Dipotassium 3,4,5,6-tetrabromophthalate

Endpoint summary

Description of key information

The skin irritation study was positive and although viabilty was lower than the positive control sodium dodecyl sulphate, it was considered within the limits to conlude Skin Irrit 2

Although the Eye 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.

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:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study 2020

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch LP08112019
99% purity
White powder

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on animal used as source of test system:

Reconstructed human epidermal model

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

After pre-wetting tissues with 25µl Dulbecco’s Phosphate Buffered Saline a single, topical application of nominal 25mg neat test item to the surface of the EpiDermTM model

Duration of treatment / exposure:

60±1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% Relative Humidity (RH))

Duration of post-treatment incubation (if applicable):

42±4 hours post-treatment incubation, prior to the MTT endpoint

Number of replicates:

Three tissues per condition (n=3).

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1

Value:

ca. 6.4

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:

No other effects recorded

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Although viabilty was lower than the positive control sodium dodecyl sulphate, it was considered within the limits to conlude Skin Irrit 2

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

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

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)

Specific details on test material used for the study:

Batch LP08112019
99% purity
White powder

Species:

human

Details on test animals or tissues and environmental conditions:

Stratified human keratinocytes

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).

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)