Registration Dossier
Registration Dossier
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EC number: 425-220-8 | CAS number: 5945-33-5
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: GLP study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Method B6 of 92/69/EEC or OECD 406
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 425-220-8
- EC Name:
- -
- Cas Number:
- 5945-33-5
- Molecular formula:
- C39H34O8P2
- IUPAC Name:
- 4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenyl diphenyl phosphate; 4-{2-[4-({[4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenoxy](phenoxy)phosphoryl}oxy)phenyl]propan-2-yl}phenyl diphenyl phosphate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal induction: Arachis oil, Freund's Complet Adjuvant 1:1; Topical induction and challenge - Arachis oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal induction: Intradermal induction - 5% in arachis oil BP; topical induction - 75% in arachis oil BP; Topical challenge - 75 and 50% in arachis oil BP
Freund's complete Adjuvant (FCA) in distilled water (1:1)
5% w/v formulation of test material in arachis oil
5% w/v formulation of test material in 1:1 preparation of
FCA in distilled water.
Topical induction:
75% w/v in arachis oil
Concentration of test material and vehicle used for each challenge:
50% and 75% w/v in arachis oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal induction: Arachis oil, Freund's Complet Adjuvant 1:1; Topical induction and challenge - Arachis oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal induction: Intradermal induction - 5% in arachis oil BP; topical induction - 75% in arachis oil BP; Topical challenge - 75 and 50% in arachis oil BP
Freund's complete Adjuvant (FCA) in distilled water (1:1)
5% w/v formulation of test material in arachis oil
5% w/v formulation of test material in 1:1 preparation of
FCA in distilled water.
Topical induction:
75% w/v in arachis oil
Concentration of test material and vehicle used for each challenge:
50% and 75% w/v in arachis oil
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - 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:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 75 %
Signs of irritation during induction:
Very slight(3 animals) to moderate to severe erythema (7
animals) was noted after the intradermal induction at the 24
hour reading, and very slight to severe erythema after 48
hours.
After topical induction, very slight erythema was observed
in all test animals and very slight oedema was noted in 4
test group animals at the 1-hour reading. No dermal
reactions were noted after 24 hours.
Evidence of sensitisation of each challenge concentration:
No sensitisation observed
Other observations:
One test group animal was killed for humane reasons on day
16. Its absence was not considered to affect the purpose or
integrity of the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information not classified
- Conclusions:
- No sensitization was observed, and as such classified as a NON Sensitizer
- Executive summary:
Find a robust summary in the endpoint summary record field
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