehicle
yes, concurrent positive control
Amount/concentration applied:
25 μL of deionised water and 25 ± 2mg (39.7 mg/cm2 according to guideline) of the test item.
Each 50 μL were applied to each set of duplicate tissues.
Duration of treatment / exposure:
• Test Item: 3 ± 0.5 minutes, 60 ± 5 minutes
• Negative Control: 3 ± 0.5 minutes, 60 ± 5 minutes
• Positive Control: 3 ± 0.5 minutes, 60 ± 5 minutes
Duration of post-treatment incubation (if applicable):
3 hour post-treatment incubation period
Number of replicates:
Duplicate.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minute
Value:
103.1
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 minutes
Value:
89.2
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time (range: 1.535 to 1.700)
- Acceptance criteria met for positive control: the mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control (2.4%)
- Acceptance criteria met for variability between replicate measurements: the Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (range: 0.4% to 5.4%)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is considered to be a non-corrosive to skin.
Executive summary:

In an in vitro skin corrosion study human skin tissue (eipdermis keratinocytes) was exposed to the substance for 3-minutes and 1-hour. There was 103.1% and 89.2% tissue viability following the 3-minutes and 1-hour exposure points, respectively. Resultantly, the substance is considered to be a non-corrosive to skin.