Reaction products of tetrabromophthalic anhydride with 2,2'-oxydiethanol and methyloxirane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performred in 1978 prior to adoption of GLPs and international guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Principles of method if other than guideline:

Hair clipped from back of 3M/3F rabbits. Skin abraded in 3 rabits. 0.5 ml test material applied to the skin under a 1 inch gauze patch, ocered with bandaging and wrapped with plastic wrap adn tape. Collars applied. Removed after 24 hr exposures. Examined immediately and 48 adn 72 hours later.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate

EC Number:

243-885-0

EC Name:

2-(2-hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate

Cas Number:

20566-35-2

Molecular formula:

C15H15Br4O7 (one ring component) C8 H2 Br4 O4 . C4 H10 O3 . C3 H8 O2 Unspecified reaction product of the three components

IUPAC Name:

2-(2-hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate

Details on test material:

FM PHT-4Diol was the test article. Supplied by Velsicol Chemical Corporation, Chicago, IL.

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml/rabbit

Duration of treatment / exposure:

24 hr

Observation period:

Through 72 hrs

Number of animals:

3 Males, 3 Females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

Draize

Score:

0.7

Max. score:

1

Remarks on result:

other: includes animals with abraded skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible within: 0

Remarks:

min

Remarks on result:

no indication of irritation

Remarks:

non abraded skin results only

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible within: 0

Remarks:

min

Remarks on result:

no indication of irritation

Remarks:

animals with non abraded skin only

Any other information on results incl. tables

The backs of three male and female New Zealand albino rabbits were clipped. The skin of three were abraded. A single application of TBPA Diol (0.5 ml) was made to the back of each rabbit under a gauze patch and wrapped with an airtight occlusive wrap. The skin was examined at 24, 48 and 72 hours post-dosing. No irritation was noted on the intact skin. Erythema and edema were observed on the abraded skin. The primary irritation index, according to the method of Draize, was 0.7. TBPA Diol was not a primary skinirritant under the conditions of this test.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The backs of three male and female New Zealand albino rabbits were clipped. The skin of three were abraded. A single application of TBPA Diol (0.5 ml) was made to the back of each rabbit under a gauze patch and wrapped with an airtight occlusive wrap. The skin was examined at 24, 48 and 72 hours post-dosing. No irritation was noted on the intact skin. Erythema and edema were observed on the abraded skin. The primary irritation index, according to the method of Draize, was 0.7. TBPA Diol was not a primary skinirritant under the conditions of this test.

Executive summary:

The backs of three male and female New Zealand albino rabbits were clipped. The skin of three were abraded. A single application of TBPA Diol (0.5 ml) was made to the back of each rabbit under a gauze patch and wrapped with an airtight occlusive wrap. The skin was examined at 24, 48 and 72 hours post-dosing. No irritation was noted on the intact skin. Erythema and edema were observed on the abraded skin. The primary irritation index, according to the method of Draize, was 0.7. TBPA Diol was not a primary skinirritant under the conditions of this test.