Bis(pentane-2,4-dionato-O,O')zinc

Endpoint summary

Description of key information

The relative mean viability of the test item treated tissues was 105.1 % after the 15-Minute exposure period.

The test item was considered to be Non-lrritant.

Thus a further test on skin corrosion is not deemed to be necessary.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Vehicle:

unchanged (no vehicle)

Remarks:

The epidermis surface had previously been moistened with 5 μI of sterile distilled water to improve contact between the solid test item and the epidermis.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

Triplicate tissues were treated with the test item

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean value

Value:

105.1

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

GHS criteria not met

Conclusions:

The relative mean viability of the test item treated tissues was 105.1 % after the 15-Minute exposure period.
The test item was considered to be Non-lrritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

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)

Details on test animals or tissues and environmental conditions:

Triplicate tissues were treated with 30 mg of the test item for 10 minutes. The tissues were dosed at regular timed intervals to allow for the period taken to rinse each insert following exposure and to ensure each tissue received an equal exposure time. The plates were incubated at 37°C, 5% C02 in air during the exposure time.

Vehicle:

water

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

30 mg of the test

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

The plates were incubated at 37°C, 5% C02 in air during the exposure time.

Number of animals or in vitro replicates:

3 replicates

Irritation parameter:

in vitro irritation score

Run / experiment:

The optical density was measured (quantitative measurement of tissue viability) at 540nm (00540)

Value:

1.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Assessment of Eye Irritation Potential - Viability of HCE Tissues

Item	Mean OD540	Relative Mean Viability (%)
Negative Control	0.785	100*
Positive Control	0.036	4.6
Test Item	0.011	1.4

* The mean viability of the negative control tissues is set at 100%.

The relative mean viability of the test item treated tissues after a 10-Minute exposure period was 1.4%.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on the study the test item was considered to be an lrritant.

Reference 2

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

Qualifier:

according to guideline

Guideline:

other: Isolated Rabbit Eye (in vitro)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Vehicle:

water

Controls:

yes, concurrent positive control

Amount / concentration applied:

0.1 of the test item

Duration of treatment / exposure:

240 minutes

Duration of post- treatment incubation (in vitro):

temperature of 32°C ± 1.5°C within the superfusion chamber

Number of animals or in vitro replicates:

three enucleated eyes

Irritation parameter:

other: Corneal Swelling

Run / experiment:

Corneal swelling in % after 240 mins

Value:

9.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

not applicable

Maximal ocular irritation observations recorded for the test eyes were as follows:

Corneal Opacity	Fluorescein Uptake	Corneal Swelling (%)						Condition of Corneal Epithelium
		Test eyes (3 eyes)			Control eyes (2 eyes)
0	0	11.3	11.2	9.1	10.4	8.1	5.1	normal

Interpretation of results:

GHS criteria not met

Conclusions:

Following assessment of the data for all endpoints the test item was considered unlikely to have the potential to cause severe ocular irritancy in vivo.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Two in vitro studies were performed on eye irritation.

While the result of the RhCE test would lead to a classification as irritating, the result of the IRE test suggests not to classify the substance.

Based on both test it is concluded that it is extremely unlikely that the substance is eye corrosive as none of the tests give an indication for that classification. Due to that the substance is classified as eye irritating.