Registration Dossier
Registration Dossier
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EC number: 415-670-3 | CAS number: 78850-37-0 GR138766X
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
- GLP compliance:
- yes
In vivo test system
Test animals
- Species:
- other: Albino guinea pigs
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradmal induction - 5%w/v in achachis oil
- 5% w/v in a mixture of freund's
complete adjuvant plus arachis oil
Topical induction - 50% w/w in arachis oil
Concentration of test material and vehicle used for each challenge:
50 and 25% in arachis oil.
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradmal induction - 5%w/v in achachis oil
- 5% w/v in a mixture of freund's
complete adjuvant plus arachis oil
Topical induction - 50% w/w in arachis oil
Concentration of test material and vehicle used for each challenge:
50 and 25% in arachis oil.
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 5 %
Signs of irritation during induction:
Topical induction - 5,10,25 and 50% gave a score of 1
(scattered mild redness) at the one hour reading and 50%
also gave a score of 1 at the 24 hour reading.
50% topical challenge gave a score of 1 at one hour.
Evidence of sensitisation of each challenge concentration:
2/20 animals showed evidence of sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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