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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 16 (Triethyl Phosphite), 2003 Paris.
Author:
OECD
Year:
2003
Bibliographic source:
UNEP Publications
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
(adopted 1983)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
(adopted 1997)
Deviations:
yes
Remarks:
Only 4 tester strains used. 2-Aminoanthracene was used as the sole positive control in the presence of S9-Mix.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethyl phosphite
EC Number:
204-552-5
EC Name:
Triethyl phosphite
Cas Number:
122-52-1
Molecular formula:
C6H15O3P
IUPAC Name:
triethyl phosphite
Details on test material:
Purity: 99.45%

Method

Target gene:
HIS operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9-mix from Aroclor 1254 induced rats.
Test concentrations with justification for top dose:
First test: 20, 100, 500, 2500, 12500 µg/plate.
Repeated test: 775, 1550, 3100, 6200, 12400 µg/plate.
Vehicle / solvent:
Dimethylformamide
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S-9: sodium azide (10 µg/plate), nitrofurantoin (0.2 µg/plate), 4-nitro-1,2-phenylene-diamine (10 µg/plate), with S-9: 2-aminoanthracene (3 µg/plate)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: no data
Evaluation criteria:
A reproducible and dose-related increase (i.e. greater than twice the negative control count) in mutant counts for at least one strain was considered a positive result.

Results and discussion

Test results
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:
>775 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
None of the tested strains showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls, both with and without the metabolic activation.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative