Registration Dossier
Registration Dossier
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EC number: 415-430-8 | CAS number: 86403-32-9 CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (Magnusson a. Kligman)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white, Bor: DHPW(SPF)
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) 2,5 % intradermal in corn oil
b) 50 % in corn oil
Concentration of test material and vehicle used for each challenge
a) 25 %
Challengeopen allclose all
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) 2,5 % intradermal in corn oil
b) 50 % in corn oil
Concentration of test material and vehicle used for each challenge
a) 25 %
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 18.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Signs of irritation during induction: yes
Evidence of sensitisation of each challenge concentration: 20 animals
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
- Conclusions:
- Based on the positive results observed in animals induced intradermally, the substance was sensitising to the skin of guinea pigs
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