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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
4 hour exposure
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study, performed to GLP 2017
Performed to confirm earlier in-vitro eye irritation result based on earlier RHCE assay.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (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 benzoate
EC Number:
209-042-6
EC Name:
Lithium benzoate
Cas Number:
553-54-8
Molecular formula:
C7H6O2.Li
IUPAC Name:
lithium benzoate
Specific details on test material used for the study:
Name Lithium benzoate
Batch no. 16B/02
Appearance white powder
Composition Lithium benzoate > 98%
Purity min. 98 %
Homogeneity homogeneous
Expiry date 09. Jun. 2019
Storage Room Temperature: (20 ± 5 °C); Keep away from humidity

Test animals / tissue source

Species:
cattle
Details on test animals or tissues and environmental conditions:
Bovine corneas were used. They were collected from slaughtered cattle which were be-tween 12 and 60 months old.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The test item Lithium benzoate was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.
Duration of treatment / exposure:
The test item was incubated on the cornea for 4 hours at 32 ± 1 °C.
Duration of post- treatment incubation (in vitro):
After removal of the test item, opacity and permeability values were measured.
Number of animals or in vitro replicates:
Three replicates

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Run / experiment:
1
Value:
> 140 - < 203
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 55 induces serious eye damage, that should be classified as UN GHS Category I.
Executive summary:

The test item was tested pure.

Under the conditions of this test, the test itemLithium benzoateinduced serious eye damage on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 163.61.

The negative control (HBSS-solution) 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.