Dibenzo[d,f][1,3,2]dioxaphosphepin, 6,6'-[[3,3',5,5'-tetrakis(1,1-dimethylethyl)[1,1'-biphenyl]-2,2'-diyl]bis(oxy)]bis-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occluded exposure

Principles of method if other than guideline:

The animals were maintained on appropriate commercial diet and municipal water. Both are available ad libitum except during periods of fasting or manipulation. Male or female New Zealand White Rabbits are dosed with 0.5 ml (or 0.5 g for solids, moistened with water or other suitable vehicle). The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml (or 0.5 g) is lethal. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period. Excess sample is removed after contact. Skin reaction is scored by the Draize method at one hour, one day, 2 days, 3 days, 7 days, and, depending on the local skin reaction, possibly 10 and 14 days after dosing.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-400-9

EC Name:

-

Cas Number:

138776-88-2

Molecular formula:

C52H56O6P2

IUPAC Name:

9-[(3,3',5,5'-tetra-tert-butyl-2'-{8,10-dioxa-9-phosphatricyclo[9.4.0.0²,⁷]pentadeca-1(11),2(7),3,5,12,14-hexaen-9-yloxy}-[1,1'-biphenyl]-2-yl)oxy]-8,10-dioxa-9-phosphatricyclo[9.4.0.0²,⁷]pentadeca-1(11),2,4,6,12,14-hexaene

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

other: moistened with corn oil

Controls:

not required

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

6 (3 male, 3 female)

Details on study design:

Male or female New Zealand White rabbits are dosed with 0.5 ml (or 0.5 g for solids, moistened with water or other suitable vehicle). The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml (or 0.5 g) is lethal. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period. Excess sample is removed after contact. Skin reaction is scored, by the method of Draize (given below), at one hour, one day, 2 days, 3 days, 7 days, and, depending on the local skin reaction, possibly 10 and 14 days after dosing.

Scoring was conducted accroding to the method of Draize.
DRAIZE SCORING SYSTEM FOR SKIN IRRITATION
Evaluation of skin reactions:
Erythema and eschar formation:
No erythema-------------------------------- 0
Very slight erythema (barely perceptible)---------------------- 1
Well-defined erythema------------------------------------------ 2
Moderate to severe erythema------------------------------------ 3
Severe erythema (beet redness) to slight eschar formation (injury in depth)----------------------------------------- 4

Edema formation:
No edema------------------------------------------------------- 0
Very slight edema (barely perceptible)------------------------- 1
Slight edema (edges of area well defined by definite raising)--------------------------------- 2
Moderate edema-(raised approximately 1 millimeter)------------- 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure)------------------------------ 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

See Skin Irritation Data in Attachments for details on results.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A 4-hour application to covered male and female rabbit skin resulted in no irritation throughout the 7 day observation period.

Executive summary:

A 4 -hour application of 0.5g of the substance (moistened with corn oil) to occluded rabbit skin resulted in no erythema, edema or other reaction on any of 6 animals. All dosed sited remained unaffected throughout the 7 day observation period.