Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2 has not been specifically tested for genetic toxicity, but there is test data on 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 (tested as CAS No 61791-44-4) which was tested in the Ames bacterial reverse mutation assay.  There is also data which can be used for read across for another structurally related substance with a very similar carbon chain length distribution, 2,2'(Octadec-9-enylimino)bisethanol CAS No 25307-17-9 which was tested in two additional in-vitro genotoxicty studies to current protocol and carried out to GLP with well-defined test substance.  Both these read across substances are more unsaturated and therefore more reactive than 2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2, so they are considered as a worst case for possible genetic toxicology.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
October 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No info on composition. Basic data given, according to guidelines/standards; incomplete reporting
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Remarks:
pre-GLP
Type of assay:
bacterial reverse mutation assay
Target gene:
Point mutations which involve substitution, addition or deletion of one or a few DNA base pairs
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
no info
Test concentrations with justification for top dose:
0, 0.2, 2, 20, 100 and 500 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not indicated but should be solubility
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-acetylaminofluorene (TA98, TA1538), 2-anthramine (TA100, TA1535), 8-aminoquinoline (TA1537)
Remarks:
with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-nitrofluorone (TA98 and TA1538), methylnitrosoguanidine (TA100, TA1535), quinacrine mustard (TA1537)
Remarks:
without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: no info

DURATION
- Preincubation period: no info
- Exposure duration: no info (date run was 4 Oct 1978; date read was 6 Oct 1978)

NUMBER OF REPLICATIONS:
3 plates per concentration and strain

DETERMINATION OF CYTOTOXICITY
- Method: observation of the bacterial background lawn for zones of inhibition

Evaluation criteria:
Two times or more the number of spontaneous revertant colonies was considered a positive response.
Statistics:
Not needed.
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
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Slight toxicity was seen at 500 and 100 ug dose levels in both activated and non-activated systems and at 20 ug in the non-
activated systen using test strains TA98, TA100, TA1535 and TA1537. No toxicity was seen at all levels using test strain TA1538.

CONTROL COUMPOUNDS:
The responses of teh control compounds were within the limits set for the test, indicating reliability.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

The test compound is not genotoxic in vitro in the Salmonella assay using test strains TA98, TA100, TA1535, TA1537, and TA1538. Test strains E. coli WP2 or TA102 were not used.
Executive summary:

Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 were treated with the test compound using the Ames test at 5 dose levels, in triplicate, both with and without metabolic activation. The dose range was determined in a prelimary toxicity assay and was 0.2 to 500 µg/plate. Levels of 20, 100 and 500 µg induced slight toxicity and were also used in the main test. The test was not repeated. The solvent DMSO control plates gave counts of revertant colonies within the normal range. All positive control chemicals produced marked increases in the number of revertant colonies, both with and without metabolic activation. The test compound caused no significant increase in the number of revertant colonies for any of the bacterial strains with or without metabolic activation. The test compound was found to be non-mutagenic under the conditions of this test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2, has not been specifically tested but there is test data on 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 which was tested in a bacterial reverse mutation assay (Ames) and was found not mutagenic with or without S9 mix. Also 2,2'(Octadec-9-enylimino)bisethanol CAS No 25307-17-9 a structurally similar substance was tested for mammalian cell gene mutation in the L5178Y TK +/- Mouse lymphoma assay and was not mutagenic.  In addition it was tested in a Chromosomal aberration test in human lymphocytes in-vitro and was found to be not clastogenic. All tests were to current OECD/EU protocols carried out to GLP and with a clearly defined and described test substance, which was tested in two additional in-vitro genotoxicty studies to current protocol and carried out to GLP with well-defined test substance. Both these read across substances are more unsaturated and therefore more reactive than 2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2, so they are considered as a worst case for possible genetic toxicology. Based on this it can be concluded that, 2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2 would not be expected to have any genotoxic hazard to human health. Based on this there are no requirements for in-vivo genotoxicity testing.

Justification for selection of genetic toxicity endpoint

2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2 has not been specifically tested for genetic toxicity, but there is test data on 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 (tested as CAS No 61791-44-4) which was tested in the Ames bacterial reverse mutation assay.  The read across substance is more unsaturated and therefore more reactive than 2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2, so it is considered as a worst case for possible genetic toxicology.

Justification for classification or non-classification

2,2’-(Octadecylimino)bisethanol CAS No 10213-78-2, has not been specifically tested but there is test data on two similar substances which are considered to be worst case for read across and very unlikely to underestimate any genotoxicity of this substance. All three in-vitro genotoxicity tests were consistently negative and therefore it is conclude that 2,2’-(Octadecylimino)bisethanol does not require classification as a mutagen according to the European Union CLP/GHS criteria. No in-vivo genotoxicty testing is required.