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Diss Factsheets

Administrative data

Description of key information

Sensitisation studies according to the modified Draize-Shelanski Repeat Insult Patch Test were negative for skin sensitisation for docusate sodium and for various category members as supporting information.  Therefore it is unlikely that docusate sodium has sensitization potential for the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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, but differs from current methods.
Justification for type of information:
The Human insult patch test was historically present for the substance and was considered to be most relevant and valid.
Qualifier:
according to guideline
Guideline:
other: Modified Draize-Shelanski Repeat Insult Patch Test
Principles of method if other than guideline:
Human predictive skin sensitisation tests have been in use the last 50 years. They have been used more widely in the United States than in Europe. Sensitisation potential has been investigated, and the development of animal sensitisation tests was partly based on comparison to human tests performed with the same chemicals. Further, human testing has the advantage that extrapolation of the test results from one species to another is avoided. There are a number of different human sensitisation tests available.(http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/sccnfp_opinions_97_04/sccp_out102_en.htm)
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
The Human insult patch test was historically present for the substance and was considered to be most relevant and valid.
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
Not applicable
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.30 g of 2.5% AEROSOL ® OT dispersion in petrolatum (Induction)
Day(s)/duration:
ten alternate-day 24 hour period
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.30 g of 1% AEROSOL ® OT in petrolatum(Challenge)
Day(s)/duration:
24 hours
No. of animals per dose:
100 humans
Details on study design:
Modified Draize-Shelanski Repeat Insult Patch Test: Aproximately 300 mg of the test material was applied to 15 mm 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.
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:
none
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:
none
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not applicable
Remarks on result:
other: A positive control group is not included in a human patch test for ethical reasons.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not applicable
Remarks on result:
other: A positive control group is not included in a human patch test for ethical reasons.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not apllicable
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not applicable
Interpretation of results:
not sensitising
Conclusions:
Mild erythema was seen in 19 of 100 subjects after induction, however there were no instances 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.
Executive summary:

A15 mm patch of the test material was applied to patch sites on the back of volar forearms of 100 subjects for 10 alternate-day 24 hour periods under occlusion. Following a 7-day rest period, 15 mm challenge patches of the material were applied in the same manner to fresh sites on the backs 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 some subjects with mild erythema after induction, however there were no instances 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A key sensitisation study for docusate sodium was conducted according to the modified Draize-Shelanski Repeat Insult Patch Test with approximately 300 mg docusate sodium applied to patch sites on the backs or volar forearms of 100 human subjects for ten alternate-days during 24 hour periods under occlusion (Cytec, Kligman 1977). Following a seven-day rest period, challenge patches of the material were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter. Although some subjects had mild irritation during induction, there was no sensitisation after challenge.

Sensitisation assays were also available from category members as supporting information. 

·        For a formulated product containing 44-46% CAS No. 127-39-9 (sodium di-iso-butyl sulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1977).

·        For a formulated product containing 78-80% CAS No. 2373-38-8 (sodium dihexylsulfosuccinate), there were no instances of irritation or sensitization. (Cytec, Kligman 1976a).

·        For a formulated product containing approximately 70% CAS No. 2763 -22 -5 (bis (tridecyl) sodium sulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1976b).

·        For a test substance with >97% CAS No. 922-80-5 (sodium diamylsulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1976c).

 

In summary, no skin sensitization was observed with docusate sodium and structural similar chemicals, hence it is unlikely that docusate sodium has sensitization potential. Further testing is not recommended/proposed based on this information.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

As there was no skin sensitisation observed, there is no indication for classification.