Registration Dossier

Administrative data

Description of key information

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:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
The LLNA was not available at time of study implementation. Existing data from Buehler study scientifically adequate.
Species:
guinea pig
Strain:
other: Himalayan spotted
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Füllinsdorf, Switzerland
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 328 - 422 g
- Housing: Makrolon cages (type 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12 hours

Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Topical induction: 50% in PEG 300
Topical challenge: 50% in PEG 300
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Topical induction: 50% in PEG 300
Topical challenge: 50% in PEG 300
No. of animals per dose:
Test group: 20 animals
Control group: 10 animals
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Once a week for a 3-week induction phase
- Exposure period: 6 hours each
- Test groups:20 animals
- Control group: 10 animals
- Site: left shoulder
- Frequency of applications: once per week for 3 a 3-week period
- Concentrations: 50% in PEG 300

B. CHALLENGE EXPOSURE
- No. of exposures: Once
- Day(s) of challenge: on day 29
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left posterior of the side and back
- Concentrations: 50% in PEG 300
- Evaluation (hr after challenge): 24 and 48 hours

Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde
Positive control results:
Twenty (24 hour reading) and nineteen (48 hour reading) out of 20 animals exhibited discrete/patchy to moderate/confluent erythema after challenge treatment of alpha-hexylcinnamaldehyde at 5% in PEG 300.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% in PEG 300
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: 50% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in PEG 300. 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:
50% in PEG 300
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: 50% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% in PEG 300. 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:
5% in PEG 300
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 5% in PEG 300. No with. + reactions: 20.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5% in PEG 300
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5% in PEG 300. No with. + reactions: 19.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results, the test substance is not a skin sensitizer in the guinea pig (incidence 0%)
Executive summary:

The skin sensitization potential of sodium methyl oleyl taurate 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 50% test material in PEG 300. The control group was exposed to vehicle only. Challenge treatment was carried out using also 50% test material in PEG 300.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, the test substance is not a skin sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitization potential of the registration substance 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 50%test material in PEG 300. The control group was exposed to vehicle only. Challenge treatment was carried out using also 50%test material in PEG 300.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, the test substance is not a skin sensitizer.


Migrated from Short description of key information:
The registered substance does not induce any signs of sensitization in animals when evaluated in the Buehler test. The sensitization incidence was 0 %.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The registration substance is not a skin sensitizer. None of the available toxicological data and known exposure conditions indicates concern that it may possess respiratory sensitization properties.


Migrated from Short description of key information:
The registration substance is not a skin sensitizer. None of the available toxicological data and known exposure conditions indicates concern that it may pose a respiratory sensitization risk.

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.