Registration Dossier
Registration Dossier
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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
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: information provided by ECHA
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines 406 EEC B.6 method, Section 4.1.7, Maximization test according to Magnusson and Kligman
- GLP compliance:
- yes
- Type of study:
- other: maximization test
- Justification for non-LLNA method:
- not specified.
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- 2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
Constituent 1
In vivo test system
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 6 - Details on study design:
- Concentration of test material and vehicle used at induction:
Since an irritating concentration could not be obtained during the preliminary stage, it was decided to pretreat the induction test site with 10% SODIUM LAURYL SULFATE solution in vaseline.
The following concentrations of test material were used at induction: (1st phase INTRADERMAL INJECTIONS)
1) FCA (Freund's complete adjuvant) 1:1 diluted with isotonic saline
2) test material in maize oil (3% dilution)
3) 3% dilution of test material in maize oil and FCA/Saline 1:1
4) After 1 week topical application of 30% test material in vaseline
Concentration of test material and vehicle used for each challenge:
Challenge treatment (14 days after induction) by topica application of a 30% dilution of test material in vaseline and of vaseline alone.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 30 %
Signs of irritation during induction:
The topical pretreatment with sodium lauryl sulphate induced slight erythema in the controls and test animals. After the 48-hour topical application of the patches loaded with vaseline only, slight signs of skin irritation were observed in the controls. In the test animals also sligth signs of skin irritation were observed after the 48-hour topical application of the 30% dilution test substance.
Evidence of sensitisation of each challenge concentration:
Neither at 24 hours nor at 48 hours after the challenge treatment did the 30% test dilution in vaseline or vaseline alone induced skin reactions in test animals and controls.
Other observations:
None of the test animals reacted positively. Therefore the test substance in considered NOT to be a SENSITIZER. Since clear and unequivocal results were obtained in this study, no need for further examination in an addional batch of test
and control animals in required.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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