Registration Dossier

Administrative data

Description of key information

Substance is classified as corrosive, class 1A

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
yes
Test system:
human skin model
Irritation / corrosion parameter:
% tissue viability
Value:
<= 35
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
According to the first experiment results the test item was corrosive after 4 hours (±10 min) exposition, so the additional experiment was necessary with more exposure times [testing at 3 minutes and 1 hour (±5 min)]. In this case, the 4 hours procedure was repeated during the additional experiment, but with an additional 3 minutes and 1 hour exposure period.
Disks of EPISKIN (two units) were treated with test item and incubated for 4 hours (±10 min) at room temperature on April 03, 2019 (first experiment).
Furthermore, disks of EPISKIN (two units / exposure time) were treated with test item and incubated for 4 hours (±10 min), 1 hour (±5 min) and 3 min at room temperature on June 05, 2019 (additional experiment).
Exposure of test material was terminated by rinsing with PBS 1x solution. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37±1°C in 5±1% CO2 in a ≥ 95% humidified atmosphere and protected from light. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically.
NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively.
The test item has an intrinsic colour (brown), therefore two additional test item treated tissues were used for the non-specific OD evaluation NSCliving in both experiments.
The test item is a MTT-reducer, therefore additional controls [(test item treated killed tissues and negative control treated killed tissues) / exposure time in both experiment] were used to detect and correct for test substance interference with the viability measurement.
The test item is a MTT-reducer and has an intrinsic colour (brown). To avoid a possible double correction [TODTT (MTT and NSCliving)] for colour interference, a third control for non-specific colour in killed tissues (NSCkilled) was performed.Two killed test item treated tissues were used to avoid a possible double correction for colour interference. However, the NSCliving was below 5% in all cases, so the NSCkilled was not determined and used during the calculation of true MTT metabolic conversion.
For each treated tissue viability was expressed as a % relative to negative control. The test item is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure is above or equal 35 % of the negative control.
The test item showed significantly reduced cell viability (below 35 %) in comparison to the negative control after 4 hours of exposure in first and additional experiments. In the first experiment (April 04, 2019) the average test item treated tissue relative viability was 4% at 4 hours of exposure and in the additional experiment (June 06, 2019) it was 0% at 4 hours of exposure.
In the additional experiment (April 04, 2019) the test item showed significantly reduced cell viability (below 35 %) in comparison to the negative control after 1 hour and 3 minutes of exposure. The average test item treated tissue relative viability was 7% at 1 hour of exposure and 21% at 3 minutes of exposure.
Positive and negative controls showed the expected cell viability values within acceptable limits in the first and additional experiment.
All assay acceptance criteria were met, the experiment was considered to be valid.
In conclusion, in this in vitro skin corrosion test in EPISKIN model with VANADIUM DIASCORBATE the results indicate that the test item is corrosive to skin after 4 hours, 1 hour and 3 minutes of exposure time. According to the UN GHS classification systems, VANADIUM DIASCORBATE has been categorized as “Corrosive: Optional Sub- category 1A”.
Executive summary:

The test substance is corrosive 1A

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

no data

Justification for classification or non-classification