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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD TG 431 and EC B40
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate
EC Number:
700-422-1
Cas Number:
61320-65-8
Molecular formula:
C8 H8 N2 O2 S
IUPAC Name:
methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate
Details on test material:
content 99.1 %
batch no. BOS 2589

Test animals

Species:
other: in vitro
Strain:
other: in vitro
Details on test animals or test system and environmental conditions:
in vitro test

Test system

Controls:
other: in vitro test: negative control 0.9 % NaCl
Amount / concentration applied:
50 µl
Duration of treatment / exposure:
3 min and 60 min (3 inserts per period)
Observation period:
after the exposure period of 3 min or 60 minthe inserts were washed carefully in PBS and MTT reduction assay was performed
Number of animals:
in vitro test
Details on study design:
The experiment was carried out in accordance with tje OECD 431 guideline as well as with an EC guideline (amending Council Directtive 67/548/EEC B 46 skin corrosion) using commercially available reconstructed human epidermis(RHS) model EST-1000. Undiluted diazokomponente Rot B was applied topically to the RHS model: 25 mg of the test item per insert ( plus 30µl 0.9 % NaCl to moisten and ensure good contact wtih the skin; RT: three inserts per period of incubation).Aafter the exposure period of 3 min or 60 min the inserts were washed carefully in PBS. Afterwards the MTT reduction assay was performed to measure the cell viability.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: absorption: at 570 nm
Value:
2.32
Remarks on result:
other:
Remarks:
Basis: other: negative control. Time point: 3 min. Max. score: 2.32. Reversibility: no data. Remarks: Optical Density (OD):2.32 = 100 % viability. (migrated information)
Irritation / corrosion parameter:
other: other: absorption at 570 nm
Value:
2.26
Remarks on result:
other:
Remarks:
Basis: other: test item. Time point: 3 min. Max. score: 2.32. Reversibility: no data. Remarks: OD mean 2.32 = 100 % viability; OD mean 2.26 = 95.38 % viability. (migrated information)
Irritation / corrosion parameter:
other: other: absorption at 570 nm
Value:
2.32
Remarks on result:
other:
Remarks:
Basis: other: negative control. Time point: 60 min . Max. score: 2.32. Reversibility: no data. Remarks: Optical Density (OD):2.32 = 100 % viability. (migrated information)
Irritation / corrosion parameter:
other: other: absorption at 570 nm
Value:
2.16
Remarks on result:
other:
Remarks:
Basis: other: test item. Time point: 60 min. Max. score: 2.32. Reversibility: no data. Remarks: OD mean 2.32 = 100 % viability; OD mean 2.16 = 97.88 % viability. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Executive summary:

An in-vitro study for predicting non-specific, corrosive potential of Diazokomponente Rot B by using reconstructed human skin (RHS) EST-1000 in accordance with OECD TG 431 and with an EC guideline (amending Concil Direcrive 67/548/EEC B 40 Skin corrosion). Diazokomponente Rot B was tested undissolved (25 mg per insert, plus 50 µl 0.9 % NaCl to moisten and to ensure good contact with the skin) and an incubation time of 3 min or of 60 min was used to determine time related toxic effects. After incubation the MTT reduction assay was performed to measure the cell viability which was 95 % and 98 % , respectively. Thus, the results show that no corrosive property of the test inem was determined by the assay used (Bayer AG 2011).