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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 B4 of directive 92/69/EEC and OECD 404
GLP compliance:
yes

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped free
Vehicle:
other: none
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3
Details on study design:
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5ml of the test material was introduced under 2.5cmx 2.5cm cotton gauze pad and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. 4-hours after application the patches were removed and residual test material removed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
no data
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
No sign of dermal irritation observed, and thus classified as Non-Irritant
Executive summary:
Robust summary is attached