Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium

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: GLP-studyof skin corrosion potential according to OECD guideline 431

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD guideline no. 431 In vitro Skin Corrosion: Human Skin Model Test

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

The pure active substance was used.
Purity: 99%
Batch number: Catena-08-183
Production date: 16.05.2008
Expiry date: 05.2009
Storage: Closed vessel at room temperature in the dark

Test animals

Species:

other: human skin model EpiDerm (TM)

Details on test animals or test system and environmental conditions:

EpiDerm (TM) Epi-200 tissue and MTT assays diluent were procured from MatTek Corporation, Ashland, US.
Delivery date: 10.06.08
Batch-number: 10529

Test system

Type of coverage:

not specified

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

25 mg (to each tissue), moistened with 25µl after application to reconstructed skin

Duration of treatment / exposure:

3 minutes and 60 minutes

Observation period:

not applicable

Number of animals:

not applicable

Details on study design:

Two wells each were used for negative control, positive control and test substance.

Results and discussion

In vivo

Irritant / corrosive response data:

not applicable

Any other information on results incl. tables

The test substance is considered to be corrosive to skin:

i) if the viability after 3 minutes exposure is less than 50%, or

ii) if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.

The test substance is considered to be non-corrosive to skin:

i) if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.

Exposure duration	test substance viability	positive control viability
3 minutes	103.8%	34.4%
60 minutes	74.3%	22.8%

Therefore, the positive control has to be considered as corrosive (viability after 3 min < 50%), but the test substance is to be considered non-corrosive to skin.

The negative and the positive control performed in the range of the historical control data.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test subtstance is to be considered as not corrosive, but as a skin irritant.

Executive summary:

As there is no indication that the substance produces a false negative result in the used in vitro test, the negative result of the test is to be considered valid. Therefore, the test subtstance is to be considered as not corrosive. However, the substance has severe eye irritation potential (see Chapter 7.3.2) and should be considered as a skin irritant.