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

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Performed to guidelines 2018 to GLP, but maximum tested treatment level below the expected maximum level, even though no toxicity and no precipitation.
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
The material was tested as supplied and instead of allowing for the 50% actives in water, the maximum treatment level of 5000 µg/plate relates to the material supplied and not adjusted to refelct the actives. There was an absence of any effects at a maximum treatment of 2500 µg/plate and it is not considered likely that this will have affected th eoutcome of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

Strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

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

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

Liver S-9 extract

Test concentrations with justification for top dose:

Eight concentrations of the 50% material as supplied 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate
This correspponds to a top dose of ca 2500 µg/plate and although lower then the recommended maximum concentration, the absence of any effects at any concentration would suggest that the material is not likely to be mutagenic in this assay.

Vehicle / solvent:

Water

Controls

Untreated negative controls:

yes

Remarks:

Untreated

Negative solvent / vehicle controls:

yes

Remarks:

Water

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

benzo(a)pyrene

other: 2-Aminoanthracene (2AA)

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 5

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The substance is supplied in solution at ca 50% actives and it not possible to isolate from water.
The material was tested as supplied and instead of allowing for the 50% actives in water, the maximum treatment level of 5000 µg/plate relates to the material supplied and not adjusted to refelct the actives. There was an absence of any effects at a maximum treatment of 2500 µg/plate and it is not considered likely that this will have affected th eoutcome of the study.