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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2012-06-01 - 2012-09-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenyl diamidophosphate
EC Number:
231-218-6
EC Name:
Phenyl diamidophosphate
Cas Number:
7450-69-3
Molecular formula:
C6H9N2O2P
IUPAC Name:
[(diaminophosphoryl)oxy]benzene
Test material form:
solid: crystalline
Details on test material:
Name PPDA
Composition phosphoric acid phenylester diamide

CAS No. 7450-69-3
EINECS-No. 231-218-6
Molecular formula C6H9N2O2P
Molecular weight 172.1 g/mol
Purity 97.77% (HPLC)

Test animals

Species:
other: human skin model EpiDermTM

Test system

Type of coverage:
open
Vehicle:
other: DPBS-buffer
Amount / concentration applied:
Tissue Amount
1 24.8 mg
2 25.0 mg
3 23.6 mg
Duration of treatment / exposure:
60 min.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: % Formazan production
Value:
93.8
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 min. Max. score: 100.0. Reversibility: no data. (migrated information)

Any other information on results incl. tables

Designation

PPDA

Positive Control

% Formazan production (Tissue 1)

93.4%

5.7%

% Formazan production (Tissue 2)

93.4%

6.0%

% Formazan production (Tissue 3)

94.7%

5.7%

% Formazan production Mean

93.8%

5.8%

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered not irritant.
Executive summary:

One valid experiment was performed.

Three tissues of the human skin model EpiDermTMwere treated with PPDA for 60 minutes.

In average, 24.5 mg of the solid test item (wetted with 25 µL DPBS-buffer) were applied to each tissue and spread to match the tissue size (0.63 cm2; as indicated by supplier).

DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).

After the treatment with the test item, the relative absorbance values were reduced to 93.8 %. This value is well above the threshold for irritation potential (50%). Therefore, PPDA is considered as

not irritant in the Human Skin Model Test.