Registration Dossier
Registration Dossier
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EC number: - | CAS number: 1474044-66-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 April - 10 May 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was already available
Test material
- Reference substance name:
- Sodium octane-1-sulphonate monohydrate
- EC Number:
- 226-195-4
- EC Name:
- Sodium octane-1-sulphonate monohydrate
- Cas Number:
- 5324-84-5
- Molecular formula:
- C8H18O3S.Na
- IUPAC Name:
- sodium octane-1-sulfonate hydrate
- Test material form:
- other: aqueous solution
- Details on test material:
- - Name of test material (as cited in study report): Bio-terge PAS-8S
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc.
- Age at study initiation:no data
- Weight at study initiation: 225-325 g
- Housing: singly in wire mesh suspensioncages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr): 12 h/12 h
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- induction: 25 %w/v of test substance
Challenge: 5 % w/v of test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- induction: 25 %w/v of test substance
Challenge: 5 % w/v of test substance
- No. of animals per dose:
- 10 male/10 female
- Details on study design:
- RANGE FINDING TESTS:
Test substance applied at 100 %, 50 %, 25 %, 10 %, 5 %, 2.5 % or 1 % w/v in distilled water. 4 concentrations/ guinea pig. 0.3 mL/patch. Occluded conditions. Based on the results, a concentration of 25 %w/v was chosen for induction and 5 %w/v for primary challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 0.3 mL of 25 %w/v solution
- Control group: none
- Site: upper left quadrant of backs
- Frequency of applications: weekly
- Duration: 6 hours under occlusive conditions
- Concentrations: 25 %w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:2 weeks after last induction
- Exposure period: 6 hours
- Test groups: 0.3 mL of 5 %w/v solution
- Control group: 0.3 mL of 5 %w/v solution
- Site: lower left quadrant of backs
- Concentrations: 5 %w/v solution
- Evaluation (hr after challenge): 24 & 48 h
OTHER: - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Mean severity of skin scores = 0.0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %wv/v
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- Mean severity of skin scores = 0.03
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %w/v
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Mean severity of skin scores= 0.2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %w/v
- No. with + reactions:
- 5
- Total no. in group:
- 19
- Clinical observations:
- Mean severity of skin scores = 0.1
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
One animal in the test group was found dead after the third induction. Necrospy showed lungs pale, liver pale, abdominal cavity filled witha red blood-like material and slight post mortem autolysis.
The incidence and severity of the responses in the test group was essentially comparable to that produced by the naive control group, indicating that sensitisation had not been induced.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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