Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: BTP-3-3-055-81, Biological Corrosivity, (The Code of Federal Regulations, Title 49, Chapter 1, Section 173.1200, Appendix A).

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether

EC Number:

270-821-9

EC Name:

Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether

Cas Number:

68478-46-6

Molecular formula:

C14H23BF3NO2

IUPAC Name:

1-phenylmethanamine; 7-[(benzylamino)methyl]-10-(butoxymethyl)-5,8,11,15-tetraoxaicosan-13-ol; benzyl(3-butoxy-2-hydroxypropyl)amine; benzyl[3-butoxy-2-(3-butoxy-2-hydroxypropoxy)propyl]amine; dibenzyl(3-butoxy-2-hydroxypropyl)amine

Test material form:

liquid: viscous

Details on test material:

One (1) bottle of Curing Agent #Ancamine 1040 (approx. 500 ml of
viscous yellow liquid in glass jar with printed label).

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals used were New Zealand albino rabbits, which were supplied
by Mission Laboratory Supply Company, Rosem ead, California.
They were approximately 2 1/2 to 3 1/2 months old (2 - 3 kg) at the
time of testing. A balanced Purina rabbit chow diet and water was fed
ad Libitum during the acclimation and testing periods. All test subjects
were quarantined and checked for signs of disease prior to testing.
All test animals were housed in stainless steel suspended cages.
The photoperiod was twelve (12) hours light and twelve (12) hours
darkness, and the ambient temperature was 70 - 72 degrees F.
The room in which the animals were housed received a minimum of
ten (10) complete air exchanges every hour.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of pure material

Duration of treatment / exposure:

4 h exposure period

Observation period:

4 h and 48 h

Number of animals:

6

Details on study design:

Testing was performed according to the above reference and is briefly summarized as follows :
Six (6) healthy young New Zealand rabbits were clipped free of hair dorsally and laterally on the trunk. The sample (0.5 ml ) was
then applied directly to the exposed skin of each animal and was covered with gauze squares which were securely taped and wrapped.
At the end of a four-hour exposure period, the bandages were removed and the sample was washed from the skin. Dermal reactions, erythema
eschar formation, edema, and necrosis were evaluated at 4 and 48 hours after exposure.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Irreversible Tissue Alteration

Basis:

mean

Time point:

other: 4

Score:

0.5

Max. score:

1

Reversibility:

other: 3 animals showed irreversible ulceration/necrosis of the tissue. 3 animals showed reversible changes.

Remarks on result:

other: 0=no permanent damage, 1=ulceration or necrosis

Results 2

Irritation parameter:

other: Irreversible Tissue Alteration

Basis:

mean

Time point:

other: 48 h

Score:

0.5

Max. score:

1

Reversibility:

other: 3 animals showed irreversible ulceration/necrosis of the tissue. 3 animals showed reversible changes.

Remarks on result:

other: 0=no permanent damage, 1=ulceration or necrosis

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 h

Score:

2.5

Max. score:

4

Reversibility:

other: See Irreversible Tissue Alteration section

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

2

Max. score:

4

Reversibility:

other: See Irreversible Tissue Alteration section

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 h

Score:

0.5

Max. score:

4

Reversibility:

other: see section Irreversible Tissue Alteration

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

4

Reversibility:

other: see section Irreversible Tissue Alteration

Irritant / corrosive response data:

Necrosis was observed in three animals and edema was present in two of these at the 4-hour reading. Of the other three animals, one had slight
erythema and one had well-defined erythema at the 4-hour reading.

Any other information on results incl. tables

6 animals were used in the study, exposure time 4 h.

Medium to high erythema was observed and low to medium edema was observed after 4 h exposure.

Treated area of 3 test animals recovered from the effect, for remaining 3 animals was observed permament damage of the tissue.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Boron, (benzenemethanamine)trifluoro-,(t-4)-, reaction products with bu glycidyl ether was found to be corrosive in study using BTP-3-3-055-81, Biological Corrosivity, (The Code of Federal Regulations, Title 49, Chapter 1, Section 173.1200, Appendix A) test method with rabbits.

Executive summary:

Corrosivity of Boron, (benzenemethanamine)trifluoro-,(t-4)-, reaction products with bu glycidyl ether was tested for corrosivity using BTP-3-3-055-81, Biological Corrosivity, (The Code of Federal Regulations, Title 49, Chapter 1, Section 173.1200, Appendix A) test method with rabbits. Medium to high erythema was observed and low to medium edema was observed after 4 h exposure. After 48 h was observed permanent tissue alteration in half of the test animals.