Registration Dossier
Registration Dossier
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EC number: 290-836-4 | CAS number: 90268-36-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- 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:
- 1 976
- 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 Modified Draize-Shelanski Repeat Insult Patch Test was conducted in 1975.
Test material
- 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: 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
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: healthy adults
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 300mg of test item, 2.5% in petrolatum
- Day(s)/duration:
- 10 alternate-day 24 hour periods
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 300mg of test item 1% in petrolatum
- Day(s)/duration:
- 1 day (24 hours)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 100
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 100
- 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 test item 2.5% in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: 100
- 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 tet item 1% in petrolatum
- Evaluation (hr after challenge): 24 and 48 hours
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 300 mg
- No. with + reactions:
- 0
- Total no. in group:
- 100
- Clinical observations:
- 0
- Key result
- 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
- Key result
- Reading:
- other: 1st and 2nd reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Key result
- 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 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.
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