Sodium hydrogensulphate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

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

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The report is incomplete and unsigned. Lab and authors are unknown and there is no quality control. Individual data are not shown.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Patch Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

bath salt crystals containing 80.8 % sodium sulfate

IUPAC Name:

bath salt crystals containing 80.8 % sodium sulfate

Details on test material:

Bath salt crystals allegedly containing 80.8% sodium sulfate.

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 56 males and 5 females
- Age: 16-70

Route of administration:

dermal

Details on study design:

- Study type: Patch test.
- Preparation of test substance for induction: A 1.25% aqueous solution was prepared. This concentration represents a 100 fold increase of the normal use level. 
- Induction schedule: Subjects were exposed on their backs. The test patch unit consited of a strip of two-inch wide blenderm surgical tape with two rows of five 12.7 mm filter paper discs each. The first application lasted for 48 hours. All other inductions were for 24 hours. Reactions tohe initial site were scored 48 and 96 hours after patch removal. 8 other 24 hour inductions were done on mondays, Wednesdays and Fridays (3.5 weeks)on 3 alternate sites (unless the reaction or tape irritation was severe than other sites were used). Reactions were recorded 3-9 hours before application and 24 hours after patch removal.   
- Concentrations used for induction: 1.25% aqueous solution.
- Concentration in Freuds Complete Adjuvant (FCA): -
- Challenge schedule: On monday in week 7 subjects were challenged on a previously unpatched site. After 48 hours the patches were removed. The patches were scored 48 hours 48 following removal.
- Concentrations used for challenge: 1.25% aqueous solution.
- Rechallenge: subjects that showed signs of sentisation in the challenge phase were tested again after a 2 week rest period.   At the original concentration under occlusion, in a dilution of original strenght (1:3) under occlusion, as used in practice (subject applied the project to the flex part of the arm 3 times/day for 5 days.  

EXAMINATIONS
- Grading system:  patch reactions were scored by experienced technitians. According to the following scoring system:
0   No evidence of any effect +/- Barely perceptible. Minimal faint unifrom spotty erythema.
1   Mild. Pink unifrom erythema covering most of the contact site.
2   Moderate. Pink-red erythema visibly uniform in the whole contact site.
3   Marked. Bright red erythrema with accompanying edema, petechiae or papules.
4   Severe. Deep red erythema with vesiculation or weeping with or without edema. 
- Pilot study: -

Results and discussion

Results of examinations:

RESULTS OF PILOT STUDY: -
RESULTS OF TEST
- Sensitization reaction: One subject showed a score 1 reaction during the induction period. Other subjects did not react to the application (data not shown).
- Clinical signs: Mild. Pink unifrom erythema covering most of the contact site.
- Rechallenge: Data not shown.

Applicant's summary and conclusion

Conclusions:

Classification: not sensitizing