3,5-diaminobenzoic acid

Skin irritation / corrosion

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

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

Test material information

Constituent 1

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

IUPAC Name:

2-amino-5-methylbenzenesulfonic acid

Constituent 2

Reference substance name:

6 –amino-m-Toluenesulfonic acid

IUPAC Name:

6 –amino-m-Toluenesulfonic acid

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 or test system 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.