1-aminopropan-2-ol

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Chemical Mutagenesis Testing in Drosophila. IX . Results of 50 Coded Compounds Tested for the National Toxicology Program

Author:

Foureman P, Mason JM, Valencia R, Zimmering S

Year:

1994

Bibliographic source:

Environmental and Molecular Mutagenesis 23(1):51-63

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster)

Version / remarks:

The guideline is not specified but given the scientific description of the study, performance similar to OECD 477 is suggested.

Principles of method if other than guideline:

Method: Woodruff, RC et al., Env. Mutagen., 6, 189-202.
Adult Canton-S males were subjected to a 3 day feeding exposure. They were mated to Basc females using a 2 to 3 day brooding pattern for a total of
three broods spanning 7 days. If the feeding sex-linked recessive lethal (SLRL) test was negative, an injection exposure was performed. As in the feeding exposure, a 2 to 3 day brooding pattern for three broods was used.

GLP compliance:

not specified

Type of assay:

Drosophila SLRL 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:

- Purity: 96.4 %
- Supplier: Aldrich (3803 LE)

Test animals

Species:

Drosophila melanogaster

Strain:

other: Canton S

Sex:

male

Administration / exposure

Route of administration:

other: In feed. If the results of the feeding SLRL test were negative, an injection exposure was performed.

Vehicle:

Water

Duration of treatment / exposure:

feeding study: 3 days; If the results of the feeding SLRL test were negative, a single injection exposure was performed.

Frequency of treatment:

continuously in feed

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

24 250 ppm

Remarks:

feeding study

Doses / concentrations 2

Dose / conc.:

1 940 ppm

Remarks:

injection

No. of animals per sex per dose:

no data

Control animals:

yes, concurrent no treatment

Examinations

Evaluation criteria:

A minimum of approximately 5,000 chromosomes were scored in each of the treated and concurrent control groups, unless the mutant frequency exceeded 1%. Clusters were identified using the Poisson distribution (Owen, 1962) and were removed before analysis.

Statistics:

The statistical evaluation of a SLRL test included a comparison with the concurrent solvent control using the normal approximation to the binomial distribution, as presented by Margolin et al. (1983), as well as a comparison with the historical control as described by Mason et al. (1992). In order to be considered mutagenic, the mutant frequency in the treated sample must exceed 0.15% with a P value of less than 0.05, or the treated frequency must exceed 0.1% with a P value of less than 0.01. If the treated frequency was between 0.1% and 0.15% and the P value was between 0.1 and 0.01; or if the treated frequency was higher than 0.15%, and the P value was between 0.1 and 0.05 the assay was considered equivocal. All other assays were considered negative.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

not specified

Any other information on results incl. tables

Table 1: Results of the drosophila testing in Mono-isopropanolamin.

Dose (ppm)	ROA	Percent mortality	Percent sterility	Lethals			Tests			Total lethals	Total tests	Percent lethals
				Br 1	Br 2	Br 3	Br 1	Br 2	Br 3
24,000	feeding	5	17	1	0	2	2,658	1,421	847	3	4,926	0.06
0				1	0	1	2,875	2,748	2,414	2	8,037	0.02
1,900	injection	14	8	2	2	2	1,911	1,675	1,562	6	5,148	0.12
0				0	2	0	1,739	1,493	1,079	2	4,311	0.05

One cluster of 3 in the injection control and one of 4 in the treated feeding experiment

Applicant's summary and conclusion

Conclusions:

Under the conditions tested the test substance was not mutagenic in a Drosophila SLRL assay.
Thus, MIPA is not considered to be genotoxic.