Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-4-methoxypyridine-2-carboxylic acid
Cas Number:
210300-09-7
Molecular formula:
C7H7NO4
IUPAC Name:
3-hydroxy-4-methoxypyridine-2-carboxylic acid
Specific details on test material used for the study:
Substance name: X696476
Lot #: ENBK-172341-024 (TSN402909)
Purity: 100%

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: epithelial
Cell source:
other: human skin
Vehicle:
other: Calcium & Magnesium Free Dulbecco’s Phosphate Buffered Saline (CMF-DPBS)
Remarks:
Since the test substance was a solid, 25 μL of sterile Calcium & Magnesium Free Dulbecco’s Phosphate Buffered Saline (CMF-DPBS) were applied to the tissues prior to addition of approximately 25 mg of the test substance
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
The test substance, was administered to the test system without dilution (neat).
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
42-hour post-exposure incubation
Number of replicates:
03

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
97.74
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cell viability: 97.74% (Non irritant)
Executive summary:

The MatTek Corporation’s EpiDermTM reconstituted human epidermis model was used to assess the potential skin irritation of the test substance. The skin irritation potential was evaluated based upon measuring the relative cell viability in treated tissues at 42-hour post-exposure incubation after a 60-minute exposure to the test substance, according to the OECD TG 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method” (TG 439).


The test substance, was administered to the test system without dilution (neat). The test substance was not determined to directly reduce the MTT and was not considered to have probable photometric MTT interference. The results of the positive and negative control met the criteria for a valid assay.


Under the conditions specified in this study, the test substance, resulted in a cell viability of 97.74% and thus was predicted to be a non-irritant to the skin. Accordingly, the test substance, would not require classification and labelling for skin irritation according to UN GHS and EU classification systems.