Registration Dossier
Registration Dossier
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EC number: 442-110-5 | 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: Annex V (maximisation)
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: Albino Guinea Pig (Dunkin Hartley strain)
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
A) 1:1 (w/w) mixture of Freund's Complete Adjuvant with
water for injection.
B) 0.2% test substance in propylene glycol
C) 1:1 (w/w) mixture of the test substance and of Freund's
Complete Adjuvant.
Concentration of test material and vehicle used for each challenge:
50% test substance and propylene glycol, using patch test
plasters.
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
A) 1:1 (w/w) mixture of Freund's Complete Adjuvant with
water for injection.
B) 0.2% test substance in propylene glycol
C) 1:1 (w/w) mixture of the test substance and of Freund's
Complete Adjuvant.
Concentration of test material and vehicle used for each challenge:
50% test substance and propylene glycol, using patch test
plasters.
- 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:
- 1
- 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: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 1
- 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: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: .2 %
Signs of irritation during induction:
The dermal reactions caused by the intradermal injections
were assessed for irritation. Necrosis was seen at the
injection sites. This was considered to be caused by the
vehicle rather than by the test substance.
No signs of irritation were observed up to the highest
epidermally tested concentration. Therefore, a 10% SDS
solution was applied to provoke a mild inflammatory
reaction.
Evidence of sensitisation of each challenge concentration:
At 50% test substance concentration, 7 out of 10 animals
showed a response indicative of sensitisation. No skin
reactions were evident in the control animals. These
results indicate a sensitisation rate of 70 per cent.
Other observations:
Yellow staining was observed at the test substance treated
skin sites, 24 and 48 hours after challenge. This staining
did not hamper scoring.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
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