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EC number: 421-140-2 | 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: GLP study. Well described protocol and testing conditions. No deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: see "Comment" below- Guinea Pig Maximisation Test as per Magnusson and Kligmann Ref:"Allergic Contact Dermatitis in the Guinea Pig:Identification of contact allergens",Thomas ,C.C.Springfield ,Illinois,U.S.A.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Analytical purity: ca. 96%
- Composition of test material, percentage of components: contains 4% of moisture
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: ca. 4-5 weeks
- Weight at study initiation: 307 -341 g
- Housing: in groups of 5 in suspended metal cages with wire mesh floors
- Diet: ad libitum: vitamin C enriched guinea-pig diet FD2
- Water: ad libitum: drinking water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21.5°C
- Humidity (%): 40 - 65%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D (product based on cocnut oil, supplied by Alembic Products, Saltney, Chester, England)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal injection: 0.0 % Freunds adjuvant -diluted 50:50 with water
0.5 % w/v in water
0.5 % w/v in 50:50 Freunds adjuvant and water
Topical application: 60 % w/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
7.5% w/v (anterior site) and 5.0% w/v (posterior site) in Alembicol D
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D (product based on cocnut oil, supplied by Alembic Products, Saltney, Chester, England)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal injection: 0.0 % Freunds adjuvant -diluted 50:50 with water
0.5 % w/v in water
0.5 % w/v in 50:50 Freunds adjuvant and water
Topical application: 60 % w/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
7.5% w/v (anterior site) and 5.0% w/v (posterior site) in Alembicol D
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS: The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible: a) concentrations of the test substance that sould produce irritation suitable for the induction phase of the main study and b) a maximum non-irritant concentration by the topical route of administration for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Concentration Test groups: 1) 0.1 mL of Freund's complete adjuvant 50:50 with water for irrigation (Ph Eur); 2) 0.1 mL of RSS 4 dry substance, 0.5% w/v in Alembicol D; 3) 0.1 mL of RSS 4 dry substance, 0.5% w/v in Alembicol D in a 50:50 mixture of water for irrigation and Freund's complete adjuvant.
- Concentration Control group: 1) 0.1 mL of Freund's complete adjuvant 50:50 with water for irrigation (Ph Eur); 2) 0.1 mL of Alembicol D; 3) 0.1 mL of Alembicol D in Freund's complete adjuvant 50:50 with water for irrigation.
- Site: a 40x60 mm area of dorsal skin on the scapular region of the guinea-pig
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after induction
- Exposure period: 24 hours
- Concentrations Test groups: RSS 4 dry substance, 7.5% w/v and 5% w/v in Alembicol D.
- Concentrations Control group: RSS 4 dry substance, 7.5% w/v and 5% w/v in Alembicol D.
- Site: flanks of the guinea-pig
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (HCA), benzocaine, mercaptobenzothiazole (MBT)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 7.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 7.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 7.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 7.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 7.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 7.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Other observations:
One test animal was killed in extremis between the first and second inductions (Day 6).Necropsy revealed slightly
congested lungs and pale kidneys.
The death was considered to be incidental. No other signs of ill health or toxicity were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this study, RSS 4 dry substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the nine surviving test animals.
- Executive summary:
This study was performed to assess the skin sensitisation potential of RSS 4 dry substance using the guinea-pig.
This test was carried out in accordance with GLP standards and the study protocol followed was in accorance with internationally accepted methodologies.
Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:
Intradermal injection: 0.5% w/v in Alembicol D
Topical application: 60% w/v in Alembicol D
Challenge application: 7.5 and 5% w/v in Alembicol D
Ten test and five control guinea-pigs were used in this study.
In this study RSS4 dry substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the nine surviving test animals. One test animal was killed in extremis between the first and second inductions (Day 6), the animal was very thin with wet fur on the ventral surface. Necropsy revealed slightly congested lungs and pale kidneys. The death is considered to be incidental.
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