Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

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:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to guideline and to GCP and adequately reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A nine Repeated Insult (semi-occlusive) Patch Test was conducted. A sufficient quantity of the test material was applied directly to the skin with a cotton-tipped applicator. In addition, a thin layer was placed onto a 2 cm x 2 cm square of Webril cotton fabric affixed semi-occlusive surgical tape which was applied to the back of each subject. Subjects removed the patch 24 hours after application. Twenty-four hours rest followed the Tuesday and Thursday removals and 48 hour rest periods followed each Saturday removal. This continued until 9 applications had been made.

After a rest period of 2 weeks, the challenge patch was applied to a previously unpatched test site. The site was scored 24 and 72 hours after application.

GLP compliance:

yes

Remarks:

Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

EC Number:

274-263-7

EC Name:

Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts

Cas Number:

70024-69-0

Molecular formula:

Cannot be adequately determined for this UVCB substance

IUPAC Name:

Petroleum, mono-C16-24 linear saturated alkaryl derivatised benzenesulphonic acid calcium salts

Details on test material:

- Other: Brown viscous liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Sex: male and female

Route of administration:

dermal

Details on study design:

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

TEST SYSTEM:
- Concentration: 10 %
- Vehicle: mineral oil
- Route of induction exposure: epicutaneous, semiocclusive
- Route of challenge exposure: epicutaneous, semiocclusive

STUDY DESIGN:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: nine
- Exposure period: 24 hours
- Test groups: 8 males, 45 females. 5 subjects discontinued.
- Control group: none
- Site: between the scapulae and the waist, adjacent to the spinal mid line
- Frequency of applications: Monday, Wednesday, Friday
- Duration: 3 weeks
- Concentrations: 10%

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Exposure period: 72 hours
- Test groups: 8 males, 45 females
- Control group: none
- Site: previously unpatched site between the scapulae and the waist, adjacent to the spinal mid line
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 72 hours

Results and discussion

Results of examinations:

Subject number 1 was discontinued due to induction patch dermal reactivity suggestive of a moderate grade induced allergic contact dermatitis. This skin reactivity pattern was characterised by 5 consecutive negative induction patch responses, followed by moderate erythema. Following a change in patch site, moderate erythema was again elicited, accompanied by papules spreading beyond the actual contact site. This subject was not challenge-patched at the discretion of the Principal Investigator.

Subject numbers 2 and 42 exhibited similar induction patch reativity and did not receive further induction or challenge patches at the discretion of the Principal Investigator. There was no other dermal reactivity observed on any other test subject during the course of the study.

Applicant's summary and conclusion

Conclusions:

Dermal reactivity suggestive of allergic contact dermatitis was observed in 3/48 test subjects. Sensitisation was not elicitied in a substantial number of persons.

Executive summary:

In a dermal sensitization study with  sodium 4-icosylbenzenesulfonate in mineral oil, (8 men and 45 women were tested using patch testing. Contact dermatitis was observed in 3/48 test subjects.  In this study, sodium 4-icosylbenzenesulfonate is not a dermal sensitizer.