Registration Dossier
Registration Dossier
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EC number: 413-060-1 | CAS number: 19186-97-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other: ECHA inquiry result
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 406
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 413-060-1
- EC Name:
- -
- Cas Number:
- 19186-97-1
- Molecular formula:
- C15H24O4PBr9
- IUPAC Name:
- tris[3-bromo-2,2-bis(bromomethyl)propyl] phosphate
Constituent 1
In vivo test system
Test animals
- Species:
- other: Hartley guinea pigs
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
neat test material (0.3g)
none
Concentration of test material and vehicle used for each challenge:
neat test material (0.3g)
none
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
neat test material (0.3g)
none
Concentration of test material and vehicle used for each challenge:
neat test material (0.3g)
none
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation during induction:
No irritation
Evidence of sensitisation of each challenge concentration:
0
Other observations:
All animals remained healthy troughout the study. No
irritation was noted on any animal at any time during the
study.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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