Reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride

Endpoint summary

Description of key information

The substance reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chlorides showed strong irritant effects in in vitro studies covering the endpoint skin irritation and eye irritation. As no follow-up studies regarding the endpoints skin corrosion and eye corrosion were performed, the substance is concluded as skin corrosive and eye corrosive in accordance with UN GHS Category 1.

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:

28.11. 2018 - 25.01.2019

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)

Version / remarks:

28 July 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: All cells used were purchased or derived from tissue obtained by MatTek Corporation from accredited institutions.

Source strain:

other: Keratinocyte Strain 267S3A

Justification for test system used:

This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg

Duration of treatment / exposure:

60 ± 1 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

6 (2 experiments with each 3 replicates)

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Experiment 1

Value:

48.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Experiment 2

Value:

38.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “skin irritant” in accordance with UN GHS “Category 2”. However, as no follow-up studies regarding the endpoint "skin corrosion" were performed, the test item is concluded as " skin corrosive" in accordance with UN GHS “Category 1”.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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

Study period:

29.11. - 13.12.2018

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)

Version / remarks:

25 Jun 2018

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

approx. 50 mg (83.3 mg/cm²)

Duration of treatment / exposure:

6 ± 0.25 h

Duration of post- treatment incubation (in vitro):

18 ± 0.25 h and 3 h ± 15 min

Irritation parameter:

other: relative tissue viability

Run / experiment:

Experiment 1

Value:

3.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “eye irritant” in accordance with UN GHS “Category 2”. However, as no follow-up studies regarding the endpoint "eye corrosion" were performed, the test item is concluded as " eye corrosive" in accordance with UN GHS “Category 1”.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chlorides showed strong irritant effects in in vitro studies covering the endpoint skin irritation and eye irritation. As no follow-up studies regarding the endpoints skin corrosion and eye corrosion were performed, the substance is concluded as skin corrosive and eye corrosive in accordance with UN GHS Category 1.