Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 July 2010 - 02 August 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Guideline no. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (adopted 22 July 2010).
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 10 µl
- Concentration (if solution): 5% (aq) Sodium dodecyl sulphate


Duration of treatment / exposure:
Exposure: 15 minutes
Post incubation period: 42 hours
Details on study design:
TEST SITE
- Area of exposure: human epidermis model
- % coverage: 0.38 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 15 minutes

POST INCUBATION PERIOD
- 42 hours

SCORING SYSTEM:
- After a 42-hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.

Results and discussion

In vivo

Results
Irritation parameter:
other: Percentage viability
Basis:
other: Percentage of control
Time point:
other: 15 minutes
Score:
80

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
It is concluded that this test is valid and that Complexation products of sodium tartrate with iron trichloride is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report
Executive summary:

In vitroskin irritation test with Complexation products of sodium tartrate with iron trichloride using a human skin model.

 

This report describes the ability of Complexation products of sodium tartrate with iron trichloride to induce skin irritation on a human three dimensional epidermal model (EPISKIN Standard model (EPISKIN-SMTM)). The possible skin irritation potential of Complexation products of sodium tartrate with iron trichloride was tested through topical application for 15 minutes.

 

The study procedures described in this report were based on the most recent OECD and EC guidelines.

 

Batch 29/30-06-2010 of Complexation products of sodium tartrate with iron trichloride was a dark green liquid with a purity of approximately 35% complexation product in water. Complexation products of sodium tartrate with iron trichloride was applied undiluted (10 µl) directly on top of the skin tissue for 15 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

 

Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Complexation products of sodium tartrate with iron trichloride compared to the negative control tissues was 80%. Since the mean relative tissue viability for Complexation products of sodium tartrate with iron trichloride was above 50% after 15 minutes treatment Complexation products of sodium tartrate with iron trichloride is considered to be non-irritant.

 

The positive control had a mean cell viability of 6% after 15 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.

 

Finally, it is concluded that this test is valid and that Complexation products of sodium tartrate with iron trichloride is non-irritant in thein vitroskin irritation test under the experimental conditions described in this report.