Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)

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:

comparable to guideline study with acceptable restrictions

Justification for type of information:

No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128-49-4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

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:

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)

Test material

Test material information

Constituent 1

Reference substance name:

Docusate sodium

EC Number:

209-406-4

EC Name:

Docusate sodium

Cas Number:

577-11-7

Molecular formula:

C20H38O7S.Na

IUPAC Name:

sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate

Details on test material:

- Name of test material (as cited in study report):AEROSOL ® OT
- Physical state: white waxy solid
- Batch No.:
- Analytical purity: 100%

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)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Induction 2

Concentration / amount:

0.30 g of 2.5% AEROSOL ® OT dispersion in petrolatum (Induction)
0.30 g of 1% AEROSOL ® OT in petrolatum(Challenge)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

0.30 g of 2.5% AEROSOL ® OT dispersion in petrolatum (Induction)
0.30 g of 1% AEROSOL ® OT in petrolatum(Challenge)

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.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

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

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 300 mg. No with. + reactions: 0.0. Total no. in groups: 100.0. Clinical observations: none.

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:

none

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: none.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

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:

No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128-49-4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.

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.