Reaction mass of sodium 4-hydroxybenzenesulfonate and disodium 4-hydroxybenzene-1,3-disulfonate and sodium sulfate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Literature data

Data source

Reference

Reference Type:

publication

Title:

Identification of Metal Allergens in the Local Lymph Node Assay.

Author:

Basketter David A., Lea Linda J, Cooper Karen J., Ryan Cindy A., Gerberick G. Frank, Dearman Rebecca J. and Kimber Ian.

Year:

1999

Bibliographic source:

American joumal of Contact Dermatitis, Vol. 10, No 4 (December), 1999: pp 207-212

Materials and methods

Principles of method if other than guideline:

Protocol described in Basketter et al., 1992. The local lymph node assay (LLNA) was used to determine the skin sensitization potential of 13 metal salts, 8 of which were considered to possess a significant ability to sensitize man. Treatment was performed once daily for 3 consecutive days. In order to assign to the metal a classification relating to skin sensitization the general principles outlined for such purposes by the European Union (EU) and the World Health Organization have been followed.

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Details on test animals and environmental conditions:

TEST ANIMALS
- Number: 4
- Source: Harland, Olac, Bicester, United Kingdom
- Age at study initiation: 7 to 12 weeks of age

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

5.0, 10.0 and 25.0%

No. of animals per dose:

4

Details on study design:

MAIN STUDY
TREATMENT PREPARATION AND ADMINISTRATION:
- Application: 25 µL of test material prepared with an equal volume of vehicle alone and applied to dersum of both ears.
- Administration: treatment was performed once daily for 3 consecutive days.

5 days after the initiation of exposure all mice were injected by the tail vein with 250 µL, of phosphate-buffer saline (PBS) containing 20 µCi of tritiated thymidine (2 Ci/mmol; Amersham International, Amersham, UK).

Mice were killed 5 hours later and the draining lymph nodes excised and pooled. A single-cell suspension of lymph node cells was prepared by mechanical disaggregation. The lymph node cell suspension was washed twice in an excess of PBS and then precipitated with 5% trichloroacetic acid (TCA) at 4°C for 18 hours. Pellets were resuspended in TCA and the incorporation of tritiated thymidine measured by β-scintillation counting. A substance was regarded as a skin sensitizer if, at any test concentration, the proliferation in treated lymph nodes was threefold or greater than that in the concurrent vehicle treated controls.

Results and discussion

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: 1.3, 2.0, 2.3 10 % zinc sulfate = 1.41

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

not sensitising

Executive summary:

The local lymph node assay (LLNA) was used to determine the skin sensitization potential of 13 metal salts, 8 of which were considered to possess a significant ability to sensitize man. Treatment was performed once a day for 3 consecutive days. In order to assign to the metal a classification relating to skin sensitization the general principles outlined for such purposes by the European Union (EU) and the World Health Organization have been followed.

Result

Test substance resulted not sensitising.