5-amino-2-methoxybenzenesulphonic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal.

Data source

Reference

Reference Type:

publication

Title:

Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods.

Author:

Gerberick GF, Ryan CA, Kern PS, Schlatter H, Dearman RJ, Kimber I, Patlewicz GY, Basketter DA.

Year:

2005

Bibliographic source:

Dermatitis, 2005 Dec; 16(4):157-202

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Principles of method if other than guideline:

The skin sensitizing potential of the test chemical Vanillin (CAS No: 121-33-5) was assessed by using the Mouse Local Lymphnode Assay.

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Vanillin

EC Number:

204-465-2

EC Name:

Vanillin

Cas Number:

121-33-5

Molecular formula:

C8H8O3

IUPAC Name:

1-butoxypropan-2-ol

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Vanillin
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: organic
- Physical state: Solid
-Smiles: c1(cc(ccc1O)C=O)OC
-InChI: 1S/C8H8O3/c1-11-8-4-6(5-9)2-3-7(8)10/h2-5,10H,1H3

Specific details on test material used for the study:

- Name of test material (as cited in study report): Vanillin
- Molecular formula: C8H8O3
- Molecular weight: 152.1482 g/mol
- Substance type: organic
- Physical state: Solid
-Smiles: c1(cc(ccc1O)C=O)OC
-InChI: 1S/C8H8O3/c1-11-8-4-6(5-9)2-3-7(8)10/h2-5,10H,1H3

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Age at study initiation: 7-12 weeks

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

25 µl

No. of animals per dose:

No data

Details on study design:

Treatment was performed daily for 3 consecutive days. Five days after initiation of exposure all mice were injected via the tail vein with 250µl of PBS containing 20µCi of tritiatied thymidine. The mice were sacrificed 5 hours later, and draining the auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by β-scintillation counting and was reported in disintegrations /minute. An SI was calculated for each chemical group as the ratio of disintegrations/minute of the treated group to the disintegrations/minute of the concurrent vehicle control group. A substance was classified skin sensitizer , if at one or more than one concentrations, it induced a three-fold or greater increase in local lymph node proliferative activity when treated with the concurrent vehicle treated controls (SI ≥3)

Positive control substance(s):

not specified

Statistics:

The approach to estimation of the relative skin sensitization potential is based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value

Refer Table 1 and 2 for more information

Results and discussion

In vivo (LLNA)

Results

Parameter:

EC3

Value:

100

Remarks on result:

other: The relative potency index of Vanillin was not calculated but on the basis of classification system it was considered to be >100.

Cellular proliferation data / Observations:

The relative potency index of Vanillin was not calculated but on the basis of classification system it was considered to be >100.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

The relative potency index of Vanillin (CAS No: 121-33-5) was estimated to be >100. Based on the relative potency index Vanillin (CAS No: 121-33-5) was considered as non skin sensitizer

Executive summary:

The skin sensitizing potential of the test chemical Vanillin (CAS No: 121-33-5) was assessed by using the Mouse Local Lymphnode Assay.

 

The LLNA was conducted on groups of CBA mice (7-12 weeks of age) by mean of topical application of chemical on the dorsum of both ears at a dose of 25µl or to an equal volume of relevant vehicle (Acetic acid in olive oil (4:1))only. Treatment was performed daily for 3 consecutive days. Five days after initiation of exposure all mice were injected via the tail vein with 250µl of PBS containing 20µCi of tritiatied thymidine. The mice were sacrificed 5 hours later, and draining the auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by β-scintillation counting and was reported in disintegrations /minute.

 

 An SI was calculated as the ratio of disintegrations/minute of the treated group to the disintegrations/minute of the concurrent vehicle control group.

 

A substance was classified skin sensitizer , if at one or more than one concentrations, it induced a three-fold or greater increase in local lymph node proliferative activity when treated with the concurrent vehicle treated controls (SI ≥3)

 

The approach to estimation of the relative skin sensitization potential is based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value.

 

The relative potency index of Vanillin (CAS No: 121-33-5) was not calculated but on the basis of classification system it was considered to be >100. Thus the chemical Vanillin (CAS No: 121-33-5) was considered as non skin sensitizer.