Catalyst 4S

Endpoint summary

Description of key information

Justification of the classification of the substance for eye irritation/corrosion

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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
see attached justification

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
see attached justification

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see attached justification

3. ANALOGUE APPROACH JUSTIFICATION
see attached justification

4. DATA MATRIX
see attached justification

Reason / purpose for cross-reference:

read-across source

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 80.2

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with the Regulation EC No. 1272/2008, the test item is considered as Non-irritant to skin.

Executive summary:

Based on the read across approach, the mean corrected percent viability of the treated tissues was 80.2%, versus 1.7% in the positive
control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008, the test item has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required

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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
see attached justification

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
see attached justification

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see attached justification

3. ANALOGUE APPROACH JUSTIFICATION
see attached justification

4. DATA MATRIX
see attached justification

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Value:

ca. 0.7

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: ICE class II

Irritation parameter:

fluorescein retention score

Value:

ca. 2

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: ICE class III

Irritation parameter:

percent corneal swelling

Value:

ca. 2

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: ICE class I

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: the combination of the 3 endpoints was 2xI, 1xII. Therefore, the negative control is classified as "No Category", as expected.
- Acceptance criteria met for positive control: the combination of the 3 endpoints was 3xIV. Therefore, the positive control is classified as "Corrosive/Severe irritant", as expected.

Interpretation of results:

study cannot be used for classification

Conclusions:

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category “no prediction can be made”, as defined by the OECD guideline No.438.
Therefore, the test item s not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method.

Executive summary:

Based on the read across approach, the results obtained under these experimental conditions lead to the category “no prediction can be made”, as defined by the OECD guideline No.438. Therefore, the test item is not predicted as causing serious eye damage (Category 1) or as not
classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Eye irritation

Based on the results obtained under the experimental protocol performed in accordance with the OECD 438 on an analogue substance, no prediction can be made.

The ocular reactions observed in the treated eyes show slight corneal damage with a score of 1 (out of 4), corresponding to the ICE Class II. The fluorescein retention also shows effects with a score of 2, corresponding to ICE class III.

Additional testing would be required to establish a definitive classification.

However, considering the knowledge gained of the dyes portfolio for which there is in vitro and in vivo data and the results of the OECD 438, the substance is expected to cause serious eye damage (Category 1), and is therefore classified as such, without the need for additional data.