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Administrative data

Endpoint:
skin sensitisation
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: Study non-GLP with limited data on study design, however the study was conducted to state of the art methods at that time period. The study is therefore considered adequate, reliable and relevant.

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
GLP compliance:
no
Type of study:
other: Modified Draize-Shelanski Repeat Insult Patch Test

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
EC Number:
213-085-6
EC Name:
Sodium 1,2-bis(pentyloxycarbonyl)ethanesulphonate
Cas Number:
922-80-5
Molecular formula:
C14H26O7S.Na
IUPAC Name:
sodium 1,4-dioxo-1,4-bis(pentyloxy)butane-2-sulfonate
Test material form:
other: waxy solid
Details on test material:
- Name of test material (as cited in study report):AEROSOL ® AY; Sodium Diamyl Sulfosuccinate
- Physical state: Waxy solid
- Analytical purity: >97 %
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: S-11700-88-B (product code 24906-01)
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
Not applicable

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% AEROSOL ® AY in petrolatum (Induction)
1% AEROSOL ® AY in petrolatum (Challenge)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% AEROSOL ® AY in petrolatum (Induction)
1% AEROSOL ® AY in petrolatum (Challenge)
No. of animals per dose:
100
Details on study design:
Modified Draize-Shelanski Repeat Insult Patch Test: Aproximately 300 mg of the test material was 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, challenge patches 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.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge)
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge). No with. + reactions: 0.0. Total no. in groups: 100.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge)
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge). No with. + reactions: 0.0. Total no. in groups: 100.0.

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 sensitization from this test item on the Draize-Shelanski Test.
It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.
Executive summary:

In a Modified Draize-Shelanski Repeat Insult Patch Test aproximately 300 mg of the test item containing > 97% active ingredient (2.5% in petrolatum) was 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, challenge patches of the test item (1% in petrolatum) 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. There were no instances of irritation of sensitization from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.