Registration Dossier
Registration Dossier
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EC number: 411-080-5 | 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: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
- Principles of method if other than guideline:
- The test substance Pigment Yellow 26290 was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on female guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 2.5 %
Topical induction: 25 %
Challenge: 25 %
The test concentrations were determined in a dose finding assay. An intracutan injection of a 0 - 2.5% solution revealed no effect, whereas with a 5% solution wheals were obvious. With a topical induction and a challenge with a 25% solution no erythema and no edema were evident after 48 and 72 hours. - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- content: 83.9%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor: DHPW
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal induction: 2.5 %
Topical induction: 25 %
Challenge: 25 %
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal induction: 2.5 %
Topical induction: 25 %
Challenge: 25 %
- No. of animals per dose:
- 3 goups of experimental animals were randomly established for the main test:
one test substance group consisting of 20 animals (no 21 to 40) and 2 control groups consisting of 10 animals each (no 1 to 10, and 11 to 20)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%, 6%, 12%, 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%, 6%, 12%, 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: reddening + edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3%, 6%, 12%, 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3%, 6%, 12%, 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: reddening + edema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- reddening+edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: reddening+edema.
Any other information on results incl. tables
Neither the test substance animals nor the control animals showed any skin reddening after challenge exposure to the 25% test compound formulation. The test compound was formulated in physiological saline solution (sterile) as a suspension.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
The test substance Pigment Yellow 26290 was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on female guinea pigs.
Neither the test substance animals nor the control animals showed any skin reddening after challenge exposure to the 25% test compound formulation. The test compound was formulated in physiological saline solution (sterile) as a suspension.
Under the conditions of the maximisation test, the test compound has no skin sensitizing potential.
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