Chromium acetate

Endpoint summary

Description of key information

The susbtance is a weak acid and is only weakly irritating to eyes.

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

Study period:

60 minutes exposure with 42 hour post exposure incubation

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study to GLP

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 RGA16-5628

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

This in-vitro model is considered a suitable substitute for live animals

Vehicle:

unchanged (no vehicle)

Details on test system:

Test item - single application of nominal 25 mg on top of each tissue (tissues pre-wetted with 25μl PBS)
Reference items – single application 30 μl of negative control (PBS) or positive control (SDS 5%).
Three tissues were used per condition (n=3).

Control samples:

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

25 mg applied neat to wetted surface

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1

Value:

59

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The test item did not reduce the viability to 50% or below and should be considered as non-Irritant.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not reduce the viability to 50% or below and should be considered as non-Irritant.

Executive summary:

Valid study confirming that the criteria to classify as irritant were not met. However, there was some reduction in viability suggesting a weak irritation potential

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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 to GLP

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

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

ca. 4.4

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The low viability is close to figures seen for Eye Dam 1.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

It is noted that this method alone cannot validate the division between Eye Dam 1 and Eye Irrit 2, but acetates are weak acids and although the class if substance will show significant effect in this in-vitro assay, impact on the cornea (ie Eye Dam 1) is not expected.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

In-vitro testing indicates low level of irritation