Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Remarks:

HRIPT

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.

Cross-reference

Reason / purpose for cross-reference:

read-across source

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

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 4-[(8-methylnonyl)oxy]-4-oxo-2-sulfonatobutanoate

Test material form:

other: liquid

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

Results and discussion

Positive control results:

Not performed.

In vivo (non-LLNA)

Results

Reading:

other: after patch removal and 24h after patch removal

Dose level:

see report

No. with + reactions:

0

Total no. in group:

100

Remarks on result:

other: see report

Any other information on results incl. tables

There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Test.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information 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 this test 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.