Butanedioic acid, 2-sulfo-, mono(C16-18 and C18-unsatd. alkyl) esters, ammonium sodium salts

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test method is adequate and relevant, and was conducted according to standards at the time of conduct. The study is therefore considered adequate, relevant and reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Modified Draize-Shelanski Repeat Insult Patch Test

Deviations:

no

GLP compliance:

no

Type of study:

other: Modified Draize-Shelanski Repeat Insult Patch Test

Justification for non-LLNA method:

The study was conducted before the LLNA was proposed as standard assay.

Test material

Test material information

Constituent 1

Reference substance name:

Disodium C-isodecyl sulphonatosuccinate

EC Number:

253-452-8

EC Name:

Disodium C-isodecyl sulphonatosuccinate

Cas Number:

37294-49-8

Molecular formula:

C14H26O7S.2Na

IUPAC Name:

disodium C-isodecyl sulphonatosuccinate

Test material form:

other: waxy solid

Details on test material:

- Name of test material (as cited in study report): Aerosol® A-268
- Physical state: Waxy solid
- Analytical purity: > 90%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: S-11700-79-A
- Expiration date of the lot/batch: See confidential details
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

In vivo test system

Test animals

Species:

human

Strain:

other: healthy adults

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Induction 2

Concentration / amount:

2.5% Induction
1% Challenge

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

2.5% Induction
1% Challenge

No. of animals per dose:

100

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 alternate-day 24 hour periods
- Exposure period: 1 day (24 hours)
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: patch sites on the back or volar forearms
- Frequency of applications: 10 applications
- Duration: 10 days
- Concentrations: 300mg of Aerosol® A-268 2.5% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: After 7 days rest period
- Exposure period: 1 day (24 hours)
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: fresh patch sites on the back or volar forearms
- Concentrations: 300mg of Aerosol® A-268 1% in petrolatum
- Evaluation (hr after challenge): 24 and 48 hours

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

300mg

No. with + reactions:

0

Total no. in group:

100

Clinical observations:

0

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 300mg . No with. + reactions: 0.0. Total no. in groups: 100.0. Clinical observations: 0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

300 mg

No. with + reactions:

0

Total no. in group:

100

Clinical observations:

0

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 300 mg. No with. + reactions: 0.0. Total no. in groups: 100.0. Clinical observations: 0.

Results 3

Reading:

other: 1st and 2nd reading

Group:

negative control

Remarks on result:

not measured/tested

Results 4

Reading:

other: 1st and 2nd reading

Group:

positive control

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Test.
It is unlikely that thistest item would present a danger of irritation or sensitisation in normal, intended use.

Executive summary:

A modified Draize-Shelanski Repeat Insult Patch Test was conducted with a 15 mm patch with 300 mg test material (2.5% test material with 90% act. ingr.) applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, 15 mm challenge patches (1% test material with 90% act. ingr.) of the material were applied in the same manner to fresh sites on the back or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter, using the 0-4 scale. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.