Registration Dossier
Registration Dossier
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EC number: 202-551-4 | CAS number: 97-00-7
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: conforms to guideline of the time & GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study conducted in 1996, before publication of EC Regulation 2017/706 on skin sensitization
Test material
- Reference substance name:
- 1-chloro-2,4-dinitrobenzene
- EC Number:
- 202-551-4
- EC Name:
- 1-chloro-2,4-dinitrobenzene
- Cas Number:
- 97-00-7
- Molecular formula:
- C6H3ClN2O4
- IUPAC Name:
- 1-chloro-2,4-dinitrobenzene
- Details on test material:
- yellow powder
purity: 99,1 %
Stability in ethanol/water (vehicle): > 6h
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- Weigt range: 293 - 345g; mean: 313g
controlled climate: ca. 20 C, 50 % humidity
food & water : ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: induction: ethanol/water (4/1); challenge: acetone
- Concentration / amount:
- first & second induction;: 0,5 %
third induction: 0,1 %
challenge: 0,1 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: induction: ethanol/water (4/1); challenge: acetone
- Concentration / amount:
- first & second induction;: 0,5 %
third induction: 0,1 %
challenge: 0,1 %
- No. of animals per dose:
- Control: 10
Treatment: 20 - Positive control substance(s):
- not required
- Remarks:
- This was a positive cotrol test
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin yellow discolored
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin yellow discolored.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin yellow discolored
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin yellow discolored.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0,1 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- skin yellow discolored
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: skin yellow discolored.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0,1 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- skin yellow discolored
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,1 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: skin yellow discolored.
- Reading:
- other: not specified
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- 1-chloro-2,4-dinitrobenzene was sensitising in guinea pigs after treatemnt using the Buehler test method
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