Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts

Endpoint summary

Description of key information

The substance appears only slightly irritating to skin (non-classified), but proved positive in a BCOP assay to be classified as Eye Dam 1

The substance is not possible to isolate from water and is manufactured and supplied as ca 50% actives. This mixture was used for testing and has been used for classification

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Guideline study in 2018 to GLP
Commercial grade material tested with ca 50% in water and solvents ethandiol and butanol
Not considered possible to isolate from water and solvents; the substance is stabilised by the presence of water under alkaline conditions

Qualifier:

equivalent or similar 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:

Commercial grade material tested with ca 50% in water and solvents ethandiol and butanol
Not considered possible to isolate from water and solvents; the substance is stabilised by the presence of water under alkaline conditions

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Applied as supplied at approximate 50% actives.
10 µl applied to the surface

Duration of treatment / exposure:

15 minutes period at 37 C

Number of replicates:

Three

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean of three assays

Value:

75.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

No other adverse effects reported

Interpretation of results:

GHS criteria not met

Conclusions:

The material failed to provoke sufficient response to be classified as CLP Skin Irrit 2, but the study is not validated to confirm if GHS Skin Irrit 3 would apply on not.
As the material ws tested as supplied as a ca 50% solution in water, it is accepted that if it was possible to isolate from water, then there is a chance that a pure material could lead to a stronger respnonse.
The substance is never isolated from solution.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Guideline study, 2018, to GLP
Commercial grade material tested with ca 50% in water and solvents ethandiol and butanol
Not considered possible to isolate from water and solvents; the substance is stabilised by the presence of water under alkaline conditions

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Commercial grade material tested with ca 50% in water and solvents ethandiol and butanol
Not considered possible to isolate from water and solvents; the substance is stabilised by the presence of water under alkaline conditions

Species:

cattle

Vehicle:

unchanged (no vehicle)

Controls:

yes

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.75 ml

Duration of treatment / exposure:

10 minutes exposure

Irritation parameter:

cornea opacity score

Run / experiment:

1

Value:

77.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

No other observations

Interpretation of results:

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

Conclusions:

Severe response, greater than the threshold for classification.
Study validation criteria were met.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)