Sodium 1,2-diisobutoxycarbonylethanesulphonate

Endpoint summary

Description of key information

A modified Draize-Shelanski Repeat Insult Patch Tests was carried out to test for sensitisation with a batch containing 44-46% active ingredient. There was no irritation or sensitisation from this material on the Draize-Shelanski Test.

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:

1977

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 for classification.

Qualifier:

according to guideline

Guideline:

other: Modified draize-Shelanski 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 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:

Aerosol IB is an aqueous solution of sodium di-isobutyl sulfosuccinate.The sample used in the patch tests was 45 % real.
For use in the test, 2.5% and 1.0% by weight dispersions of Aerosol IB in petrolatum were prepared. Each induction application consisted of about 0.30g of the 2.5% petrolatum dispersion.
Each challenge application consisted about 0.30g of the 1.0% petrolatum dispersion.

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

Aerosol IB is an aqueous solution of sodium di-isobutyl sulfosuccinate.The sample used in the patch tests was 45 % real.
For use in the test, 2.5% and 1.0% by weight dispersions of Aerosol IB in petrolatum were prepared. Each induction application consisted of about 0.30g of the 2.5% petrolatum dispersion.
Each challenge application consisted about 0.30g of the 1.0% petrolatum dispersion.

No. of animals per dose:

100 humans

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 10 alternate-day 24 hour period
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: patch sites on the back or volar forearms
- Duration: 10 days
- Concentrations: about 0.30g of the 2.5% petrolatum dispersion of Aerosol IB

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- 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: about 0.30g of the 1.0% petrolatum dispersion of Aerosol IB
- Evaluation (hr after challenge): 24 and 48 hours

Modified Draize-Shelanski Repeat Insult Patch Test: A 15 mm patch 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, 15mm 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, using the 0-4 scale.

Key result

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.

Key result

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.

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Remarks on result:

not measured/tested

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Remarks on result:

not measured/tested

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Remarks on result:

not measured/tested

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Remarks on result:

not measured/tested

Interpretation of results:

not sensitising

Remarks:

Criteria used for interpretation of results: expert judgment

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:

A modified Draize-Shelanski Repeat Insult Patch Test with a 15 mm patch with 300 mg test item (2.5% test item containing 44 -46% act. ingr.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, 15 mm challenge patches (1.0 % test item containing 44 -46% act. ingr. in petrolatum) of the test item 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 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Human patch testing

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 44 -46% active ingredient (Kligman, 1977). The study design was as follows: a 15 mm patch with 300 mg test item (2.5% test item) 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, 15 mm challenge patches (1% test item) 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 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.

 

Conclusion

- Based on the Patch testing, tt is unlikely that this material would present irritation or sensitisation in normal, intended use.

- Further information supporting the absence of sensitisation potential is provided in the read across justification for the Di-ester 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, classification for sensitisation is not warranted according to the CLP (No. 1272/2008 of 16 December 2008).