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

Endpoint summary

Description of key information

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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

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)

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.

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.

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 h

Score:

2.5

Max. score:

4

Reversibility:

other: See Irreversible Tissue Alteration section

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

2

Max. score:

4

Reversibility:

other: See Irreversible Tissue Alteration section

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 h

Score:

0.5

Max. score:

4

Reversibility:

other: see section Irreversible Tissue Alteration

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)