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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium tetrafluoroborate, anhydrous
EC Number:
238-178-9
EC Name:
Lithium tetrafluoroborate, anhydrous
Cas Number:
14283-07-9
Molecular formula:
BF4.Li
IUPAC Name:
lithium tetrafluoroborate, anhydrous
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
cattle
Strain:
other: slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany
Details on test animals or tissues and environmental conditions:
The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour 20 minutes (exp. 1b) or 1 hour 5 minutes (exp. 1c).

Test system

Vehicle:
not specified
Amount / concentration applied:
750 µL
Duration of treatment / exposure:
4 hours at 32 ± 1 °C
Details on study design:
Open Chamber Method

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
1b
Value:
ca. 54.71
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Run / experiment:
1c
Value:
ca. 30.4
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made.
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
The test item Lithium Tetrafluoroborate showed effects on the cornea of the bovine eye. . The calculated IVIS was 54.71 in experiment 1b and 30.40 in experiment 1c.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this test,the test item Lithium Tetrafluoroborate showed effects on the cornea of the bovine eye. The calculated IVIS was 54.71 in experiment 1b and 30.40 in experiment 1c.

According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made.

The negative control (HBSS) and the positive control (20% imidazole solution) have met the validity criteria.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.