Chromium hydroxide sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2)

Justification for type of information:

The low pH in the range of 2 - 4 and indications of skin irritation suggest that classification is necessary.

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

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
Acetate salt is seen as an indicator for chromium salts with a moderate pH
Testing for sulphate is underway, but delatyed until April 2018

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