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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
24 Sep - 29 Sep 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study of a draft guideline with acceptable restrictions (limited documentation)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD guideline for the testing of chemicals. Draft proposal for a new guideline. In vitro skin irritation: human skin model test, December, 2007
Deviations:
yes
Remarks:
- Interleukin-1 alpha was not determined
Principles of method if other than guideline:
The skin irritancy potenial of nickel hydrogencitrate was tested by using the human skin model EPISKIN and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt.
GLP compliance:
yes (incl. QA statement)
Remarks:
Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Strasse 7, 55116 Mainz, Germany

Test material

Constituent 1
Reference substance name:
Nickel(2+) hydrogen citrate
EC Number:
242-533-3
EC Name:
Nickel(2+) hydrogen citrate
Cas Number:
18721-51-2
Molecular formula:
C6H8O7.Ni
IUPAC Name:
hydrogen nickel(2+) citrate
Details on test material:
- Name of test material (as cited in study report): nickel hydrogencitrat
- Analytical purity: > 99%
- Batch No.: WRG 09012701037
- Expiration date of the batch: 26 Jan 2011
- Stability under test conditions: not indicated by the sponsor
- Storage condition of test material: At room temperature, dry

Test animals

Species:
other: in vitro test: human skin
Strain:
other: in vitro test: human skin

Test system

Type of coverage:
other: in vitro test: human skin model test
Preparation of test site:
other: in vitro test: human skin model test
Vehicle:
other: deionised water
Controls:
other: not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (weight): 25 mg of the neat test item were applied to each of triplicate tissues and wetted with 25 µL DPBS (Dulbecco's Phophate Buffered Saline) buffer.

VEHICLE
- Amount(s) applied (volume): 30 µL
Duration of treatment / exposure:
not applicable: see "any other information on materials and methods"
Observation period:
not applicable: see "any other information on materials and methods"
Number of animals:
not applicable: see "any other information on materials and methods"
Details on study design:
not applicable: see "any other information on materials and methods"

Results and discussion

In vivo

Irritant / corrosive response data:
Under the experimental conditions, the test item was not irritating to skin.

Any other information on results incl. tables

After treatment with the negative control the absorbance values were well within the required acceptability criterion thus showing the quality of the tissues. The positive control induced a decrease in the relative absorbance as compared to the negative control to 15.8% thus ensuring the validity of the test system. After tissue incubation with nickel hydrogencitrate, the relative absorbance values were increased to 120.7%. This value is well above the threshold for irritancy of 50%. Therefore, the test item is considered to have no skin irritation potential. Results see table 1.

Table 1:

Dose group

Treatment interval

Absorbance 570 nm, tissue 1*

Absorbance 570 nm, tissue 2*

Absorbance 570 nm, tissue 3*

Mean absorbance of 3 tissues

Rel. absorbance [% of negative control]**

Negative control

60 min

1.454

1.568

1.633

1.562

100.0

Positive control

60 min

0.253

0.249

0.240

0.247

15.8

Test item

60 min

1.912

1.876

1.868

1.885

120.7

*Mean of two replicate wells after blank correction

** relative absorbance [rounded values]: (100 x (absorbance test item)) / (absorbance negative control)

 

Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT reagent did not show blue color.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information