1-aminopropan-2-ol

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

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1987

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

Haworth S, Lawlor T, Mortelmans K, Speck W, Zeiger E (1983): Salmonella mutagenicity results for 250 chemicals. Environ Mutagen S[Suppl 1]:3-142.

Deviations:

yes

Remarks:

No E.coli strain or TA102 tested

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-aminopropan-2-ol

EC Number:

201-162-7

EC Name:

1-aminopropan-2-ol

Cas Number:

78-96-6

Molecular formula:

C3H9NO

IUPAC Name:

1-aminopropan-2-ol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Aldrich
- Purity: 96.4%

Method

Target gene:

Strain Target Gene:
TA1537 hisC3076
TA1535 hisG46
TA100 hisG46
TA98 hisD3052

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

The S9 fractions were prepared from the liver of Aroclor 1254-induced male Sprague-Dawley rats and male Syrian hamsters.

Test concentrations with justification for top dose:

33 - 4000 ug/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: For strains tested with S9: All strains, 2-aminoanthracene.

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

Evaluation criteria:

According to Haworth et al. (1983).

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA98, TA100, TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Slightly toxic at highest dose in the 3 strains.

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Slightly toxic at highest dose

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with

Genotoxicity:

ambiguous

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Slightly toxic at highest dose

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

Table 1-4: Results for the Ames-testing.

Strain TA100

Dose	No Activation (Negative)		10% HLI (Negative)		10% RLI (Negative)
Dose units	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	135	2	141	6.8	139	5.6
33	152	4	144	8.7	132	14.4
100	141	3.8	140	12.2	138	5.8
333	148	4.2	140	5.5	149	11.1
1000	155	0.9	128	6.4	124	4.3
3333	130S	7.8	159S	7	156S	6.5
Positive Control	1298	63.2	1452	83.5	947	33.3

Strain TA98

Dose	No Activation (Negative)		10% HLI (Negative)		10% RLI (Negative)
Dose units	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	18	2	30	0.6	24	1.2
33	19	2.6	36	1.5	25	4.4
100	25	2.9	43	1.9	30	6.3
333	17	2.3	25	2.1	33	0.7
1000	21	3.3	31	4.5	26	4.1
3333	8T	3.5	20S	4.3	20S	1.8
Positive Control	1475	103.9	935	33.9	637	42.8

Strain TA1537

Dose	No Activation (Negative)		10% HLI (Negative)		10% RLI (Negative)
Dose units	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	8	1.7	10	1.7	8	0.9
33	7	2.9	12	1.5	11	2.9
100	7	0.3	13	1.7	9	0.9
333	6	1.8	7	1.2	7	1
1000	6	0.6	7	1.3	8	0.3
3333	4S	1.2	4S	0.3	5S	0.3
Positive Control	87	12.3	124	6.1	97	2.9

Strain TA1535:

Dose	No Activation (Negative)		No Activation (Negative)		No Activation (Negative)		No Activation (Negative)		10% HLI (Equivocal)		10% HLI (Weak Positive)		10% HLI (Negative)		10% HLI (Positive)		10% RLI (Negative)		10% RLI (Positive)		10% RLI (Negative)		10% RLI (Positive)
Dose units	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	27	5	54	6.4	7	1.2	36	3.6	9	0.9	11	3.2	9	2.5	5	1	9	1.5	9	0.7	7	1.5	11	0
33	30	1.5							11	2.2							7	2.6
100	30	4.4	51	4.2	7	0.9	34	0.9	11	1	9	1	8	1.2	10	2.3	11	1.2	10	0.6	7	1.9	11	1.3
333	27	4.4	45	2.2	6	1.5	32	5	14	0.9	14	1.2	6	0.7	11	2	9	0.9	14	2.8	6	0.7	7	0.3
1000	20	1.5	47	3.8	4	0.7	23	4.8	10	1.2	9	0.3	7	1.3	11	4.2	7	1.8	14	0.7	5	1.5	9	0.7
1800			34	3.8	5	1.3	28	1.3			24	1.9	10	1.3	29	0.7			15	1.9	5	1.7	13	3.2
2800			25S	0.9	4S	1	23S	2			30S	2.9	5	0.6	28	6.6			33S	4.3	8	2	32	2.1
3333	12S	3.8	25S	4.5	4S	0.9	16S	3.2	27S	1.7	20S	1.8	8S	2.1	24S	2.7	17S	2.5	32S	2.6	6S	2.2	32S	2.2
3500			16S	0.6	3S	0.6	21S	0.3			18S	2.7	6S	1.5	25S	4.7			20S	1.5	6S	1	26S	2.2
4000			13S	1.7	2S	0.6	17S	2.1			21S	0.9	3S	0.3	15S	2.4			26S	5.1	4S	1.7	23S	3.3
Positive Control	1005	61	1484	111	869	23.8	1124	41.3	124	3.5	99	2.3	85	2.3	231	16.1	98	6.4	95	11.4	83	4.7	103	13.6

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; c = Contamination

Applicant's summary and conclusion

Conclusions:

Under the conditions tested the test substance was not mutagenic in the strains TA98, TA100 and TA1537.
However, with S9-activation the TA1535 strain presented some weak positive results. Therefore the test substance was rated as ambiguous.