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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

- Ames test: negative (Principe P et al, 1981)
- two Ames tests (with two different concentrations: 0-166 µg/plate and 0-333 µg/plate): negative (NTP, 1995)

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed data
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not applicable
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
-
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 97, TA 98 and TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration: 0-333 µg/plate
Species / strain:
S. typhimurium, other: TA 1535, TA 97, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Conclusions:
Under the conditions employed in the assay described in this report, the data suggest that the test article allyl alcohol shows no genetic toxicity.

Interpretation of results: negative.
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed data
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not applicable
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
no data
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 97, TA 98 and TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration: 0-166 µg/plate
Species / strain:
S. typhimurium, other: TA 1535, TA 97, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Conclusions:
Under the conditions employed in the assay described in this report, the data suggest that the test article allyl alcohol shows no genetic toxicity.

Interpretation of results: negative.
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed journal
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not applicable
Principles of method if other than guideline:
The ability of 2-propen-1-ol (0.05 µl) to induce reversion in Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, TA100 was investigated using a spot test in the absence or presence of S9 (SD rat, Arochlor 1254 induction). The authors state that the system used was suitable for testing volatile substances. Ethyl methansulfonate (5 µl/plate; TA1535), 9-aminoacridine (10 µg/plate; TA1537), 4-nitro-o-phenyldiamine (10 µg/plate; TA1538 and TA98), ethyl methansulfonate (1 µl/plate; TA100) were used as positive control substances in the absence of S9. 2-Aminoanthracene (1 µg/plate) was used as positive control substance for all tester strains in the presence of S9.
PLATE INCORPORATION ASSAY
Mutagenic activity was also investigated in TA1535, TA100 and TA98 using a plate incorporation assay and 0.025, 0.05, 0.1 µl 2-propen-1-ol/plate in the absence or presence of S9. Comment: Concentrations in excess of 0.05 µl (= 50 nl; spot test) or 0.10 µl (= 100 nl; plate incorporation assay) were cytotoxic.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Target gene:
no data
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration: 0.025, 0.05, 0.10 µl/plate
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>0.10 µl/plate

The number of his+ revertants per plate was highly comparable in control and test cultures for all 5 tester strains both in the absence or presence of S9. A satisfactory response was obtained with the positive control substances.

PLATE INCORPORATION ASSAY

There was no increase in revertants in any of the 3 tester strains in the absence or presence of S9.

Conclusions:
Under the conditions of the test, 2-propen-1-ol (highest non-toxic concentration) was not mutagenic in a spot test (5 stains of Salmonella typhimurium including TA100 and TA1535) or a plate incorporation assay (3 tester strains).

Interpretation of results: negative.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

two Micronucleus tests (mouse: oral route; rat: intraperitoneal route): negative (NTP, 1995)

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed data
Qualifier:
according to
Guideline:
other: Standard NTP Protocol for in-vivo toxicology study
Deviations:
no
Principles of method if other than guideline:
The National Toxicology Program, USA (NTP) routinely conducts peripheral blood micronucleus tests on mice that are treated in the 13-week toxicity studies as part of the bioassay program. At the end of the 13-week exposure period (routes of exposure: inhalation, dosed-feed, drinking water, oral gavage, skin painting), a blood sample is obtained from male and female mice in each dose group (usually 10 animals per treatment group per sex) and slides are prepared, fixed and stained as for the bone marrow studies. Sample collection time is typically between 0 (in the case of continuous exposures) and 24 hours (in the case of single daily exposures). 1,000 to 10,000 mature erythrocytes (normochromatic erythrocytes or NCEs) are scored per animal for presence of micronuclei. These mature erythrocytes represent about 95% or more of the circulating erythrocytes. The percent PCE is determined in the blood as a measure of chemical-induced toxicity to the bone marrow. All data are analyzed separately for male and female mice.
The acridine orange staining procedure that is used for micronucleus slides allows the scorer to differentiate between the recently formed, immature erythrocytes (polychromatic or PCE) that are less than 48 hr old, and mature erythrocytes 2-35 days old (normochromatic or NCE) based on their staining characteristics. PCE contain residual RNA and thus they stain differently than the NCE that no longer have residual RNA. MN in PCEs arise from damage that occurred recently (within the past 48 hr) and the NCE population shows the result of damage accumulated over the past month, with the NCE population being in steady state equilibrium in the peripheral blood (newly damaged or undamaged erythrocytes are moving from bone marrow to blood at the same rate as old erythrocytes -- the NCEs-- are being removed from the blood). Thus, for longer-term peripheral blood MN studies, it is usually more appropriate to score MN in the NCE population. The mouse spleen is inefficient in removing damaged erythrocytes from circulation (thus permitting the achievement of steady state), but the rat spleen quickly eliminates micronucleated erythrocytes from circulation. Therefore, only mice can be used in a longer-term peripheral blood MN test that analyzes the NCE population. For acute studies, particularly those in which bone marrow tissue is analyzed, PCEs are scored.
GLP compliance:
not specified
Type of assay:
micronucleus assay
Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Route of administration:
oral: gavage
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
five times per week
Post exposure period:
10 to 14 days
No. of animals per sex per dose:
usually 10 animals per treatment group per sex
Tissues and cell types examined:
erythrocytes
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Positive controls validity:
valid
Conclusions:
Under the conditions employed in the assay described in this report, the data suggest that the test article allyl alcohol shows no genetic toxicity.

