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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
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

Test guideline
Qualifier:
no guideline available
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
Type of study:
patch test

Test material

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
IUPAC Name:
sodium 4-icosylbenzenesulfonate
Details on test material:
the test substance was a similar material to the registered substance (aryl alkyl sulphonate)
- Other: Brown viscous liquid

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: mineral oil
Concentration / amount:
10%
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: mineral oil
Concentration / amount:
10%
Details on 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
- Day(s) of challenge:
- 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

Study design: in vivo (LLNA)

Statistics:
Use of statistics not indicated.

Results and discussion

Any other information on results incl. tables

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

Interpretation of results:
not sensitising
Remarks:
Migrated information EU
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.

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