Speiss, lead, nickel-contg.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 8, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to GLP and actual testing guidelines.

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 Test guideline No 431: in vitro skin corrosion: human skin model test, adopted 13 April 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Speiss, lead, nickel-contg.

EC Number:

308-765-5

EC Name:

Speiss, lead, nickel-contg.

Cas Number:

98246-91-4

IUPAC Name:

Speiss, lead, nickel-contg.

Constituent 2

Reference substance name:

Nickel speiss

IUPAC Name:

Nickel speiss

Details on test material:

- Name of test material (as cited in study report): nickel speiss
- Physical state:solid
- Date of manufacture:2010-01-07
- Lot/batch No.:52690100309M000000
- Storage condition of test material:room temperature
- pH value: 6.99 (10% suspension in water)
- Density: 7.75

Test animals

Species:

other: in vitro

Test system

Type of coverage:

other: topical application on 3D cultures

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

122.3 mg (±1.2 mg)

Duration of treatment / exposure:

3 min and 1h

Details on study design:

- EpiDerm model

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: in vitro % tissue viability compared to the negative control (100%)

Value:

ca. 83.6

Remarks on result:

other:

Remarks:

Time point: 3 min. Max. score: 94.3. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: vitro % tissue viability compared to the negative control (100%)

Value:

ca. 86

Remarks on result:

other:

Remarks:

Time point: 1h. Max. score: 86.2. (migrated information)

In vivo

Irritant / corrosive response data:

- 83.6% viability after 3 min exposure
- 86.0% viability after 1h exposure

Any other information on results incl. tables

The following prediction model was applied

Mean tissue viability [% of negative control]	In vitro irritation scale
3 min.: < 50	Corrosive
3 min.: ≥ 50 / 1h: < 15	Corrosive
3 min.: ≥ 50 / 1h: ≥ 15	Non-corrosive

Viability of the exposed epidermis models as determined by Standard MTT Assay

	Quality control Skin barrier 1% Triton X-100 reduced solution Mean viability [% of NC*]	Negative control (Ultra Pure Water)   Mean viability [% of NC]	Positive control 8N KOH     Mean viability [% of NC]	Test substance Nickel Speiss     Mean viability [% of NC]
3 min		100.0 (± 6.0)	6.2 (± 0.1)	83.6 (± 10.7)
1h		100.0 (± 17.9)	5.1 (± 0.4)	86.0 (± 0.2)
2h	84.0 (± 2.0)	100.0 (± 0.2)
Result	Validity criteria OK	Validity criteria OK	Validity criteria OK	Non corrosive

* Negative Control

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Remarks:

Criteria used for interpretation of results: other: OECD test guideline 431

Conclusions:

It is concluded that Nickel speiss has to be predicted as non corrosive to skin when the prediction model of in vitro skin corrosion testing using in vitro reconstructed human epidermis models is applied according to the international OECD Test Guideline 431

Executive summary:

In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Model Test
A key in vitro skin corrosion study with a three-dimensional reconstructed human epidermis (RHE; EpiDerm^TMmodel) was conducted with Nickel speiss according to the GLP guidelines and the OECD 431 test guideline. Two RHE cultures of EpiDerm^TMwere topically exposed to 122.3 mg (±1.2 mg) Nickel speiss. Corrosive effects were determined after 3 min and 1 h exposure by determining cell viability using the standard MTT Assay. The viability of the negative control was set to 100%.

The acceptance criteria for the study with negative and positive controls were met and the study was considered reliable, adequate and relevant.

Application of Nickel speiss on top of the stratum corneum of two EpiDerm^TMcultures resulted in a mean cell viability of 83.6 % (±10.7 %) after 3 min exposure period and 86.0 % (±0.2 %) after 1 h exposure period. Additionally, it was found that Nickel speiss itself did not reduce MTT. It is concluded that Nickel speiss has to be predicted as non corrosive to skin when the prediction model of in vitro skin corrosion testing using in vitro reconstructed human epidermis models is applied according to the international OECD Test Guideline 431.