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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28th September 2012 to 6th December 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA was considered not to be suitable for the test substance.

Test material

Constituent 1
Reference substance name:
Sulfonic acids, C16-18-alkane hydroxy and C16-18-alkene, sodium salts
EC Number:
294-430-8
EC Name:
Sulfonic acids, C16-18-alkane hydroxy and C16-18-alkene, sodium salts
Cas Number:
91722-28-0
IUPAC Name:
Sulfonic acids, C16-18-alkane hydroxy and C16-18-alkene, sodium salts
Test material form:
liquid
Details on test material:
Identification: Internal Olefin Sulfonate
Description: pale yellow liquid
Storage conditions: approximately 4°C in the dark
The test item was heated to approximately 30°C and homogenized prior to use.
Specific details on test material used for the study:
Expiry/retest date: 31 December 2012

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Slc: Hartley, closed colony, SPF
- Age at study initiation: 5 Weeks old
- Weight at study initiation: 301–328 g
- Housing: The animals were housed 5 or 6 per cage during the quarantine and acclimatization period, and 5 per cage during the experimental period.
- Diet: Pellet diet RC4 was offered ad libitum.
- Water: Municipal tap water filtered through a 5 -μm cartridge filter was offered ad libitum through an automatic water-supply system.
- Acclimation period: For 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9–24.6
- Humidity (%): 45.8%–64.1
- Air changes (per hr): 12 Times /hour
- Photoperiod (hrs dark / hrs light): 12 Hours/day (on at 6:00 AM, off at 6:00 PM)

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
For intradermal sensitization: 0.05 w/w%
For contact sensitization: 0.5 w/w%
Day(s)/duration:
For contact sensitization: 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For challenge: 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 animals in the test-substance sensitization group
5 animals in the control group
Details on study design:
RANGE FINDING TESTS: In the preliminary study conducted under non-GLP conditions (study No. 1217-[1]), the test-substance solutions at 10, 5, 3, 1, 0.5, 0.3, 0.1, 0.05, 0.03, 0.01, 0.005, and 0.003 w/w% were intradermally administered. As a result, the solutions at 10, 5, 3, 1, 0.5, and 0.3 w/w% induced necrosis; the solution at 0.1w/w% induced subtle erythema to erythema with edema; and the solution at 0.05 w/w% induced subtle erythema. After occlusive application of the test-substance solutions at 5, 3, 1, 0.5, 0.3, and 0.1 w/w%, the solutions at 5 and 3 w/w% induced erythema of Score 4 (Score 4 means eschar) with edema of Scores 2 or 3; the solution at 1 w/w% induced erythema of Scores 1 through 4 (Score 4 means eschar) with edema of Score 1; and the solution at 0.5w/w% solution induced erythema of Score 1. Based on the above results, 0.05 w/w% was selected for intradermal sensitization; 0.5 w/w%, for contact sensitization; and 6 concentrations of 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%, for challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
For intradermal sensitization of the test-substance group, 0.1 mL each of the following 3 test materials were intradermally injected into 2 sites of the cervical region of the guinea pigs:
A, an emulsion of equal volumes of Freund’s complete adjuvant (FCA) and physiological saline;
B, the test-substance solution at 0.05w/w% (vehicle: physiological saline);
C, an emulsion of equal volumes of the test-substance solution at 0.1 w/w% (vehicle: physiological saline) and FCA.
For contact sensitization, 0.2 mL of the test-substance solution at 0.5 w/w% (vehicle: water for injection) was impregnated into a 2×4-cm piece of lint cloth on the day 7, followed by occlusive application to the sites for intradermal injection for 48 hours.
The control animals were treated in the same manner with the vehicles for each sensitization.

B. CHALLENGE EXPOSURE
For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w% (vehicle: water for injection) was impregnated into 1.5×1.5-cm pieces of lint cloth on the day 21 of the sensitization, and 24-hour occlusive application was made on the right and left lateral region.
Observation of skin reaction was performed 24 and 48 hours after patch removal.
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the test substance has no skin-sensitization potential based on the above results.
Executive summary:

The skin sensitization potential of Internal Olefin Sulfonate was examined in guinea pigs according to the maximization test method. A total of 15 animals were used in the following groups: 10 animals in the test-substance sensitization group and 5 animals in the control group.


 


For intradermal sensitization of the test-substance group, 0.1 mL each of the following 3 test materials were intradermally injected into 2 sites of the cervical region of the guinea pigs: A, an emulsion of equal volumes of Freund's complete adjuvant (FCA) and physiological saline; B, the test-substance solution at 0.05w/w% (vehicle: physiological saline); C, an emulsion of equal volumes of the test-substance solution at 0.1 w/w% (vehicle: physiological saline) and FCA. For contact sensitization, 0.2 mL of the test-substance solution at 0.5 w/w% (vehicle: water for injection) was impregnated into a 2×4-cm piece of lint cloth on the day 7, followed by occlusive application to the sites for intradermal injection for 48 hours. The control animals were treated in the same manner with the vehicles for each sensitization. For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w% (vehicle: water for injection) was impregnated into 1.5×1.5-cm pieces of lint cloth on the day 21 of the sensitization, and 24-hour occlusive application was made on the right and left lateral region. Observation of skin reaction was performed 24 and 48 hours after patch removal.


 


As a result, no skin reaction was noted at any test concentration in either of thetest-substance sensitization group or control group. During the observation period, no abnormalities were found in the general condition of the animals, and weight gain was satisfactory. In conclusion, the test substance has no skin-sensitization potential based on the above results.