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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: EU method B.46 (In Vitro Skin Irritation) used for study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EU method B.46 (In Vitro Skin Irritation)/OECD Draft proposal for new guideline: In Vitro Skin Irritation
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-aminotoluene-3-sulphonic acid
EC Number:
201-831-3
EC Name:
4-aminotoluene-3-sulphonic acid
Cas Number:
88-44-8
Molecular formula:
C7H9NO3S
IUPAC Name:
2-amino-5-methylbenzene-1-sulfonic acid
Constituent 2
Reference substance name:
4B-Acid
IUPAC Name:
4B-Acid
Details on test material:
Purity: 98,9%

Test animals

Species:
human
Details on test animals or test system and environmental conditions:
EPISKIN standard model (three-dimensionel human epidermis model)

Test system

Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
water
Controls:
not required
Amount / concentration applied:
10 mg in 5 µl water
Duration of treatment / exposure:
15 min.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Mean absorbtion %
Value:
103
Remarks on result:
other:
Remarks:
Basis: mean of optical density at 570 nm. Remarks: Value is relative to negative control test. (migrated information)

In vivo

Irritant / corrosive response data:
A B C
Negativ control
OD570 measurement 1 0,898 0,871 0,893
OD570 measurement 2 0,858 0,866 0,863
4B-Acid
OD570 measurement 1 0,920 0,923 0,878
OD570 measurement 2 0,893 0,921 0,861
Positiv control
OD570 measurement 1 0,064 0,028 0,037
OD570 measurement 2 0,340 0,039 0,037

Any other information on results incl. tables

Mean absorbtion and standard deviation

A B C Mean SD
Negative control 0,878 0,869 0,878 0,875 0,005
4B-Acid 0,907 0,922 0,870 0,899 0,027
Positive control 0,049 0,034 0,370 0,040 0,008

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
If sample absorbtion is > 50% it is considered to be non-irritant
4B-acid is non-irritant