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Endpoint summary

Description of key information

In an in vitro membrane barrier test (CORROSITEX™ Assay), conducted according to OECD Test Guideline 435 and to GLP, Pt concentrate P was considered corrosive to the skin and classified as category 1B.

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 4133/00-K0
- Expiration date of the lot/batch: 07 June 2021
- Purity test date: Certificate of analysis dated 04 December 2020
- Form: liquid
- Appearance: Clear yellow liquid

Test system:

artificial membrane barrier model

Justification for test system used:

Recommended test system in international guideline (OECD 435).

Vehicle:

unchanged (no vehicle)

Details on test system:

Corrositex® is a test system that is composed of two components, a hydrated collagen matrix (bio-barrier) on a supporting filter membrane and CDS, an underlying aqueous solution of two pH indicator dyes.
The Corrositex® kit contained:
• Bio-barrier matrix.
• Bio-barrier diluent.
• Vials with Chemical Detection System (= CDS).
• Membrane discs.
• Compatibility test tubes.
• Timescale categorize test tubes with buffer A and B.
• Confirm reagent.
The batch number of the kit used for the experiment was CT080320.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µL
- Concentration (if solution): as is

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 500 µL
- Concentration (if solution): 10%

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 110 ± 15 mg (≥ 99%).

Duration of treatment / exposure:

The test system was observed until a reaction was detected

Number of replicates:

4

Irritation / corrosion parameter:

penetration time (in minutes)

Remarks:

mean penetration time

Run / experiment:

mean of 4 replicates

Value:

21.55

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: GSH 1B

Other effects / acceptance of results:

The test passed all acceptance criteria:
a) The negative control citric acid (10%) showed a mean penetration time of >60 minutes and was therefore non-corrosive.
b) The positive control sodium hydroxide (as it is) breakthrough time (18.51 minutes) falls within within ± two standard deviations of the positive control historical mean breakthrough time (Appendix 3).
c) The positive control sodium hydroxide (as it is) showed a mean penetration time of
18.51 minutes and was therefore classified as UN packing group II (=GSH 1B).
Overall it was concluded that the test system functioned properly.

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Pt concentrate P is classified as UN packing group II (= GHS 1B) in the Corrositex® assay under the experimental conditions described in this report.

Conclusions:

In an in vitro membrane barrier test (CORROSITEX™ Assay), conducted according to OECD Test Guideline 435 and to GLP, Pt concentrate P was considered corrosive to the skin.

Executive summary:

In a good quality GLP study, conducted according to OECD Test Guideline 435, the potential of Pt concentrate P to induce skin corrosion was assessed in the "in vitro membrane barrier test (CORROSITEX™ Assay)".

The test item was identified to be a timescale 2 test item and showed a mean penetration time of 21.51 minutes.

Pt concentrate P is therefore classified as "corrosive" to the skin (category 1B), according to EU CLP criteria (EC 1272/2008).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No relevant human irritation/corrosion data were identified.

 

In a good quality GLP study, conducted according to OECD Test Guideline 435, the potential of Pt concentrate P to induce skin corrosion was assessed in the "in vitro membrane barrier test (CORROSITEX™ Assay)". The test item was identified to be a timescale 2 test item and showed a mean penetration time of 21.51 minutes. Pt concentrate P is therefore classified as "corrosive" to the skin (category 1B), according to EU CLP criteria (EC 1272/2008).

 

No eye or respiratory tract data were identified. However, eye irritation testing is not considered appropriate as Pt concentrate P is classified as corrosive to the skin.

 

 

Justification for classification or non-classification

Based on the results of the available reliable in vitro skin corrosion study, Pt concentrate P should be classified as corrosive to the skin (category 1B) according to EU CLP criteria (EC 1272/2008). Substances that are corrosive to the skin are considered as leading to serious damage to the eyes. Consequently, Pt concentrate P should be classified for eye effects in Category 1 according to EU CLP criteria (EC 1272/2008).