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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17-Jun-2014 to 28-Aug-2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EU method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guideline no. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)
EC Number:
277-749-7
EC Name:
Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)
Cas Number:
74181-84-3
Molecular formula:
C10H12CuN2O8.2K
IUPAC Name:
copper(2+) dipotassium 2-({2-[bis(carboxylatomethyl)amino]ethyl}(carboxylatomethyl)amino)acetate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): EDTA-CuK2
- Substance type:blue powder
- Physical state: solid
- Storage condition of test material: At room temperature in the dark
- Purity: 92.7%
- Lot/batch No.: FC-C 11531
- Expiration date of the lot/batch: 23 July 2016

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg, moistened with 5 µl water

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 10 µl Phosphate buffered saline

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 vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: percentage viability
Value:
75
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 15 minutes. (migrated information)
Irritation / corrosion parameter:
other: other: percentage viability
Value:
58
Remarks on result:
other:
Remarks:
Basis: other: percentage. Time point: 15 minutes. (migrated information)

Any other information on results incl. tables

Skin irritation is expressed as the remaining cell viability after exposure to the test substance.

The relative tissue viability for EDTA-CuK2 ranged from 6 to 111% in three independent experiments. Consequently, the result of these experiments is inconclusive.

 

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Conclusions:
The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles.
The relative tissue viability for EDTA-CuK2 ranged from 6 to 111% in three independent experiments. Consequently, the result of these experiments is inconclusive.

Based on the results of this test it should be labelled, according to Regulation (EC) No 1272/2008 (CLP), as: Causes skin irritation (H315).
Executive summary:

Skin irritation is expressed as the remaining cell viability after exposure to the test substance.

In the initial assay (first experiment) the relative tissue viability obtained after 15 minutes treatment with EDTA-CuK2 compared to the negative control tissues was 92, 94 and 40% for the individual tissues (mean 75%). Since the SD calculated from the individual % tissues viability of the three identically treated replicates was 31%, the acceptability criteria were not met and the experiment was repeated.

In the second experiment the relative tissue viability obtained after 15 minutes treatment with EDTA-CuK2 compared to the negative control tissues was 12, 15 and 13% for the individual tissues (mean 13%). This test was rejected due to a low response (OD570) of the negative control tissues and consequently an additional experiment was performed (protocol deviation 3).

In the third experiment the relative tissue viability obtained after 15 minutes treatment with EDTA-CuK2 compared to the negative control tissues was 55, 111 and 6% for the individual tissues (mean 58%). Since the SD calculated from the individual % tissues viability of the three identically treated replicates was 53%, the acceptability criteria were not met.

The relative tissue viability for EDTA-CuK2 ranged from 6 to 111% in three independent experiments. Consequently, the result of these experiments is inconclusive.

The positive control had a mean cell viability of 35, 21 and 40% after 15 minutes exposure in the three subsequently performed experiments, respectively. The absolute mean OD570(optical density at 570 nm) of the negative control tissues in the first and third experiment was within the laboratory historical control data range. The standard deviation of the percentage viability of three tissues treated identically with reference substances was less than 20%.