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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
not specified
Test system:
other: human reconstituted epidermis model
Source species:
human
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
Amount/concentration applied:
25 µL, i.e. 10 mg
Duration of treatment / exposure:
1 hour
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 98
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Conclusions:
BASF SE in vitro skin irritation (OECD 439) Turnkey Testing Strategy :

Under the conditions of the study, with 1 hour exposure and 42 hours postincubation, it was concluded that the test substance does not show a skin irritation potential.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N-ethylpyridazin-4-amine
EC Number:
846-827-8
Cas Number:
1521274-68-9
Molecular formula:
C6H9N3
IUPAC Name:
N-ethylpyridazin-4-amine
Details on test material:
- State of aggregation: solid/brown

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: human reconstituted epidermis
Vehicle:
unchanged (no vehicle)
Details on test system:
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE

- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: 2

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-corrosive to skin if [complete, e.g. 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%.]
Control samples:
yes, concurrent negative control
Amount/concentration applied:
single topical exposure of 25 µL, i.e. 10 mg
Duration of treatment / exposure:
3 min. and 1 hour
Number of replicates:
2

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min. exposure
Value:
ca. 105
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour exposure
Value:
ca. 70
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, with 3 min. and 1 hour exposure, it was concluded that the test substance does not show a skin corrosion potential.