Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate

Endpoint summary

Description of key information

A Modified Draize-Shelanski Repeat Insult Patch Test was carried out to test for sensitisation (Induction 2.5 % in petrolatum, Challenge 1% in petrolatum) .There was no irritation or sensitisation from this material.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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 deviates from the current LLNA standard method, but was conducted according to standards at the time of conduct. The study is therefore considered adequate, relevant and reliable.

Qualifier:

according to guideline

Guideline:

other: Modified Draize-Shelanski Repeat Insult Patch test

Deviations:

no

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:

other: Modified Draize-Shelanski Repeat Insult Patch Test

Justification for non-LLNA method:

The Modified Draize-Shelanski Patch test was historically present for the registered substance and was considered most relevant and valid.

Species:

human

Strain:

other: not applicable

Sex:

male/female

Details on test animals and environmental conditions:

Not applicable

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

Induction 2.5 % in petrolatum
Challenge 1% in petrolatum

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

Induction 2.5 % in petrolatum
Challenge 1% in petrolatum

No. of animals per dose:

100 humans

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 100
- Exposure period: 24 hours
- Test groups: 1 test group of 100 humans
- Control group: no
- Site: patch sites on the back or volar forearms
- Frequency of applications: 10
- Duration: 10 alternate days
- Concentrations: 2.5% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 100
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: humans , 1 test group
- Control group: no
- Site: back or volar forearms, fresh sites
- Concentrations: 1% in petrolatum
- Evaluation (hr after challenge):24h and 48 hours

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1% in petrolatum

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: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 100.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1% in petrolatum

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: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 100.0.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Remarks on result:

not measured/tested

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Remarks on result:

not measured/tested

Reading:

1st reading

Group:

positive control

Remarks on result:

not measured/tested

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Remarks on result:

not measured/tested

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

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:

Modified Draize-Shelanski Repeat Insult Patch Test:

Approximately 300 mg of the test item, containing >96% active ingredient, was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion.

Following a seven-day rest period, challenge patches of the test item 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.

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

It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A Modified Draize-Shelanski Repeat Insult Patch Test was carried out with registered substance as a key test to investigate sensitisation with a test item containing > 96% active ingredient (Kligman 1976). Approximately 300 mg of the test material (2.5% test material in petrolatum) was applied as induction to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches (1% test material in petrolatum) 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. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

Further information supporting the absende of sensitisation potential is provided in the read across justification for the Diester category, showing that all substances in the group were negative for human patch testing on the human arm skin (justification with data matrix separately attached in Section 13).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

As there was no indication for sensitisation from the Human Patch test for current substance and category analogues, classification for skin sensitisation is not needed according to CLP (No. 1272/2008 of 16 December 2008).