Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test item was studied in the Bacterial Reverse Mutation Test following OECD Guideline 471 and EU Method B 13/14. Based on the results of theis study it is concluded that Bis(4-(1,1,3,3-tertramethyl butyl)phenyl)ether is not mutagenic in the Salmonella typhimurium Strains TA98, TA100, TA102, TA1535 and TA 1537 in the presence and absence of metabolic activation under experimental conditions in this study

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26. May 2020 -05. June 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
Type and composition of metabolic activation system:
S9 obtained from Trinova Biochem GmbH
Gießen,
Batch nos. 4180
produced from livers of mal Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight ingtraperitoneally
Test concentrations with justification for top dose:
Experiment 1: 5, 1.5, 0.5, 0.15, and 0.05 µl/plate,
Experiment 2: 5, 2.5, 1.25, 0.63, 0.31 and 0.16 µl/plate
Vehicle / solvent:
Acetone and DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
other: 4-Nitro-1,2-phenylene Diamine, 2-Amino-Anthracene
Details on test system and experimental conditions:
The test was performed in two experiments in the presence and absence of metabolic activation.
Rationale for test conditions:
according to OECD 471
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The results of this experiments showed that the test item caused no increase in the number of revertants in all bacterial strains compared to the solvent control, in both the pres-ence and absence of metabolic activation. The test item did not induce a dose-related increase in the number of revertant colonies in all strains, in the presence and absence of metabolic activation.
Remarks on result:
other: Based on the results of this study it is concluded that Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)ether is not mutagenic in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation.
Conclusions:
Based on the results of this study it is concluded that the test item is not mutagenic in the Bacterial Reverse Mutation Test following OECD Guideline 471 and EU Method B 13/14.
Executive summary:

The mutagenic potential of Bis(4-(1,1,3,3-tertramethyl butyl)phenyl)ether was studied in the Becterial Reverse Mutation Test following OECD Guideline 471 and EU Method B 13/14. The Salmonella typhimurium Strains TA98, TA100, TA102, TA1535 and TA 1537 did not show any mutagenic activity in the presence and absence of metabolic activation.

Therefore it is concluded that Bis(4-(1,1,3,3-tertramethyl butyl)phenyl)ether is not mutagenic under the experimental conditions in this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification