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Toxicological information

Skin irritation / corrosion

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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-methylbenzenesulfonic 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