Registration Dossier
Registration Dossier
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EC number: 201-831-3 | CAS number: 88-44-8
Skin irritation / corrosion
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:
- 2 010
- 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
- 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
- Reference substance name:
- 4B-Acid
- IUPAC Name:
- 4B-Acid
- Details on test material:
- Purity: 98,9%
Constituent 1
Constituent 2
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
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