Dipotassium 3,4,5,6-tetrabromophthalate

Eye irritation

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

Justification for type of information:

Guideline study performed 2020

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dipotassium 3,4,5,6-tetrabromophthalate

EC Number:

242-604-9

EC Name:

Dipotassium 3,4,5,6-tetrabromophthalate

Cas Number:

18824-74-3

Molecular formula:

C8H2Br4O4.2K

IUPAC Name:

Dipotassium 3,4,5,6-tetrabromophthalate

Test material form:

solid

Details on test material:

Dried, water-free

Specific details on test material used for the study:

Batch LP08112019
99% purity
White powder

Test animals / tissue source

Species:

human

Details on test animals or tissues and environmental conditions:

Stratified human keratinocytes

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

After pre-wetting tissues with 20µl Dulbecco’s Phosphate Buffered Saline for 30 minutes ± 2 minutes, a single, topical application of approximately 50mg of neat test item was applied to the surface of the EpiOcularTM model

Duration of treatment / exposure:

6 hours ± 15 minutes, followed by a 25 minutes ± 2 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation, prior to the MTT endpoint

Number of animals or in vitro replicates:

Three tissues per condition (n=3).

Results and discussion

In vitro

Results

Irritation parameter:

other: Viabiilty index

Run / experiment:

1

Value:

ca. 2.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

Viabilty range across three replicates prior to adjustment for colour control 2.5 - 3.4
No other observations

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Although the study performed was planned to assess the Eye Irrit 2 - Non-Classified boundary, the severity of the results suggest that Eye Dam 1 classification is appropriate.
For this assay, viablity of < 2% is a clear sign of Eye Dam 1 and normally, results in the 2 - 10% range are likely to be Eye Dam 1.

From expert assessment, Eye Dam 1 classification has been recommended.