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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 16 -4-AMINOTOLUENE-3-SULFONIC ACID, 27-30 May 2003
Author:
OECD SIDS
Year:
2003
Bibliographic source:
SIDS Initial Assessment Report For SIAM 16 -4-AMINOTOLUENE-3-SULFONIC ACID, OECD SIDS, 27-30 May 2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: accordance with IMDG Code 2002
Principles of method if other than guideline:
Patch test was performed humans to assess the irritation potential of 4-aminotoluene-3-sulfonic acid
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid
Details on test material:
Name of test material : 6 –amino-m-Toluenesulfonic acid
Molecular formula : C7H9NO3S
Molecular weight : 187.23 g/mol
Substance type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of test material : 6 –amino-m-Toluenesulfonic acid
Molecular formula : C7H9NO3S
Molecular weight : 187.23 g/mol
Substance type: Organic
Physical State: Solid
purity: >99%

Test animals

Species:
other: human
Strain:
not specified
Details on test animals and environmental conditions:
male: age 27-48

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Dose: ca. 50 mg/patch (direct) on an inner arm
Duration of treatment / exposure:
6 hours
Observation period:
post dose 14 days
Number of animals:
5
Details on study design:
no data availale

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 6 hr
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
6 –amino-m-Toluenesulfonic acid was not irritating to the skin of humans in 6hr patch test performed in accordance with IMDG Code 2002
Hence, 6 –amino-m-Toluenesulfonic acid can be considered not irritating to skin.
Executive summary:

Patch test was performed on humans in accordance with IMDG code (2002) to assess the irritation potential of 4-aminotoluene-3-sulfonic acid. 50 mg/patch was applied under occlusive conditions to the inner arm of 5 male volunteers for 4 hours.The test site was observed for erythema and edema till 14 days post dosing.

6 –amino-m-Toluenesulfonic acid was not irritating to the skin of humans in 6hr patch test. Hence, 6 –amino-m-Toluenesulfonic acid can be considered not irritating to skin.