Registration Dossier
Registration Dossier
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EC number: 600-709-0 | CAS number: 106006-84-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January/ February 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson and Kligman
- Deviations:
- not specified
- Principles of method if other than guideline:
- Study according to Magnusson and Kligman´s "Guinea Pig Maxiximization Test"
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- checked
- IUPAC Name:
- checked
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: different vehicles used
- Concentration / amount:
- 1.0 % up to 25 % depending on application
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: different vehicles used
- Concentration / amount:
- 1.0 % up to 25 % depending on application
- No. of animals per dose:
- 20 f , 10 f als control grpup
- Challenge controls:
- on 22nd day after dermal application, 25 % in ethnol
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 ml 25 % suspension for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 ml 25 % suspension for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.3 ml 25 % suspension for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.3 ml 25 % suspension for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.3 ml 25 % suspension for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: no LLNA was performed, so not applicable.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- In the sensitization test based on Magnusson and Kligman´s "Guinea Pig Maximization Test", the substance SND 919 Propionylthiazol did not induce aany allergic reaction by skin contact in any of the 20 guinea pigs treated.
Thus the substnace SND 919 Propionylthiazol revealed no sensitizing potential under the stated study conditions. - Executive summary:
A skin sensitozation study with the substance SND 919 Propionylthiazol was carried out in guinea pigs.
The test animals were sensitized in two stages. On day 22 of the study an attempt was made to challenge an allergic contact dermatitis.
After the challenge exposure no allergic contact dermatitis was registered in the guinea pigs treated with SND 929 Propionylthiazol.
So under the stated study conditions the substance SND 919 Propionylthiazol revealed no sensitizing potential.
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