2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt

Skin irritation / corrosion

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: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt

EC Number:

286-344-4

EC Name:

2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt

Cas Number:

85209-91-2

Molecular formula:

C29H43O4P.Na

IUPAC Name:

sodium 5,7,13,15-tetra-tert-butyl-10-oxo-9,11-dioxa-10λ⁵-phosphatricyclo[10.4.0.0³,⁸]hexadeca-1(12),3,5,7,13,15-hexaen-10-olate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Adult albino rabbits, Hra:(NZW)SPF
- Source:Hazleton Research Products, Inc., Denver PA
- Weight at study initiation: 2032 - 2116 g
- Housing: individually in screen-bottom cages,
- husbandry and housing: addording to "Guide for the Care and Use of Laboratory Animals" (NIH Publication No. 86-23 (revised 1985)).
- Diet (e.g. ad libitum): measured, High Fiber Rabbit Chow® 5326, Purina Mills, Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Temperature (°C): 18.9-23.3
- Humidity (%):48 to 55

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0,5 g test material (moistened with 0,9% saline)

VEHICLE
- Concentration (if solution): 0,9% saline

Duration of treatment / exposure:

4 hours

Observation period:

30 minutes = 4 hours; 24, 48, and 72 hours after patch removal

Number of animals:

6 (3 male, 3 female)

Details on study design:

TEST SITE
- Area of exposure: 2,5 cm x 2,5 cm
- Type of wrap if used: gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® and secured with Elastoplast® tape to provide a
semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM:according to the Draize technique (Draize, J.H. 1975)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

over 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

over 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

no erythema, no edema observed

Applicant's summary and conclusion

Interpretation of results:

other: not irritant