Registration Dossier
Registration Dossier
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EC number: 811-484-5 | CAS number: 680972-33-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: Read across from category (Hydrotropes)
- Adequacy of study:
- key study
- Study period:
- 1983-06-01 To 1983-07-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: As per OECD guidelines 406.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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:
- Method valid OECD 406
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Valid skin sensitization methiod.
Test material
- Reference substance name:
- Sodium cumenesulphonate
- EC Number:
- 248-983-7
- EC Name:
- Sodium cumenesulphonate
- Cas Number:
- 28348-53-0
- Molecular formula:
- C9H12O3S.Na
- IUPAC Name:
- sodium 2-phenylpropane-2-sulfonate
- 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
Constituent 1
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 days
ENVIRONMENTAL 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)
Induction
- 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.
Challenge
- 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 STUDY
A. 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
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 21
- Group:
- test chemical
- 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 chemical
- 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.
- Reading:
- other: Positive control
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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.
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