2-phosphonobutane-1,2,4-tricarboxylic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD TG 431

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU Method B.40 (Skin Corrosion)

Principles of method if other than guideline:

The experiment was carried out on a reconstructed human epidermis EST-1000 (CeIiSystems, St. Katharinen, Germany)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-phosphonobutane-1,2,4-tricarboxylic acid

EC Number:

253-733-5

EC Name:

2-phosphonobutane-1,2,4-tricarboxylic acid

Cas Number:

37971-36-1

Molecular formula:

C7H11O9P

IUPAC Name:

2-phosphonobutane-1,2,4-tricarboxylic acid

Test material form:

solid

Details on test material:

- Purity: ca. 86 % (study report LNX31929, dated 2011-09-05, Spectral Services , D-50996 Köln, Germany)
- The substance is anhydrous.

Test animals

Species:

other: not applicable - in-vitro 3D skin corrosion test

Strain:

other: not applicable - in-vitro 3D skin corrosion test

Test system

Type of coverage:

other: not applicable - in-vitro 3D skin corrosion test

Preparation of test site:

other: not applicable - in-vitro 3D skin corrosion test

Vehicle:

other: not applicable - in-vitro 3D skin corrosion test

Controls:

other: not applicable - in-vitro 3D skin corrosion test

Duration of treatment / exposure:

After an exposure period of 3 or 60 minutes, followed by a post-treatment incubation period of about 3 hours, the cell viability was measured

Observation period:

not applicable - in-vitro 3D skin corrosion test

Number of animals:

not applicable - in-vitro 3D skin corrosion test

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: cell viability

Value:

109.19

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 3 minutes. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: non corrosive - scores in [%] viability. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: cell viability

Value:

19.64

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 60 minutes. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: non corrosive - scores in [%] viability. (migrated information)

Any other information on results incl. tables

Compound                                   [%] Cell viability 3 min       [%] Cell viability 60 min      Classification*

Bayhibit AM wasserfrei                            109.19                                      19.64               Non-corrosive                   

Negative control                                          100                                          100                 Negative control

*: Classification was done in accordance with the existing guideline and

internationally accepted protocols, i.e. evaluation of LD50 values after 3 min. and/or less than 15% viability after a 60 min. incubation period.

Applicant's summary and conclusion

Executive summary:

This study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed in 2011. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test item Bayhibit AM wasserfrei.

Corrosive skin effects of substances are defined as irreversible damage of skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to four hours. In vivo corrosive reactions are typified by ulcers, bleeding, and bloody scabs.

A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively. By this the study, was conducted in accordance with the OECD 431 guideline as well as with an EC guideline (amending Council Directive 67/548/EEC, B.40 Skin corrosion) using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion".

To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular intervals in the lab. This reliability check is always performed by two technicians, two laboratories in parallel using the same batches of the control test items.

The test item was applied at a 100% concentration, i.e. 25mg per insert.

(plus 50µl 0.9% NaCl to moisten and ensure good contact with the skin)

The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 109% and 20% (rounded), respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used.