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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
: Post-study body weights of animals are not mentioned.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The in vivo study data were obtained in studies performed before any in vitro sensitization tests tests had been validated and accepted for regulatory purposes.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium cumene sulphonate ex Maccon (E-2237.01)- Molecular formula (if other than submission substance): C9-H12-O3-S.Na- Molecular weight (if other than submission substance): Not available- Substance type: Pure active substance- Physical state: Liquid- Analytical purity: See below- Impurities (identity and concentrations): See below- Composition of test material, percentage of components: See below- Isomers composition: See below- Purity test date: See below- Lot/batch No.: See below- Expiration date of the lot/batch: See below- Stability under test conditions: not available- Storage condition of test material: Room temperature in the dark- Other: See below

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Hacking and Churchill Ltd.- Age at study initiation: Young females- Weight at study initiation: 599-853 gm- Housing: Caged in groups of two by dose group in grid floor propylene cages.- Diet (e.g. ad libitum): Guinea Pig diet, standard with vitamin C, Special diets Srvices Ltd., Witham, ad libitum- Water (e.g. ad libitum): ad libitum (A certificate for quality of drinking water was issued by the Yorkshire Water Authority)- Acclimation period: at least 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18-26 deg C- Humidity (%): 40-64%- Air changes (per hr): Not available- Photoperiod (hrs dark / hrs light): 12/12 (artificial light, 06.00 to 18.00)IN-LIFE DATES: From: 1983-06-01 To: 1983-07-01

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
One group of 20 test animals was treated with 0.4 ml of undiluted test material for an exposure period of 6 hours weekly for 3 induction exposures. Both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test material.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
One group of 20 test animals was treated with 0.4 ml of undiluted test material for an exposure period of 6 hours weekly for 3 induction exposures. Both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test material.
No. of animals per dose:
Induction: group of 20 test animal treated with 0.4 ml of undiluted sodium cumene sulphonate.Range Finding test: 2 test animals were taken, for each of the following concentration- undiluted test material, 50%, 25% and 10% (v/v).Primary challenge: 10 control animals previously untreated were treated with undiluted test material.
Details on study design:
RANGE FINDING TESTS: 2 test animals were taken, for each of the following concentration- undiluted test material, 50%, 25% and 10% (v/v).MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 3- Exposure period: 6 hours- Test groups: 0.4 ml of undiluted sodium cumene sulphonate.- Control group: None- Site: Shaved left flank of each animal.- Frequency of applications: once a week for 3 weeks- Duration: 6 hours, test substance was applied to the lint pads and were held in place with an overlapping impermeable occlusive tape and secured by elastic adhesive bandage.- Concentrations: undiluted sodium cumene sulphonate.B. CHALLENGE EXPOSURE- No. of exposures: One 6 hour exposure - Day(s) of challenge: 2 weeks after the last induction exposure- Exposure period: 6 hours under occlusion- Test groups: 0.4 ml of undiluted sodium cumene sulphonate.- Control group: 0.4 ml of undiluted sodium cumene sulphonate.- Site: freshly clipped Right flank that has not been treated before. - Concentrations: undiluted sodium cumene sulphonate.- Evaluation (hr after challenge): 21 and 45 hours after challenge exposure OTHER: None
Challenge controls:
10 control animals (previously unexposed) treated with 0.4 ml of undiluted sodium cumene sulphonate.
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
Not applicable

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
21
Group:
test group
Dose level:
0.4 ml of undiluted sodium cumene sulphonate
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 21.0. Group: test group. Dose level: 0.4 ml of undiluted sodium cumene sulphonate. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No response.
Reading:
1st reading
Hours after challenge:
21
Group:
negative control
Dose level:
0.4 ml of undiluted sodium cumene sulphonate.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 21.0. Group: negative control. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No response.
Reading:
2nd reading
Hours after challenge:
45
Group:
test group
Dose level:
0.4 ml of undiluted sodium cumene sulphonate.
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 45.0. Group: test group. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No response.
Reading:
2nd reading
Hours after challenge:
45
Group:
negative control
Dose level:
0.4 ml of undiluted sodium cumene sulphonate.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 45.0. Group: negative control. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No response.

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Thus, undiluted sodium cumene sulphonate is not a skin sensitizer in guinea pigs.
Executive summary:

The sensitization potential of sodium cumene sulfonate was assessed in a study where one group of 20 test animals was treated with 0.4 ml of undiluted sodium cumene sulphonate for an exposure period of once weekly to 6 hours induction exposures for 3 weeks. After a 2 week rest period, both test (20) and control (10) animals were challenged with 0.4 ml of undiluted sodium cumene sulphonate.

On challenge with 0.4 ml of undiluted sodium cumene sulphonate, no reaction was observed in any of the test animals and conrtrol animals at both the 21 -hour and 45 -hour reading. No evidence for sensitization was observed in this study.