Hydrogen peroxide-urea

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen peroxide-urea

EC Number:

204-701-4

EC Name:

Hydrogen peroxide-urea

Cas Number:

124-43-6

Molecular formula:

CH4N2O.H2O2

IUPAC Name:

carbamimidic acid; peroxol

Specific details on test material used for the study:

Test substance: Carbamide peroxide, i.e hydrogen peroxide - urea (1:1)
CAS number: 124.43-6
Purity: not staterd

Method

Target gene:

his operon

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 102

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

30% S9 from induced both rat and hamster liver

Test concentrations with justification for top dose:

according to guideline

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

not specified

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: positive without metabolic activation

Any other information on results incl. tables

Strain: TA100
Dose	No Activation (Negative)		No Activation (Negative)		No Activation (Weakly Positive)		30% RLI (Negative)		30% HLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM
0	131	3.8	177	7.8	164	.9	137	8.4	134	.6
10	166	6.1	217	17.6	172	11.3
33	145	8.7	181	4.5	211	5
100	162	9	149 s	8.5	267	3.2	138	9.5	144	7
150			105 s	19.8	248	10.4
200			100 s	21.9	165 s	11.1
333	66 s	5.8					149	3.5	141	5.7
1000	t						141	2	152	4.9
3333							147	6.1	162	6.3
10000							142	3.2	165	3.7
Positive Control	433	12.1	554	2.1	383	9	796	10.4	393	9.8

 

Strain: TA102
Dose	No Activation (Positive)		No Activation (Weakly Positive)		30% RLI (Negative)		30% HLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM
0	283	11.7	239	11.1	389	5.6	391	7.9
10			281	12.4
33	357	13.4	282	7.7
100	409	3.5	408	18.7	379	6.4	393	9.5
150			424	11.9
200	522	9.4	433	9.3
333	635	7.5			429	25.2	348	34.2
1000	789	15.7			430	14.8	396	9.5
3333					435	4.7	389	12.4
10000					441	8.6	424	7.7
Positive Control	1008	168.7	546	2.3	1254	215.7	2412	36.5

 

 

 

Strain: TA1535
Dose	No Activation (Negative)
Protocol	Preincubation
ug/Plate	Mean	±SEM
0	11	3.4
10	14	1.5
33	15	.7
100	15	2.6
150	11 s	3
200	9 s	.6
Positive Control	263	4

 

Strain: TA1538
Dose	No Activation (Negative)
Protocol	Preincubation
ug/Plate	Mean	±SEM
0	5	.3
10	3	.9
33	6	.9
100	6	1.5
150	6	1.5
200	3 s	0
Positive Control	292	9.9

 

Strain: TA98
Dose	No Activation (Equivocal)		No Activation (Equivocal)		No Activation (Positive)		No Activation (Weakly Positive)		30% RLI (Negative)		30% HLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM	Mean	±SEM
0	15	2.3	13	.3	17	2.2	25	3.8	23	1.2	19	1.5
10	18	.9	23	.9	20	3.4	30	4.5
33	17	3.8	20	3.5	24	0	38	3.5
100	26	1.2	42	4.4	35	2.6	50	6.7	20	1.5	23	1.5
150			25	3	52	2.6	27	7.3
200			13 s	1.2	37	6.7	4 s	1.2
333	6 s	1.9							27	3.3	25	1.8
1000	t								27	1.5	27	4
3333									19	1.5	25	1.8
10000									25	1.2	28	1.5
Positive Control	229	11	297	9.3	268	6.7	246	2	335	22.7	410	16

 

Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; t = Toxic;

 

Applicant's summary and conclusion

Conclusions:

Positive results were obtained in TA98 and TA102 in the absence of metabolic activation.

Executive summary:

Hydrogen peroxide-urea (1:1) (name in test report: carbamide peroxide) was tested in the AMES test using S. typhimurium strains TA98, TA100, TA102, TA1535, and TA1538 according to the OECD 471 test guideline both without and with metabolic activation (30% S9 supernatant from induced rat and hamster liver, respectively). Positive results were obtained in TA98 and TA102 in the absence of metabolic activation.

The study is considered to be fully reliable and suitable for assessment.