2-aminoethanol

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: Comparable to guideline study, no data on GLP, adequate for assessment

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity Test Data of Existing Chemical Substances, January 1996

Author:

JETOC

Year:

1996

Bibliographic source:

Japan Chemical Industry Ecology-Toxicology & Information Center, Japan

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Test guideline 2

Qualifier:

equivalent or similar to

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

This test has been held according to the Notification stipulating the standard provided by the Minister of Labour based on the Industrial Safety and Health Law Article 57-2 Paragraph 1 (Notification No.77 of the Ministry of Labour, dated September 1, 1988) and related Notice (No.603, dated September 16, 1988) .

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): 2-Aminoethanol
- Supplier: Tokyo Kasei Kogyo Co. Ltd.
- Analytical purity: extra pure reagent
- Lot. No. AQ01

Method

Target gene:

his

Species / strain

Species / strain 1

Species / strain / cell type:

other: TA98, TA 100, TA 102, TA 104, TA 1535, TA 1537 and TA1538

Species / strain 2

Species / strain / cell type:

other: WP2uvrA and WP2uvrA/pKM101

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9 (Sodium phenobarbital and 5,6-benzofravone-induced)

Test concentrations with justification for top dose:

50 - 5000 µg/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see below

Details on test system and experimental conditions:

The preincubation procedure was performed as described previously (Matsushima et al., 1980). The test compound dissolved in 0.05 or 0.1 ml of solvent was supplemented with 0.5 ml of S9 mix (metabolic activation method) or 0.1M phosphate buffer pH 7.4 (direct method) and 0.1 ml of tester strains which had been cultured in nutrient broth. The mixture was incubated for 20 min at 37°C, then rapidly mixed with 2 ml of molten top agar containing 0.05 µmol/ml of L-histidine and biotin for the Salmonella test. In the E. coli test 0.05 µmol/ml of L-tryptophan was used instead of L-histidine and biotin. Then the top agar mixture was rapidly poured onto a 30 ml of Vogel -Bonner minimal agar plate. All plates were incubated for 48 hours at 37°C and the numbers of revertant colonies were scored.

Evaluation criteria:

Two-hold rule criteria was used for data evaluation (Ames et al., 1975). The chemicals are considered to be mutagenic when a dose-related increase in revertant colony count is observed and the number of revertant colonies per plate with the test substance is more than twice that of the negative control (solvent control) and when a reproducibility of test result is observed. Mutagenic potency was calculated by following equation and maximum value of mutagenic potency was expressed as a specific acitivity on the data sheet: mutagenic potency (induced revertants / mg test substance) _(number of induced revertants on the dose X - number of revertant on the solvent control) = mg of test chemical on the dose X .

Results and discussion

Test results

Test results 1

Species / strain:

other: TA98, TA 100, TA 102, TA 104, TA 1535, TA 1537 and TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>=2000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

other: WP2uvrA and WP2uvrA/pKM101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>=2000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

control values (mean ± SD):

Tester strain	Solvent control		positive control
	- S9	+ S9	- S9	+ S9
TA100	138 ± 27	139 ± 29	728 ± 196	1011 ± 210
TA1535	14 ± 5	13 ± 4	300 ± 81	255 ± 70
TA98	20 ± 8	26 ± 7	413 ± 82	404 ± 118
TA1538 (2NF)	16 ± 3	23 ± 5	376 ± 79	556 ± 216
TA1538 (4NQO)	16 ± 3	23 ± 5	343 ± 34	556 ± 216
TA1537	8 ± 2	11 ± 4	497 ± 254	196 ± 70
TA102	260 ± 49	317 ± 52	758 ± 175	1676 ± 562
TA104	269 ± 40	332 ± 48	1973 ± 755	1196 ± 252
WP2uvrA	29 ± 11	34 ± 11	273 ± 126	879 ± 177
WP2uvrA/pKM101	141 ± 43	198 ± 49	2080 ± 884	928 ± 250

 

results with 2 -aminoethanol

conc (µg/plate)	Number of revertants/plete (mean of 2 Experiments)
	Base-substitution						Frame-shift
Strain	TA100		TA1535		WP2uvrA		TA98		TA1537		TA1539
Metabolic acitvation	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
pos control	942	462	258	172	274	1071	293	301	307	255	296	227
neg control	205	197	17	11	23	22	23	31	11	9	9	16
50	203	215	26	12	29	26	19	38	9	22	11	13
100	198	208	30	10	15	28	21	32	9	13	9	15
200	199	218	17	12	23	23	16	32	10	14	9	20
500	205	220	22	12	19	21	19	30	6	20	7	15
1000	188	191	15	19	26	26	22	28	6	17	8	8
2000	72	148	12	15	15	29	14	21	4	8	6	8
5000	0	0	0	0	0	0	0	0	0	0	0	0
Judgement	-	-	-	-	-	-	-	-	-	-	-	-

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative