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EC number: 421-450-8 | CAS number: 154702-15-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1995
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- Bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl)anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate
- Details on test material:
- - Name of test material (as cited in study report): RA 3643
- Physical state: white powder
- Lot/batch No.: 51/95
- Storage condition of test material: ambient and in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF-bred albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 2-3 weeks (ordered)
- Housing: in a mobile battery containing 4 cages; one cage per group of at most 10 animals
- Diet (e.g. ad libitum): pelleted, natural ingredient diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 58-85%
- Air changes (per hr): about 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark cycle
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1 ml for the intradermal injection
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1 ml for the intradermal injection
- No. of animals per dose:
- Preliminary testr: two sets of 3 animals
Main study: test group of 5 males and 5 females; control group of 3males and 3 females
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% dilution of test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no dermal reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% dilution of test item. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no dermal reaction.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- the test substance RA 3643 is considered not to be a sensitizer
- Executive summary:
The test substance RA 3643 was examined for possible sensitizing properties by a maximization test in guinea pigs using 10 test animals and 6 controls.
The test comprised:
TEST ANIMALS
- induction treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 diluted with isotonic saline, a 3% dilution of RA 3643 in maize oil, and a 3% dilution of RA 3643 in vaseline (test site pretreated with sodium lauryl sulfate),
- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,
CONTROLS
- induction treatment by intradermal injections of FCA 1:1 diluted with isotonic saline, maize oil, and FCA/saline 1:1 diluited with maize oil, followed one week later by topical application of patches loaded with vaseline (test sites pretreated with sodium lauryl sulfate), and
- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,
None of the test animals reacted positively. Therefore, the test substance RA 3643 is considered not to be a sensitizer. Since clear and unequivocal results were obtained in this study, no need for further examination in an additional batch of test and control animals is required.
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