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

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

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)

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

600-775-0

Cas Number:

1067676-04-3

IUPAC Name:

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

Test material form:

liquid

Details on test material:

Technical grade, CA 50% in water

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

In vitro test system

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

Results and discussion

In vitro

Results

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

Applicant's summary and conclusion

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.