Registration Dossier
Registration Dossier
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EC number: 460-380-2 | CAS number: -
Skin sensitisation
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:
- other: OECD/EU Guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The present guinea pig maximisation test is availabel and was conducted before requirements for LLNA applied.
As the study is reliable and applicable, it is considered that no further testing (LLNA) is needed.
Test material
- Reference substance name:
- SALACOS HCISV-L
- IUPAC Name:
- SALACOS HCISV-L
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report): SALACOS HCISV-L
- Substance type: organic, UVCB
- Physical state: solid
- Analytical purity: 100 %
- Impurities (identity and concentrations): not by definition of UVCB
- Purity test date:
- Lot/batch No.: 40314
- Expiration date of the lot/batch: 02-MAY-2003
- Stability under test conditions: stable in PEG 300 and in a 1:1 (v/v) mixture of FCA/physiological saline for at least 2 hours at room temperature (determined at RCC Ltd, Environmental Chemistry & Pharmanalytics Division, under the RCC Study Number 844539)
- Storage condition of test material: In the original container at room temperature, away from direct sunlight
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI, synonym: Himalayan spotted
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrassse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: 398 - 433 g
- Housing: individually
- Diet (e.g. ad libitum): pelleted standard provimi kliba 3418, buinea pig breeding / maintenance diet, containing Vitamin C, ad libitum
- Water (e.g. ad libitum): community tab water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Intredermal injections: 100 % Test item in vehicle
Epidermal Application: 100 % Test item in vehicle
Challange Application: 1 % Test item in vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Intredermal injections: 100 % Test item in vehicle
Epidermal Application: 100 % Test item in vehicle
Challange Application: 1 % Test item in vehicle
- No. of animals per dose:
- not applicable
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal: day 1 - 7, Epidermal: day 8 - 26
- Test groups: all
- Control groups: all
- Site: scapular region (appr. 6*8 cm2)
- Frequency of applications: once
- Duration: epidermal exposure: 48 hours
- Concentrations: see respective entry
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27
- Exposure period: 24 hours
- Test groups: all
- Control group: all
- Site: left and right flank (appr. 5*5 cm2)
- Concentrations: see respective entry, right flank: vehicle only
- Evaluation (hr after challenge): 24 and 48 hours after removal - Challenge controls:
- vehicle only
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- historical data (performed from 18-Feb-2002 to 02-April-2002): valid results
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % (w/w)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % (w/w)
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % in PEG300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs, SALACOS HCISV-L does not have to be treated
as a skin sensitizer. - Executive summary:
In order to assess the cutaneous allergenic potential of SALACOS HCISV-L, the Maximization-Test was performed in 15 (10 test and 5 control) male albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, 8.6. The intradermal induction of sensitization in the test group was performed in the nuchal region with the undiluted the test item and an emulsion of Freund's Complete Adjuvant (FCA) I physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undiluted test item one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion. Nineteen days after epidermal induction the control and test animals were challenged by epidermal application of the test item at 1 % in PEG 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
Results
Skin Reactions after the Challenge Procedure
after 24 hours
after 48 hours
positive / total
positive / total
CCONTROL GROUP
SALACOS HCISV-L, 1 % in PEG 300 (left flank)
0/5
0/5
PEG 300 only (right flank)
0/5
0/5
TEST GROUP
SALACOS HCISV-L, 1 % in PEG 300 (left flank)
0/10
0/10
PEG 300 only (right flank)
0/10
0/10
No toxic symptoms were evident in the guinea pigs of the control or test group.
No deaths occurred.
None of the control and test animals showed skin reactions after the challenge treatment with SALACOS HCISV-L at 1 % (w/w) in PEG 300.
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