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Toxicological information

Skin sensitisation

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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:
1997

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

Constituent 1
Chemical structure
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

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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