Interpretation of results: negative.
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: peer-reviewed data
Qualifier:
according to
Guideline:
other: Standard NTP Protocol for in-vivo toxicology study
Deviations:
no
Principles of method if other than guideline:
The National Toxicology Program, USA (NTP) routinely conducts peripheral blood micronucleus tests on mice that are treated in the 13-week toxicity studies as part of the bioassay program. At the end of the 13-week exposure period (routes of exposure: inhalation, dosed-feed, drinking water, oral gavage, skin painting), a blood sample is obtained from male and female mice in each dose group (usually 10 animals per treatment group per sex) and slides are prepared, fixed and stained as for the bone marrow studies. Sample collection time is typically between 0 (in the case of continuous exposures) and 24 hours (in the case of single daily exposures). 1,000 to 10,000 mature erythrocytes (normochromatic erythrocytes or NCEs) are scored per animal for presence of micronuclei. These mature erythrocytes represent about 95% or more of the circulating erythrocytes. The percent PCE is determined in the blood as a measure of chemical-induced toxicity to the bone marrow. All data are analyzed separately for male and female mice.
The acridine orange staining procedure that is used for micronucleus slides allows the scorer to differentiate between the recently formed, immature erythrocytes (polychromatic or PCE) that are less than 48 hr old, and mature erythrocytes 2-35 days old (normochromatic or NCE) based on their staining characteristics. PCE contain residual RNA and thus they stain differently than the NCE that no longer have residual RNA. MN in PCEs arise from damage that occurred recently (within the past 48 hr) and the NCE population shows the result of damage accumulated over the past month, with the NCE population being in steady state equilibrium in the peripheral blood (newly damaged or undamaged erythrocytes are moving from bone marrow to blood at the same rate as old erythrocytes -- the NCEs-- are being removed from the blood). Thus, for longer-term peripheral blood MN studies, it is usually more appropriate to score MN in the NCE population. The mouse spleen is inefficient in removing damaged erythrocytes from circulation (thus permitting the achievement of steady state), but the rat spleen quickly eliminates micronucleated erythrocytes from circulation. Therefore, only mice can be used in a longer-term peripheral blood MN test that analyzes the NCE population. For acute studies, particularly those in which bone marrow tissue is analyzed, PCEs are scored.
GLP compliance:
not specified
Type of assay:
micronucleus assay
Species:
rat
Strain:
Fischer 344
Sex:
male
Route of administration:
intraperitoneal
Duration of treatment / exposure:
72 Hours
Frequency of treatment:
five times per week
Post exposure period:
10 to 14 days
No. of animals per sex per dose:
usually 10 animals per treatment group per sex
Tissues and cell types examined:
erythrocytes
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Positive controls validity:
valid
Conclusions:
Under the conditions employed in the assay described in this report, the data suggest that the test article allyl alcohol shows no genetic toxicity.

Interpretation of results: negative.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

According to CLP classification criteria, the substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008.