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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study available as unpublished report, no restrictions, contributing to a weight of evidence assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Principles of method if other than guideline:
EpiDerm corrosivity-test in vitro.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Ethylenediamine p-toluenesulphonate
EC Number:
230-728-6
EC Name:
Ethylenediamine p-toluenesulphonate
Cas Number:
7294-10-2
IUPAC Name:
ethane-1,2-diamine 4-methylbenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Ethylendiamin-Monosylat

Test animals

Species:
other: EpiDerm™ tissues (reconstructed three dimensional human epidermis model)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: positive and negative controls
Duration of treatment / exposure:
3 min and 1 h
Details on study design:
Two EpiDerm tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability.
The tissue viability was calculated by reading Optical Densities (OD) using a spectrophotometer at 570 nm wavelength.

EVALUATION OF RESULTS
A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: viability [% of NC]
Value:
91
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: corrosion, exposure: 3 min, mean OD570: 2.212. (migrated information)
Irritation / corrosion parameter:
other: other: viability [% of NC]
Value:
27
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: corrosion, exposure: 1 hour, mean OD570: 0.680. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
other: non-corrosive
Conclusions:
Under the conditions of the test the substance is considered to be not corrosive to the skin.
Executive summary:

The corrosive potential was determined in an EpiDerm™ Corrosivity-Test in vitro. Two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue viability was determined after exposure to the test substance. This was decreased to 91% after 3 minutes exposure and to 27% after 1 hour exposure. Based on this the test substance was considered to be non-corrosive.