lithium 3-((3,4-dicyanophenyl)sulfonyl)propane-1-sulfonate)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Remarks:

A confirmatory skin sensitisation patch test of a single worker.

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 07 Sept. 2018 to 11 Sep. 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

Following a report of symptoms associated with skin sensitisation in one industrial worker (at a plant manufacturing the test material), a confirmatory human patch test was carried out. The test was was carried out for occupational health reasons, it was not carried out for the purposes of the REACH registration, nor to confirm the classification and labelling of the test material.

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

Principles of method if other than guideline:

It was confirmed that the patch test that was carried out was a standard recognised test. Patch testing was carried out to the Euopean standard battery, a variety of cosmetic allergens and to the test material, S193308.
The test material was applied to the subject in a staged approach. 0.1% of the test material was applied to the subject at 0 hours. These patches were removed after 48 hours and any reactions recorded. As no reactions were observed at 48 hrs to the 0.1% concentration, 0.5% of the test material was applied to the subject. After 96 hours (after the initial application of the 0.1% test material) the patches for the 0.5% test material were removed. Observations were recorded for both the 0.1% and 0.5% test concentrations.

GLP compliance:

not specified

Test material

Test material information

Test material form:

not specified

Method

Type of population:

occupational

Ethical approval:

confirmed, but no further information available

Subjects:

- Number of subjects exposed: 1
- Sex: male
- Age: 18-65
- Industrial worker

Clinical history:

- History of allergy or casuistics for study subject or populations: no history of allergy in subject
- Symptoms, onset and progress of the disease: Subject reported facial and hand dematitis and dry eyes, getting progressively worse over the course of four shifts.
- Exposure history: Subject has worked with the test substance for a number of years (exact number unspecified).
- Aggravating factors both in home and workplace: not known
- Family history: not known
- Any other allergic or airway disorders: not known
- Smoking history: not known

Controls:

not known

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: IQ Ultra patch test units by Chemotechnique (supplied by Crawford Healthcare) (approx 1cm square).
- Vehicle / solvent: Petroleum Jelly
- Concentrations: 0.1% test material at 0 Hours. 0.5% test material at 48 hours.
- Volume applied: ~35 mg
- Testing/scoring schedule: Reactions recorded at 48 and 96 hours. macular erythema record as a +/-. Palpable erythema recorded as +. Palpable erythema extending beyond the test site recorded as ++ and bullae/vesiculation recorded as +++.
- Removal of test substance: Any residue present on removal of patch would be wiped away, the area was not washed.

The test material was applied to the subject in a staged approach. 0.1% of the test material was applied to the subject at 0 hours. These patches were removed after 48 hours and any reactions recorded. As no reactions were observed at 48 hrs to the 0.1% concentration, 0.5% of the test material was applied to the subject. After 96 hours (after the initial application of the 0.1% test material) the patches for the 0.5% test material were removed. Observations were recorded for both the 0.1% and 0.5% test concentrations.

EXAMINATIONS
Examinations were carried out at 48 and 96 hours after the initial patches were applied.

Results and discussion

Results of examinations:

RESULT OF CASE REPORT:
At 96 hours (96h after application of the 0.1% test material, 48h after application of the 0.5% test material) clear positive reactions were observed for both the 0.1% and 0.5% applications. A back flare in periocular dermatitis was also observed.
At 48 hours (after application of the 0.1% test material) no reactions were observed.

The test subject had a ++ reaction to 0.5% of test material at 96hrs.

A skin survey of industrial workers at the same plant (test material is only handled at one site) has shown no additional cases.

Applicant's summary and conclusion

Conclusions:

The subject had a clear positive result to 0.5% of the test material 48 hours after exposure. The test subject also experienced a back flare in periocular dermatitis which confirmed an allergy to the test material.

Executive summary:

Introduction

A patch test study was undertaken to confirm a single case of allergic contact dermatitis in an industrial worker.

Results and Conclusion

The subject had a clear positive result to 0.5% of the test material 48 hours after exposure.The test subject also experienced a back flare in periocular dermatitis which confirmed an allergy to the test material.

A skin survey of industrial workers at the same plant (test material is only handled at one site) has shown no additional cases of skin sensitisation.