Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because no information regarding GLPs was provided; however, the study closely followed OECD 471 and EEC B.13/14.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because no information regarding GLPs was provided; however, the study closely followed OECD 471 and EEC B.13/14.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
reference to other study
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS: not reported

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Because 2-methylbutane was somewhat toxic at concentrations of 10% and above, additional tests were conducted at lower concentrations to determine mutagenicity.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

The results of the Ames test with the highest non-toxic dose are presented below. The positive control was mutagenic in strains TA98 and TA100, and was slightly mutagenic in strain TA1535. 2 -methylbutane was somewhat toxic at concentrations of 10% and above, so additional tests were conducted to determine whether the compound was mutagenic at lower concentrations (1, 2, 5, and 8%). Results show that 2 -methylbutane is not mutagenic at the lower concentrations.

Compound

Metabolic activation

Concentration of Gas in the Desiccator (V/V) %

Average histidine revertants per plate

 

 

 

TA1535

TA1537

TA1538

TA98

TA100

Negative control

-

 

15

12

10

29

138

 

+

 

16

18

30

38

155

Positive control (methylene chloride)

-

2

34

10

16

234

900

 

+

2

52

12

52

237

1066

2 -methylbutane

-

10

22

3

14

15

124

 

+

10

10

6

16

22

124

Conclusions:
Interpretation of results: negative

2-methylbutane was not found to be mutagenic at any concentration after evaluation via an Ames test.
Executive summary:

This data is being read across from the source study that tested 2-methylbutane based on analogue read across.

The genetic toxicity in bacteria of 2 -methylbutane was evaluated via an Ames test. 2 -methylbutane was not found to be mutagenic at any concentration in both the presence and absence of S9 mix. This study is classified as reliable with restrictions, Klimisch score 2, because information regarding GLPs was not provided. However, the study closely followed OECD 471 and EEC B.13/14. The standard plate test was modified due to the gaseous nature of the chemicals; these modifications did not affect the overall study results. One of the strains used (TA1538) is not included in the current Guidelines, and only data from the highest dose was presented in the study report. 

Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Ames test was modified for the gaseous chemical (did not affect results); strain TA1538 is not included in current Guidelines; only data from highest dose presented
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutane
EC Number:
201-142-8
EC Name:
2-methylbutane
Cas Number:
78-78-4
Molecular formula:
C5H12
IUPAC Name:
isopentane
Details on test material:
- Name of test material (as cited in study report): isopentane
- Substance type: C5 aliphatic
- Physical state: vapor
- Analytical purity: 97.2%
- Impurities (identity and concentrations): 2.8% n-pentane

Method

Target gene:
not reported
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine auxotrophs
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
other: histidine auxotrophs
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-stimulated S9 mix
Test concentrations with justification for top dose:
10% v/v
8% v/v
5% v/v
2% v/v
1% v/v
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: none
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: methylene chloride
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: not reported
- Exposure duration: 6 hours
- Selection time (if incubation with a selection agent): 40 to 45 hours

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: not reported

OTHER: The number of his+ revertants on each plate was counted and recorded.
Evaluation criteria:
The number of his+ revertants on each plate was counted and compared to the controls to determine mutagenicity.
Statistics:
not reported

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxic at concentrations of 10% and above
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS: not reported

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Because 2-methylbutane was somewhat toxic at concentrations of 10% and above, additional tests were conducted at lower concentrations to determine mutagenicity.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The results of the Ames test with the highest non-toxic dose are presented below. The positive control was mutagenic in strains TA98 and TA100, and was slightly mutagenic in strain TA1535. 2 -methylbutane was somewhat toxic at concentrations of 10% and above, so additional tests were conducted to determine whether the compound was mutagenic at lower concentrations (1, 2, 5, and 8%). Results show that 2 -methylbutane is not mutagenic at the lower concentrations.

Compound

Metabolic activation

Concentration of Gas in the Desiccator (V/V) %

Average histidine revertants per plate

 

 

 

TA1535

TA1537

TA1538

TA98

TA100

Negative control

-

 

15

12

10

29

138

 

+

 

16

18

30

38

155

Positive control (methylene chloride)

-

2

34

10

16

234

900

 

+

2

52

12

52

237

1066

2 -methylbutane

-

10

22

3

14

15

124

 

+

10

10

6

16

22

124

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative

2-methylbutane was not found to be mutagenic at any concentration after evaluation via an Ames test.
Executive summary:

The genetic toxicity in bacteria of 2 -methylbutane was evaluated via an Ames test. 2 -methylbutane was not found to be mutagenic at any concentration in both the presence and absence of S9 mix. This study is classified as reliable with restrictions, Klimisch score 2, because information regarding GLPs was not provided. However, the study closely followed OECD 471 and EEC B.13/14. The standard plate test was modified due to the gaseous nature of the chemicals; these modifications did not affect the overall study results. One of the strains used (TA1538) is not included in the current Guidelines, and only data from the highest dose was presented in the study report.