Copper, .beta.-resorcylate salicylate lead complexes

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 May 2010 to 25 June 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Compliant to GLP and testing guideline (the minor deviation observed, a 4-minute exposure instead of a 3-minute exposure, did not impact the reliability of the study as the test material was not corrosive at any of the exposure times); adequate coherence between data, comments and conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 431 Guideline "In vitro skin corrosion: Human skin model test"

Deviations:

yes

Remarks:

A '-minute exposure was conducted instead of a 3 minute-exposure

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Copper Lead Resorcylate Salicylate Complex

EC Number:

614-455-3

Cas Number:

68411-07-4

Molecular formula:

C7H5O4-, C7H5O3- Cu , Pb

IUPAC Name:

Copper Lead Resorcylate Salicylate Complex

Details on test material:

- Name of test material (as cited in study report): lead-copper-resorcylate-salicylate
- Substance type: multicontituent
- Physical state: pale green powder
- Composition of test material, percentage of components: 11.9% of copper, 35.7% of lead, 14.1% of resorcylate and 35.7% of salicylate
- Lot/batch No.: 09/201
- Expiration date of the lot/batch: 04 November 2011
- Storage condition of test material: at room temperature in the dark

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg of the solid test material was applied topically to the corresponding tissues ensuring uniform coverage of the tissues.

Duration of treatment / exposure:

4, 60 and 240 minutes

Number of animals:

Not applicable

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: cell viability in percentage (based on optical density (absorbance) at 540 nm)

Value:

95

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 4 minutes. Reversibility: other: not applicable. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: cell viability in percentage (based on optical density (absorbance) at 540 nm)

Value:

86.3

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 60 minutes. Reversibility: other: not applicable. (migrated information)

Results 3

Irritation / corrosion parameter:

other: other: cell viability in percentage (based on optical density (absorbance) at 540 nm)

Value:

69.8

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 240 minutes. Reversibility: other: not applicable. (migrated information)

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Conclusions:

The test material was considered to be Non-Corrosive to the skin and assigned the EU risk phrase of No label, UN packing group Non-Corrosive and a CLP risk phrase regulation of Non-corrosive.

Executive summary:

Introduction:

The purpose of this test is to evaluate the corrosivity potential of the test material using the EPISKIN^TMin vitro Reconstituted Human Epidermis (RHE) Model after treatment periods of 4, 60 and 240 minutes. This method was designed to meet the requirements of the following guideline:

- OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004)

The EPISKIN^TMmodel is able to distinguish between corrosive and non-corrosive chemicals for all of the chemical types studied. As stated in regulation 1272/2008/EEC a validated in vitro test such as in vitro skin corrosion test in the EPISKIN^TMmodel can be used for classification and labelling. The EPISKIN^TMmodel is also able to distinguish between known R35 (UN packing group I) and R34 (UN packing group II & III) chemicals.

Methods:

Duplicate tissues were treated with the test material for exposure periods of 4, 60 and 240 minutes. At the end of the exposure period the test material was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. 

At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre‑labelled 96‑well plate. The optical density was measured at 540 nm.

Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).

Results:

The relative mean viability of the test material treated tissues was:

4 minutes exposure: 95.0%
60 minutes exposure: 86.3%
240 minutes exposure: 69.8%

Quality criteria:

The quality criteria required for acceptance of results in the test were satisfied.

Discussion:

The protocol instructed a 3 minute exposure to be conducted. However, in error a 4 minute exposure was conducted. As the test material was non-corrosive after prolonged 60 and 240 minute exposures and clearly non-corrosive after a 4 minutes exposure the purpose of this study was considered to have been achieved and the integrity of the study was considered acceptable.

Conclusion:

The test material was considered to be Non-Corrosive to the skin and assigned the EU risk phrase of No label, UN packing group Non-Corrosive and a CLP risk phrase regulation of Non-corrosive.