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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 July 2017 - 27 July 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
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphonic acid, magnesium salt (2:1)
Cas Number:
13598-61-3
Molecular formula:
Mg·2H3O3P
IUPAC Name:
Phosphonic acid, magnesium salt (2:1)
impurity 1
Chemical structure
Reference substance name:
Phosphonic acid
EC Number:
237-066-7
EC Name:
Phosphonic acid
Cas Number:
13598-36-2
Molecular formula:
H3O3P
IUPAC Name:
Phosphorous acid
impurity 2
Reference substance name:
Minor impurities not relevant for classification
IUPAC Name:
Minor impurities not relevant for classification
Test material form:
solid: particulate/powder
Details on test material:
- Density: 2.01 g/cm3- Moisture content: 2.9% (w/w)

In vitro test system

Test system:
human skin model
Remarks:
SkinEthic RHE model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Vehicle:
unchanged (no vehicle)
Remarks:
Epidermal surface was previously moistened with distilled water.
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE- Model used: Reconstructed Human epidermis (SkinEthic RHE® model, Episkin SA, RHE/S/17) - Tissue batch number(s): 17-RHE-079- Production date: not reported- Shipping date: not reported- Delivery date: 25 July 2017- Date of initiation of testing: 25 July 2017TEMPERATURE USED FOR TEST SYSTEM- Temperature used during treatment / exposure: not reported- Temperature of post-treatment incubation (if applicable): 37°CREMOVAL OF TEST MATERIAL AND CONTROLS-Volume and number of washing steps: 42 minutes after the test item application, the human epidermis were washed with 25 x 1 mL of DPBS (Dutscher - Batch No. 7530417).- Observable damage in the tissue due to washing: none- Modifications to validated SOP: noneMTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE- MTT concentration: 1.0 mg/mL- Incubation time: 3 hours- Spectrophotometer: ELx800 absorbance microplate reader- Wavelength: 570 nm- Filter: not reported- Filter bandwidth: not reported- Linear OD range of spectrophotometer: not reportedNUMBER OF REPLICATE TISSUES: 3CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCEThere is no direct interaction between the test item and MTTPREDICTION MODEL / DECISION CRITERIA (choose relevant statement)- The test item is considered as non-irritant to skin in accordance with UN GHS No Category: if the mean percent viability after 42 minutes exposure and 42 hours of post-treatment incubation is > 50%.- The test item is identified as requiring classification and labelling according to UN GHS (Category 2): if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non corrosive”.- The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1): if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16 mg/0.5 cm2
Duration of treatment / exposure:
42 min
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
98.6
Negative controls validity:
valid
Remarks:
mean tissue viability 100%
Positive controls validity:
valid
Remarks:
mean tissue viability 2.2% for 5% sodium dodecyl sulfate

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item magnesium dihydrogen phosphite has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.No hazard statement or signal word is required.