Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate

Endpoint summary

Description of key information

The source substance SMCT does not induce any signs of sensitization in animals when evaluated in the Buehler test and the sensitization incidence was 0 %.

Hence based on read-across, SMLT is not expected to be a skin sensitiser.

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:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across study

Justification for type of information:

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Refer to section 13 for read-across justification.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Justification for non-LLNA method:

Historically available non-LLNA test

Species:

guinea pig

Strain:

other: Pirbright-White

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG. SPF breeding (Hoe:DHPK[SPFLac])
- Weight at study initiation: 299g (264 - 327 g)
- Housing: Macrolon cages (type 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 hours

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Topical induction: 100 %
Topical challenge: 20%

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Topical induction: 100 %
Topical challenge: 20%

No. of animals per dose:

20 for test group
10 for control group

Details on study design:

RANGE FINDING TESTS: yes, determination of primary irritating and non-irritating concentration

Challenge controls:

yes, negative control group

Positive control substance(s):

yes

Remarks:

alpha-hexylcinnamaldehyde

Positive control results:

Sensitivity of test system periodically confirmed using alpha-hexylcinnamaldehyde as positive control.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

20%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

20%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

data not available

No. with + reactions:

0

Total no. in group:

0

Clinical observations:

data not available

Remarks on result:

other: data not available

Reading:

1st reading

Hours after challenge:

48

Group:

positive control

Dose level:

data not available

No. with + reactions:

0

Total no. in group:

0

Clinical observations:

data not available

Remarks on result:

other: data not available

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the study results, the read-across source substance sodium methyl cocoyl taurate (SMCT) is not a skin sensitizer in the Buehler test.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is not expected to be a skin sensitiser.

Executive summary:

The skin sensitization potential of the read-across source substance sodium methyl cocoyl taurate (SMCT) was evaluated for potential skin sensitizing effects in guinea pigs according to OECD Guideline 406 using the methodology of Buehler. Dermal induction was performed using 100% test material. The control group was exposed to the vehicle water only. Challenge treatment was carried out using a 20% test material in water as vehicle. Under the conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitization incidence = 0%). Also none of the 10 control animals exhibited skin responses. Based on the results of this study, SMCT is not a skin sensitizer.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is not expected to be a skin sensitiser.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitization potential of the read-across source substance sodium methy cocoyl taurate (SMCT) was evaluated for potential skin sensitizing effects in guinea pigs according to OECD Guideline 406 using the methodology of Buehler. Dermal induction was performed using 100% test material. The control group was exposed to the vehicle water only. Challenge treatment was carried out using a 20%test material in water as vehicle.Under the conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitization incidence = 0%). Also none of the 10 control animals exhibited skin responses. Based on the results of this study, SMCT is not a skin sensitizer.

Short description of key information:
The source substance SMCT does not induce any signs of sensitization in animals when evaluated in the Buehler test and the sensitization incidence was 0 %. Hence based on read-across, SMLT is not expected to be a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Guideline read-across study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements. See section 13 for full read-across justification.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Based on read-across to SMCT, the registration/target substance SMLT is not expected to be a skin sensitizer. None of the available toxicological data and known exposure conditions indicates concern that it may possess respiratory sensitization properties.

Justification for classification or non-classification

Based on all available data the registered substance is not a skin sensitiser and therefore is not subject for classification and labelling requirements.