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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
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
Draize
Score:
0.7
Max. score:
1
Remarks on result:
other: includes animals with abraded skin
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
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.