Piperidin-4-ol

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests: 111. Results from the Testing of 255 Chemicals

Author:

Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, Kristien Mortelmans, and William Speck

Year:

1987

Bibliographic source:

Environmental Mutagenesis Volume 9, Supplement 9:l-110,1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mention below

Principles of method if other than guideline:

To evaluate the mutagenic potential of 1,8-P-Menthanediaminc in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

p-menthane-1,8-diyldiamine

Cas Number:

80-52-4

Molecular formula:

C10H22N2

IUPAC Name:

p-menthane-1,8-diyldiamine

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: strains TA98, TA100, TA1535, and TA1537

Details on mammalian cell type (if applicable):

Not applicable.

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared. The S-9 mixes were prepared immediately prior to use and contained either 10% or 30% S-9.

Test concentrations with justification for top dose:

-S9;0,33-1000µg/plate
+S9: 10-1000 µg/plate

Vehicle / solvent:

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

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: -S9;sodium azide (TA1535 and TA l00), 9-aminoacridine (TA97 and TA 1S37), and 4-nitro-o-phenylenediamine (TA98). +S92-aminoanthracene for all strains.

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: Preincubation assay

DURATION
- Exposure duration: 48hour

Rationale for test conditions:

Not specified.

Evaluation criteria:

A chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it
produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials. A chemical was considered to be questionable (?) if a reproducible increase of hist revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his+ revertants in repeat trials.

Statistics:

Mean ± Standard deviation were observed.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA100, TA1535, and TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

Not specified.

Remarks on result:

other: No mutagenic effect were observed.

Any other information on results incl. tables

: 1,8-P-MENTHANEDIAMINE  (LAB: SRI     SOLVENT: DMSO)

DOSE	TA100						TA1535
	NA (-)		10% HLI (-)		10% RLI (-)		NA (-)		10% HLI (-)		10% RLI (-)
µg/PLATE	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM
0.000	107	11.3	98	7.0	109	7.8	26	1.0	10	1.2	10	1.7
10.000			116	9.2					10	3.7
33.000	126	1.2	109	9.4			35	2.7	9	1.8
100.000	118	10.6	99	5.1	102	5.9	30	5.8	11	1.5	8	0.9
333.000.	105	2.7	115	9.6	114	8.1	32	3.7	12	2.3	7	0.6
666.000	104	4.9					20	4.4
1000.000	73s	36.4	115	3.9	127	16.4	15s	3.5	12	1.5	10	2.0
1666.000					142	5.6					9	1.7
3333.000					99s	19.7					8s	0.6
POS	413	2.7	1072	24.5	359	4.2	481	11.8	416	15.9	162	11.0

 

 

 

 

 

 

 

 

 

 

DOSE	TA1537						TA98
	NA (-)		10% HLI (-)		10% RLI (-)		NA (-)		10% HLI (-)		10% RLI (-)
µg/PLATE	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM
0.000	4	1.5	5	0.3	6	0.6	16	0.7	23	3.2	29	1.0
10.000			6	1.7					20	3.8
33.000	7	1.8	6	1.2			17	0.9	25	2.6
100.000	3	0.6	5	0.9	7	1.5	17	1.5	23	3.4	26	0.9
333.000.	9	1.3	10	1.5	4	0.9	14	3.2	25	3.0	26	5.6
666.000	6	2.3					15	1.2
1000.000	3s	0.7	6	0.6	7	1.7	10s	3.0	27	0.3	24	6.2
1666.000					5	2.7					32	3.2
3333.000					5s	0.9					16s	0.7
POS	154	8.4	433	16.1	111	6.8	688	18.1	1308	39.0	333	13.9

Applicant's summary and conclusion

Conclusions:

1,8-P-Menthanediaminc (80-52-4)was evaluated for its mutagenic potential in Salmonella typhimurium TA98, TA100, TA1535, and TA1537. The test results were considered to be negative with and without S9.

Executive summary:

Genetic toxicity study for 1,8-P-Menthanediaminc was assessed for its mutagenic potential .For this purpose Bacterial reverse mutation assay was performed on Salmonella typhimurium TA98, TA100, TA1535, and TA1537.The test material was esposed at the concentration of 0,33-1000µg/plate in the absence of S9 while10-1000 µg/plate in the presence of S9.No mutagenic effect were observed. Therefore 1,8-P-Menthanediaminc was considered to be non mutagenic in Salmonella typhimurium TA98, TA100, TA1535, and TA1537 in the presence and absence of S9. Hence the substance cannot classify as gene mutant in vitro.