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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from secondary literature (NTRL report)

Data source

Reference
Reference Type:
secondary source
Title:
HEALTH AND SAFETY STUDIES WITH ROBUST SUMMARIES FOR CAS no: 137-20-2
Author:
NTRL
Year:
2006
Bibliographic source:
NTRL report, EPA-HQ-OPPT-2005-0055, 2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin sensitization study of Sodium 2-(methyloleoylamino)ethane-1-sulphonate was performed in guinea pig
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
No data available

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-[methyloleoylamino]ethane-1-sulphonate
EC Number:
205-285-7
EC Name:
Sodium 2-[methyloleoylamino]ethane-1-sulphonate
Cas Number:
137-20-2
Molecular formula:
C21H40NO4S.Na
IUPAC Name:
Sodium 2-(methyloleoylamino)ethane-1-sulphonate
Test material form:
solid
Details on test material:
Name of the test chemical: Sodium 2-(methyloleoylamino)ethane-1-sulphonate
Molecular Formula: C21H40NO4S.Na
Molecular Weight: 425.606 g/mol
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: Sodium 2-(methyloleoylamino)ethane-1-sulphonate
Molecular Formula: C21H40NO4S.Na
Molecular Weight: 425.606 g/mol
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan spotted
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:RCC Ltd Laboratory Animals Services CH-4414 Fuillinsdorf/Switzerland
- Age at study initiation:5-7 weeks
- Weight at study initiation:328-422g
- Housing: Individually in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum):Pelleted standard Provimi Kliba 3418nos43/03 and 52/03 containing vitamins C ad libitum
- Water (e.g. ad libitum):Community tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±30C
- Humidity (%):30-70%
- Air changes (per hr):10-15 air changes /hr
- Photoperiod (hrs dark / hrs light):12hrlight/12hrdark

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: Polyethylene glycol 300(PEG300)
Concentration / amount:
50%
Day(s)/duration:
3 weeks
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Polyethylene glycol 300(PEG300)
Concentration / amount:
50%
Day(s)/duration:
6hr
No. of animals per dose:
Total :60
Treated group:20female
Control group:10 female
Positive Control group:20 male
Control group:10 male
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period: 6hr
- Test groups:20
- Control group:10
- Site: left shoulder(the fur was clipped from application site )
- Frequency of applications: one patch per week
- Duration: 3 weeks
- Concentrations: 50%in PEG300

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 2weeks after last induction

- Exposure period: 6hr

- Test groups:20
- Control group:10
- Site: The left posterior quadrant of the side and back of the animals

- Concentrations:50%in PEG 300
- Evaluation (hr after challenge): 24 and 48hr

Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
Alpha hexylcinnamaldehyde

Study design: in vivo (LLNA)

Statistics:
Descriptive statistics (means and standard deviations) were calculated for body weight. No inferential statistics were used.

Results and discussion

Positive control results:
Positive control produced discrete/patchy to moderate /confluent erythema in twenty (at 24hr reading) and nineteen (at the 48hr reading) out of 20 test animals. No skin effect was observed in the control group.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin sensitization effects were observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin sensitization reaction was obsrved
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not Sensitizing
Conclusions:
The Sodium 2-(methyloleoylamino)ethane-1-sulphonate (137-20-2)was considered to be not skin sensitizing in guinea pig .

Executive summary:

The skin sensitization study of Sodium 2-(methyloleoylamino) ethane-1-sulphonate(137-20-2)was performed by Buhler test in 20 female Ibrn:GOHI; SPF(Himalayan spotted)guinea pigs.An additional 20 male animals in a positive control group. Alpha hexylcinnamaldehyde served as positive control and 10 female and 10 male in control group. Food and water provided libitum to all animals. The test item and vehicle were placed in to a glass beaker and weight/weight dilutions were prepared. The preparations were made immediately prior to each dosing.

 In induction phase, Total 3 inductions as one per week for three weeks were given using 50% concentration in PEG 300 using patch on left shoulder. The guinea pigs fur was shaved with a fine clipper blade just before exposure and closed patches were applied as 0.5 ml of the freshly prepared test item solution was placed in 25mm Hill Top Chamber. The Hill Top Chamber was firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with an impervious adhesive tape. The occlusive dressing was left in place for 6 hr. The site was evaluated after 24 hr for any skin reaction. In challenge phase, test substance 50% concentration in same vehicle given as challenge dose2 weeks after last induction i.e on day 29.The site observed after 24 and 48hr post challenge dose. Responses were evaluated for two parameter as incidence index and severity index. No skin sensitizing reaction observed after challenge application so, in this study the incidence index and severity index were zero. No mortality was observed, hence no necropsies were performed. No symptoms of systemic toxicity were observed in the animals. The body weight of the animals was the range commonly recorded for animals of this strain and age.

 Positive control produced discrete/patchy to moderate /confluent erythema in twenty (at 24hr reading) and nineteen (at the 48hr reading) out of 20 test animals. No skin effect was observed in the control group. Hence Sodium 2-(methyloleoylamino) ethane-1-sulphonate(137-20-2)was considered to be not skin sensitizing in guinea pig

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