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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Remarks:
Symrise
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Nerol
EC Number:
203-378-7
EC Name:
Nerol
Cas Number:
106-25-2
Molecular formula:
C10H18O
IUPAC Name:
3,7-dimethylocta-(Z)-2,6-dien-1-ol
Details on test material:
- Name of test material (as cited in study report): NEROL SUPRA
- Lot/batch No.: 50567952
- Physical state: colourless to pale yellowish liquid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 liver homogenate from Aroclor 1254 pretreated male rats
Test concentrations with justification for top dose:
- Prescreen: 5 - 5000 µg/plate
- Test: 5, 15, 50, 150, 500, 1500, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
without metabolic activation

Migrated to IUCLID6: 2.5 µg/plate (TA98) in DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
without metabolic activation

Migrated to IUCLID6: 0.7 µg/plate (TA100, TA1535) in water
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without metabolic activation

Migrated to IUCLID6: 50 µg/plate (TA1537) in water
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
without metabolic activation

Migrated to IUCLID6: 0.15 µg/plate (TA102) in water
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene, 0.8 µg/plate (TA98, TA100, TA102, TA1535), 1.7 µg/plate (TA1537) in DMSO
Remarks:
with metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 - 72 h, 37°C

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: reduction in revertant colonies or diminution of background lawn

Results and discussion

Test resultsopen allclose all
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:
Without S9, the test article was bacteriotoxic at 1500ug/plate. With S9, the test article was toxic to TA100 at 1500 ug/plate, and TA98, TA1535, and TA1537 at 5000ug/plate.
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Without S9, the test article was bacteriotoxic at 1500ug/plate. With S9, the test article was toxic at 1500 ug/plate
Vehicle controls validity:
not specified
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

5 - 5000 μg/plate: no effects

- At 5 ug/plate the test material did not induce any significant increase in the frequency of revertant mutations for strains TA102 with the S9 metabolizing system, and TA98, TA100, and TA102 without S9.

- Negative control plates with vehicle only gave counts of revertant colonies within the normal range.

- All strain specific positive controls, with and without S9, induced numbers of revertant colonies in the expected range.

- No precipitation of the test article was observed on the plates.

- At 15, 50, 150, and 500 ug/plate the test material did not induce any significant increase in the frequency of revertant mutations for strains TA98, TA100, TA102, TA1535, and TA1537 with or without the S9 metabolizing system.

1500 µg/plate:

- At 1500ug/plate the test material did not induce any significant increase in the frequency of revertant mutations for strains TA98, TA1535, and TA1537 with S9 metabolizing system.

- Negative control plates with vehicle only gave counts of revertant colonies within the normal range.

- All strain specific positive controls, with and without S9, induced numbers of revertant colonies in the expected range.

- In the absence of S9, the test article was bacteriotoxic to all strains.

- At this concentration in the presence of S9, the test article was bacteriotoxic to strain TA102 and TA100.

- No precipitation of the test article was observed on the plates

5000 μg/plate:

- The test article at this concentration was found to be bacteriotoxic to all strains of S. typhumurium with or without S9.

- Negative control plates with vehicle only gave counts of revertant colonies within the normal range.

- All strain specific positive controls, with and without S9, induced numbers of revertant colonies in the expected range.

- No precipitation of the test article was observed on the plates

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative