Butanedioic acid, 2-sulfo-, mono(C16-18 and C18-unsatd. alkyl) esters, ammonium sodium salts

Endpoint summary

Description of key information

Two modified Draize-Shelanski Repeat Insult Patch Tests were carried out to test for sensitisation with a read across substance (CAS 37294-89-8 or disodium C-isodecyl sulphonatosuccinate): one with a batch containing > 90% active ingredient and one with 37% active ingredient. In both studies, 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.

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, and 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

GLP compliance:

no

Type of study:

other: Modified Draize-Shelanski Repeat Insult Patch Test

Justification for non-LLNA method:

The study was conducted before the LLNA was proposed as standard assay.

Species:

human

Strain:

other: healthy adults

Sex:

male/female

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

2.5% Induction
1% Challenge

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

2.5% Induction
1% Challenge

No. of animals per dose:

100

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 alternate-day 24 hour periods
- Exposure period: 1 day (24 hours)
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: patch sites on the back or volar forearms
- Frequency of applications: 10 applications
- Duration: 10 days
- Concentrations: 300mg of Aerosol® A-268 2.5% in petrolatum

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: 300mg of Aerosol® A-268 1% in petrolatum
- Evaluation (hr after challenge): 24 and 48 hours

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

300mg

No. with + reactions:

0

Total no. in group:

100

Clinical observations:

0

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 300mg . No with. + reactions: 0.0. Total no. in groups: 100.0. Clinical observations: 0.

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:

0

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: 0.

Reading:

other: 1st and 2nd reading

Group:

negative control

Remarks on result:

not measured/tested

Reading:

other: 1st and 2nd reading

Group:

positive control

Remarks on result:

not measured/tested

Interpretation of results:

not sensitising

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Test.
It is unlikely that thistest item would present a danger of irritation or sensitisation in normal, intended use.

Executive summary:

A modified Draize-Shelanski Repeat Insult Patch Test was conducted with a 15 mm patch with 300 mg test material (2.5% test material with 90% act. ingr.) 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 material with 90% act. ingr.) 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 material 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:

Sensitisation data were not available for the registered substance, however read across data were available from a category member, CAS No. 37294 -49 -8 (Disodium C-isodecyl sulphonatosuccinate).

 

Human patch testing:

Two modified Draize-Shelanski Repeat Insult Patch Tests were carried out to test for sensitisation: in the first study a batch with > 90% active ingredient was used (key study: Kligman, 1976); in the second study a batch with 37% active ingredient was used (Kligman, 1977). The study design was as follows: a 15 mm patch with 300 mg test material (2.5% 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, 15 mm challenge patches (1% test material) 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.

In both studies, there were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.

 

Conclusion

- Based on negative outcome of skin potential in human Patch testing with read-acros substance, it is unlikely that the registered substance would present a danger of irritation or sensitisation in normal, intended use.

- This was further supported by negative data from human patch testing, as documented in the read-across justification (see Section 13).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data from read across, there was no indication for sensitisation from the Human Patch Test, classification for sensitisation is not warranted.