Boron, (acetonitrile)trifluoro-, (T-4)-

Endpoint summary

Description of key information

In the key study (BASF, 2012) of skin corrosion, the test substance shows a corrosive potential in the Corrositex® test. No test was performed on eye irritation, as the complex is composed of boron trifluoride and acetonitrile and both substances are considered as corrosive to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

other: reconstituted collagen matrix

Strain:

other: not applicable

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Controls:

other: not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

up to 4 hours or until break through

Observation period:

Test substance: 3 min to 4 hours or until break through
Negative control: 60 min
Positive control: continuously until break through

Number of animals:

4 tests were performed for the test item, one test for the positive, negative and the blank control, respectively.

Details on study design:

The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). The Corrositex® assay is used to determine the corrosive potential of test substances. But the assay is limited to testing those materials which cause detectable pH changes in the CDS.
First, 150 μL of the test substance was added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required. In the main test, one vial was used for the PC, NC and for the color (blank) control, each. A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and approximately 500 μL of the test substance was added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS. If no color change was observed within three minutes, the remaining membranes were treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter the vials were observed for approximately ten minutes around the time points relevant for evaluation or until break through of the test substance occurred. The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier penetration) was recorded.

Break through time:

Substance	Break through time [min:s]				Mean [test item] break though time [min:s]
Test item	8:07	8:20	9:28	8:48	8:41
positive control	10:21
negative control	no break through

positive control: Sodium hydroxide, solid

negative control: 10% citric acid

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/Corrosion

In the key study (BASF, 2012) for skin corrosion, the test item was tested according to OECD no.435. The test item shows a corrosive potential in the Corrositex® test. In another study (Hilaski, R.J., 1997), the read across substance acetonitrile (CAS no. 75 -5 -8) was found to be non-irritating to the skin of rabbits (4 -hour exposure). All scores at each observation interval were 0.0 for each animal. No other signs of ill health or test article-related effects were observed during the study.

 

Eye irritation

No test with the complex was performed on eye irritation since boron trifluoride is classified as skin and eye corrosive. Clinical signs of respiratory distress were observed during short term and long term inhalation toxicity studies with the read across substances BF3 or BF3 dihydrate, even at low concentrations.

In the key study (OECD 405 equivalent, GLP, Hilaski, R.J., 1997), the read across substance acetronitrile (CAS no. 75-05 -8) was found to be severely irritating to the eyes of rabbits, with a maximum group average ocular Draize irritation score of 46.0 occurring at 24 hours postdose. Considerable ocular irritation was observed in all animals, including easily discernible corneal opacity, slight iris injection, diffuse beefy red conjunctivae, obvious swelling, partial lid eversion, and considerable discharge. Some ocular irritation was present in 4 of 6 animals at study termination 21 days after dosing. No other signs of ill health or toxicity were observed during the study.

Respiratory irritation

Taking the acute inhalation results of the read across substances (see IUCLID chapter 7.2.2) into account, it can be assumed that the test substance will lead to respiratory irritation when inhaled.

Justification for selection of eye irritation endpoint:
Waiver addresses corrosiveness to eyes of the substance.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Legal classification is available for both read across substances  boron trifluoride and acetonitrile: Dangerous Substance Directive (67/548/EEC), Table 3.1 List of harmonised classification and labelling of hazardous substances:
- boron trifluoride: C (R35: Causes severe burns)
- acetonitrile: Xi (R36: Irritating to eyes)
Classification, Labelling, and Packing Regulation (EC) No. 1272/2008, Table 3.1 List of harmonised classification and labelling of hazardous substances:
- boron trifluoride:  Skin Corr. 1A (H314: Causes severe skin burns and eye damage.)
- acetonitrile: Eye Irrit. 2  (H319: Causes serious eye irritation.) [Separate legal classification of boron trifluoride dihydrate (CAS 13319-75-0) is not available.]

Considering legal classification and study results, the complex of boron trifluoride with acetonitrile should be classified with respect to acute toxicity as follows:

Dangerous Substance Directive (67/548/EEC)

Based on the available data it the test item is considered to be classified as corrosive to eye and skin (C, R35 Causes severe burns) and irritant to the respiratory tract (R37 irritating to respiratory system) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC.

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

Based on the available data the test substance is considered to be classified for as corrosive to eye and skin (Skin Corr. 1A, H314 Causes severe skin burns and eye damage) and as irritant to the respiratory tract (H335 May cause respiratory irritation) under Regulation (EC) No. 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.