2-Propanamine, compd. with boron trifluoride, reaction products with Bu glycidyl ether

Endpoint summary

Description of key information

The test substance was tested in vivo on the skin of rabbits. Based on results the test material is corrosive to skin (Huntingdon Research, 1982).

The test substance was found to be corrosive in Corrositex study (MB Research, 2016).

Test material was found to be irritating to eyes in an in vivo study with rabbits (Huntingdon Research, 1977).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

The Corrositex® - InVitro International, Placentia, CA

Principles of method if other than guideline:

The Corrositex® (InVitro International, Placentia, CA) test is a standardized and reproducible method that can be employed to determine the potential corrosivity and the Packing Group classification of specified
categories of chemical compounds under the hazardous materials transportation regulations administered by the U.S. Department of Transportation (DOT) and international dangerous goods codes. The
Corrositex® test predicts1,2 the in vivo corrosive potential of a chemical compound or mixture by using as an endpoint the amount of time it takes for a chemical to permeate or destroy a synthetic biobarrier.
A color change in a proprietary liquid Chemical Detection System (CDS) is used to indicate that the chemical has passed through the biobarrier. This assay system is depicted below.

The Corrositex® test is a three step procedure. First, each test article was qualified to ensure that it was compatible with the Corrositex® system, and then it was categorized according to pH to determine cut-off
times. Finally, they were classified based on the mean time each test article took to penetrate the biobarriers.
Qualification
For each test article, 150 μl or 100 mg of the test article were added to the CDS reagent in a Qualify vial, and the vial was observed for any notable color change. An observable color change indicates that the
test article is compatible with the Corrositex® system.
Categorization
Next, each test article was categorized, which determined cut-off times for the Packing Group designations. A 10% formulation of each test article was prepared and its pH was measured. If the pH of the 10%
formulation was < 7.0, 150 μl or 100 mg of the neat test article were added to Tube A. The pH of Tube A was then measured, and if it was ≤ 5.0, the test article was assigned to Category 1, and if it was > 5.0, the
test article was assigned to Category 2. If the pH of the 10% formulation was > 7.0, 150 μl or 100 mg of the neat test article were added to Tube B. The pH of Tube B was measured, and if the final pH was ≥9.0, the
test article was Category 1, and if it was ≤ 9.0, the test article was Category 2.
Classification
Finally, each test article was classified by adding 500 μl or 500 mg of the test article to four test vials containing biobarriers to determine the Packing Group. If the test article mixture permeates or destroys
the biobarrier, it will come in contact with the CDS reagent in the vial and induce a color change similar to that observed in the Qualify tube. The amount of time required for the test article to permeate or destroy
each biobarrier was recorded and the mean time of the four replicates is used to designate the United Nations (U.N.) Packing Group classification. Classifications are as follows: Packing Group I (severe
corrosivity), Packing Group II (moderate corrosivity), Packing Group III (mild corrosivity), or Non-Corrosive. A positive control was performed using 1.0 N Sodium Hydroxide . The result for the Positive
Control is considered valid if it falls within the range of the MB Research historical mean ± 2 standard deviations. A negative control was performed using 1% citric acid; the result is considered valid if the
breakthrough time is greater than 60 minutes.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Anchor 1115, Lot# 1726820

Test system:

artificial membrane barrier model

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The crushed test article was used neat.

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

1

Value:

52.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

2

Value:

50.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

3

Value:

49.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

4

Value:

50.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Boron (2-propanamine) trifluoro-, rxn prod with butyl glycidyl ether was found to be corrosive in Corrositex study.

The test article was assigned to Category 2 test chemical determinded by the method's categorization test. The mean breakthrought time of the test article was >30 to 60 min and triggers thus the classification with Skin Corr. 1C.

Executive summary:

The pH of the 10% formulation of Boron (2-propanamine) trifluoro-, rxn prod with butyl glycidyl ether was 4.0 (i.e. <7.0) and the pH of Tube A was 7.0 (i.e. > 5.0). Consequently, the test article was assigned to Category 2 test chemical (determinded by the method's categorization test). The mean breakthrought time of the test article was >30 to 60 min and triggers thus the classification with Skin Corr. 1C.

Reference 2

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: Consumer Product Safety Commission of the USA in the Code of Federal Regulations, Title, 16, Section 1500.4 1.

Deviations:

yes

Remarks:

Due to the severity of the reactions three animals only were used.

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

not specified

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:

24 h exposure period

Observation period:

24 h and 72 h

Number of animals:

3

Details on study design:

Testing was performed according to the above reference and is briefly
summarized as follows :
3 rabbits were clipped free of hair. On one side of the animal was the skin abraded.
The sample (0.5 ml ) was then applied directly to the exposed skin and abraded skin of each animal and was covered with gauze squares which were securely taped and wrapped.
At the end of a 24-hour exposure period, the bandages were removed and the sample was washed from the skin.
Dermal reactions, erythema, edema, and necrosis were evaluated at 24 and 72 hours after exposure.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Abraded skin

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

3.7

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Abraded skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

3.3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Clipped skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 H

Score:

4

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Clipped skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Abraded skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

1.7

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Clipped skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

2.3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Abraded skin

Irritant / corrosive response data:

Severe "in deptht' skin damage with necrosis and small capillary hamorrhages was observed in all three animals at the 24 hours reading.
Similar reactions were seen at the 72 hours reading, although there was some reduction in the degree of oedema.

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Boron (2-propanamine) trifluoro-, rxn prod with butyl glycidyl ether was found to be corrosive in study using Consumer Product Safety Commission of the USA in the Code of Federal Regulations, Title, 16, Section 1500.4 1. test method with rabbits.

Executive summary:

Boron (2-propanamine) trifluoro-, rxn prod with butyl glycidyl etherwas tested for corrosivity using Consumer Product Safety Commission of the USA in the Code of Federal Regulations, Title, 16, Section 1500.4 1. test method with rabbits. Severe skin corrosion was observed in all three animals at the 24 hours reading. Similar reactions were seen at the 72 hours reading, although there was some reduction in the degree of oedema.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Justification for classification or non-classification

Based on the in vivo skin irritation test, the test substance has to be classified according to CLP regulation 1272/2008 as skin corrosive Cat 1 C.