Registration Dossier
Registration Dossier
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EC number: 432-090-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 92/69/EEC, B6 (Magnusson and Kligman maximisation test).
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: guinea pig, albino Dunkin-Hartley
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a)Intradermal Induction: 5% (w/v) in arachis oil BP
5% (w/v) in Freund's Complete
Adjuvant plus distilled water in the ratio 1:1.
b)Topical Induction: 50% (w/w) in arachis oil BP.
Concentration of test material and vehicle used for each challenge:
a) 50% (w/w) in arachis oil BP
b) 25% (w/w) in arachis oil BP
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a)Intradermal Induction: 5% (w/v) in arachis oil BP
5% (w/v) in Freund's Complete
Adjuvant plus distilled water in the ratio 1:1.
b)Topical Induction: 50% (w/w) in arachis oil BP.
Concentration of test material and vehicle used for each challenge:
a) 50% (w/w) in arachis oil BP
b) 25% (w/w) in arachis oil BP
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Signs of irritation during induction:
Intradermal Induction:
Grade 1-2 erythema was noted at the intradermal induction
sites of all test group animals 24 and 48 hours after
dosing. Grade 1 erythema was noted at the intradermal
induction sites of three control group aniamls 24 and 48
hours after dosing.
Topical Induction:
Yellow/brown-coloured staining of the skin was noted at the
topical induction sites of all test group animals but did
not affect the evaluation of erythema and oedema.
Grade 2-3 erythema and Grade 2 oedema were noted at the
topical induction sites of all test group animals one hour
after dressing removal. Grade 2 erythema and oedema were
noted at the induction sites of four test group animals 24
hours after dressing removal. Other adverse reactions noted
were bleeding from the intradermal injection site, dried
blood and small superficial scabs. A hardened dark
brown/black-coloured scab, preventing accurate evaluation of
erythema and oedema, was noted in six test group animals 24
hours after dressing removal.
Grade 1 erythema was noted at the topical induction sites of
four control group animals one hour after dressing removal
persisting in two animals 24 hours after dressing removal.
Other adverse reactions noted were bleeding from the
intradermal injection site and dried blood.
Evidence of sensitisation of each challenge concentration:
Number of animals showing evidence of sensitisation at each
challenge concentration: 10/10.
50% w/w in Arachis Oil BP:
Positive skin responses (Grades 1-2 erythema and oedema)
were noted at the challenge sites of all test group animals
24 and 48 hours after dressing removal. Other adverse
reactions noted were desquamation and small superficial
scattered scabs. No skin reactions were noted at the
challenge sites of control group animals.
25% w/w in Arachis oil BP:
Positive skin responses (Grades 1-2 erythema and oedema)
were noted at the challenge sites of all test group animals
24 and 48 hours after dressing removal. Other adverse
reactions noted were desquamation and small superficial
scabs. No skin reactions were noted at the challenge sites
of control group animals.
Other observations:
Bodyweight gains of animals in the test group, between day 0
and day 24, were comparable to those in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
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