Iron, bis(glycinato-.kappa.N,.kappa.O)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

bis(λ⁴-iron(2+)) tetrakis(2-aminoacetate)

EC Number:

606-444-7

Cas Number:

20150-34-9

Molecular formula:

C4H8FeN2O4

IUPAC Name:

bis(λ⁴-iron(2+)) tetrakis(2-aminoacetate)

Test material form:

solid

In vitro test system

Test system:

human skin model

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

> 50

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Disks of EPISKIN (three units) were treated with test item and incubated for 15 minutes (± 0.5 min) at room temperature. Exposure of test material was terminated by rinsing with 1x PBS solution. Epidermis units were then incubated at 37 ± 1°C for 42 hours (± 1 h) in an incubator with 5 ± 1% CO2, ≥ 95 % humidified atmosphere. The viability of each disk was assessed by incubating the tissues for 3 hours (± 5 min) with MTT solution at 37 ± 1°C in 5 ± 1 % CO2 protected from light. The precipitated formazan was then extracted using acidified isopropanol and quantified spectrophotometrically.
The test item has an intrinsic colour (beige), therefore two additional test item treated tissues were used for the non-specific OD evaluation (NSCliving).
The test item is a MTT-reducer, therefore additional controls (test item treated killed tissues and negative control treated killed tissues) 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 (beige). 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 2.9 % (below 5 %), so the (NSCkilled) was not determined and used during the calculation of true MTT metabolic conversion.
SDS (5% aq.) and 1× PBS treated (three units / positive and negative control) epidermis were used as positive and negative controls respectively. For each treated tissue viability was expressed as a percentage relative to negative control.
The test chemical is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1), if the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50 % of the negative control.
In this in vitro skin irritation test using the EPISKIN model, the test item IRON GLYCINATE did not show significantly reduced cell viability in comparison to the negative control (mean value: 97 %). All obtained test item viability results were far above 50 % when compared to the viability values obtained from the negative control. Therefore the test item was considered to be non-irritant to skin.
Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.
The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin irritation potential under the utilised testing conditions. The test item IRON GLYCINATE is considered to be non-irritant to skin and is therefore not classified (UN GHS No Category).

Executive summary:

The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin irritation potential under the utilised testing conditions. The test item IRON GLYCINATE is considered to be non-irritant to skin and is therefore not classified (UN GHS No Category).