Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
in vitro gene mutation study in bacteria
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:
guideline study without detailed documentation
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.14 (Ames-Test)
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix (S9 liver microsomal fraction induced with Phenobarbital and beta-Naphtoflavone)
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 31.6 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 31.6 ... 5000 μg/plate
Vehicle / solvent:
- Solvent used: DMSO (Dimethylsulfoxide)
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Additional information on results:
Observations
No toxic effecrs of the test item were observed in both experiments up to the highest investigated concentration in all strains used.

No substantial increases in the revertant colony numbers of any of the five test strains were detected at any dose level of the test item either with or without metabolic activation in both independently performed experiments.

As positive controls reference mutagens were tested in parallel to the test item. They showed a distinct increase of induced revertant colonies. Therefore, the validity and sensitvity of the test system was given.
Remarks on result:
other: Test system other: preliminary test
Conclusions:
In conclusion, the test item was negative with and without metabolic activation.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.14 (Ames-Test)
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
-
EC Number:
433-100-1
EC Name:
-
IUPAC Name:
Reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and lithium hydroxide

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix (S9 liver microsomal fraction induced with Phenobarbital and beta-Naphtoflavone)
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 31.6 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 31.6 ... 5000 μg/plate
Vehicle / solvent:
- Solvent used: DMSO (Dimethylsulfoxide)

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Additional information on results:
Observations
No toxic effecrs of the test item were observed in both experiments up to the highest investigated concentration in all strains used.

No substantial increases in the revertant colony numbers of any of the five test strains were detected at any dose level of the test item either with or without metabolic activation in both independently performed experiments.

As positive controls reference mutagens were tested in parallel to the test item. They showed a distinct increase of induced revertant colonies. Therefore, the validity and sensitvity of the test system was given.
Remarks on result:
other: Test system other: preliminary test

Applicant's summary and conclusion

Conclusions:
In conclusion, the test item was negative with and without metabolic activation.