3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

May 26, 1983

Deviations:

no

Remarks:

no statistical analysis

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

EC Number:

407-920-5

EC Name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

Cas Number:

6390-69-8

Molecular formula:

C28 H42 O2

IUPAC Name:

3,3',5,5'-tetra-tert-butyl-[1,1'-biphenyl]-2,2'-diol

Details on test material:

- Name of test material (as cited in study report): generic name CA 16-178
- Analytical purity: 97.7% (not specified in the study [Lab. sample], transfered from 28d study [BASF SE [Ciba-Geigy Ltd/884619]], with same Lot/batch)
- Lot/batch No.: A 88103 / Z 1572R

Method

Target gene:

his-/trp- gene

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 1538 and TA 100; E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction of liver from rats (Tif:RAIf(SPF)) induced with Aroclor 1254

Test concentrations with justification for top dose:

- Toxicity test: 20, 39, 78, 156, 313, 625, 1250, 2500, and 5000 µg/plate (TA 100, without S9-mix)
- Main mutagenicity test: 5, 10, 50, 100, 500, 1000, and 5000 µg/plate; all strains, with and without S9-mix

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Without S9-mix (in µg/plate): 2-NF for TA98 and TA1538, 1&2µg; ENNG for TA100 & WP2 uvrA, 3&5/2&5 µg; SA for TA1535, 0.5&1µg; 9AA for TA1537, 40&80µg. With S9-mix: B(a)P for TA98, TA100, TA1537 and TA1538, 5&10 µg; 2-AA for TA1535/WP2uvrA, 2&4/40&80 µg

Remarks:

2-NF: 2-nitrofluorene; ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine; SA: sodium azide; 9AA: 9(5)-aminoacridine hydrochloride monohydrate; B(a)P: benzo(a)pyrene; 2-AA: 2-aminoanthracene (all but SA [H2O] dissolved in DMSO).

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours at 37°C


NUMBER OF REPLICATIONS: triplicates

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency

Evaluation criteria:

The test substance is considered to be positive in this test system if one or both of the following conditions are met:
(1) at least a reproducible doubling of the mean number of revertants per plate above that of the negative control at any concentration level for one or more of the tested strains;
(2) a reproducible increase of the mean number of revertants per plate for any concentration above that of the negative control by at least a factor of 1.5 for strain TA 100. Generally a concentration-related effect should be demonstrable.

Statistics:

None conducted

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 1538 and TA 100; E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

no marked deviation of the induced number of revertants per plate compared with the control values

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

a weak bacteriotoxic effect was observed from 156 µg/plate onwards

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 500 µg/plate and above the substance precipitated in soft agar

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Toxicity test in TA 100

Test concentration (µg/plate	Mean number of revertants/plate
0 (vehicle control)	160
20	168
39	136
78	133
156	125
313	109
625	124
1250	119
2500	114
5000	105
Positive control	1217

 

Table 2: Main first experiment

S9-mix	Test concentration (µg/plate)	Mean number of revertants (colonies/plate)
		Base-pair substitution type			Frameshift type
		TA 100	TA 1535	WP2 uvrA	TA 98	TA 1537	TA 1538
-	Vehicle control	108	9	17	19	6	7
	5	115	12	21	14	5	9
	10	144	21	27	21	6	7
	50	137	10	20	15	5	8
	100	122	11	20	15	6	8
	500	134	6	14	15	9	3
	1000	116	12	21	16	6	6
	5000	119	11	17	15	5	7
	Positive control	945	461	1291	260	241	497
+	Vehicle control	146	11	23	33	18	16
	5	150	10	25	29	16	15
	10	152	14	30	30	24	16
	50	165	11	29	30	14	11
	100	167	15	31	24	18	12
	500	137	9	26	15	15	26
	1000	125	8	24	24	15	12
	5000	132	11	20	24	16	15
	Positive control	502	138	688	433	138	198

 

Table 3: Main second experiment

S9-mix	Test concentration (µg/plate)	Mean number of revertants (colonies/plate)
		Base-pair substitution type			Frameshift type
		TA 100	TA 1535	WP2 uvrA	TA 98	TA 1537	TA 1538
-	Vehicle control	124	13	14	15	10	6
	5	122	9	12	12	11	4
	10	106	11	12	16	7	9
	50	113	12	13	11	8	7
	100	102	12	10	16	7	5
	500	124	9	12	14	10	8
	1000	117	9	10	15	7	5
	5000	97	14	12	17	11	4
	Positive control	759	413	798	206	323	315
+	Vehicle control	143	11	28	31	14	15
	5	145	12	30	26	15	18
	10	169	11	34	28	19	19
	50	150	10	27	30	16	18
	100	140	10	33	29	16	16
	500	153	16	38	27	17	13
	1000	150	11	38	35	15	20
	5000	158	11	23	32	20	18
	Positive control	419	168	449	399	136	193

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative