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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
publication
Title:
Formaldehyde-induced mutations in Drosophila melanogaster in dependence of the presence of acids.
Author:
Stumm-Tegethoff BFA
Year:
1969
Bibliographic source:
Theor Appl Genetics 39, 330-334.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster)
Version / remarks:
Exceeds guideline study in that the effect of the pH value was clearly elucidated
GLP compliance:
no
Type of assay:
Drosophila SLRL assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium formate
EC Number:
205-488-0
EC Name:
Sodium formate
Cas Number:
141-53-7
Molecular formula:
CHO2Na
IUPAC Name:
sodium formate
Details on test material:
- Name of test materials (as cited in study report): Formic acid
Sodium formate; produced by neutralization of 0.1% formic acid with glycine-NaOH buffer (feeding experiment)
Specific details on test material used for the study:
- Name of test materials (as cited in study report): Formic acid
Sodium formate; produced by neutralization of 0.1% formic acid with glycine-NaOH buffer (feeding experiment)

Test animals

Species:
Drosophila melanogaster
Strain:
other: Oregon-K
Sex:
male

Administration / exposure

Route of administration:
oral: feed
Vehicle:
- Vehicle(s)/solvent(s) used: feed was used to allow dosing of both the liquid acid and the solid sodium formate salt
Duration of treatment / exposure:
entire larval stage
Doses / concentrations
Dose / conc.:
0.1 other: % as formic acid

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative

Any other information on results incl. tables


1) Vapor experiment
Exposure to 0.1% Formic Acid (FA) significantly (p<0.001) increased the  

number of mutations compared to controls.
=========================================================
                               Brood
           1st            2nd          3rd       total
---------------------------------------------------------
         n     %        n     %      n     %      n     % 
---------------------------------------------------------
FA     1068  1.12     1130  1.42    850  1.41   3048  1.31 

Historical control                              2584  0.15
=========================================================
n = number of chromosomes tested
% = percentage of sex-linked lethals found     
                                               

2) Larval feeding experiments
Exposure to 0.1% Formic Acid (FA) increased the number of mutations 

without gaining statistical significance between broods or compared to 

controls.
===========================================================
                               Brood
           1st            2nd          3rd       total
-----------------------------------------------------------
         n     %        n     %      n     %      n     % 
-----------------------------------------------------------
FA      786  1.15      522  1.34    671   0.88   1879  1.11
NaF                    544  0.38

Historical control                               2584  0.15
===========================================================
n = number of chromosomes tested
% = percentage of sex-linked lethals found 
NaF = Formic acid, neutralized to pH = 7.5 using a 0.1 M glycine-NaOH buffer.                                                  

The sodium formate (NaF; produced from formic acid by neutralization) sex-linked lethal was not different from the control. 

Formic acid results of the feeding study were also stated as not being significantly different from control.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

Formic acid was tested for genetic toxicity in a multigenerational test in Drosophila melanogaster similar to the OECD Guideline No. 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster). Following exposure to 0.1% formic acid vapour, the number of mutants was significantly increased compared to historical controls (p<0.001).  An increase was also seen with 0.1% formic acid in a subsequent feeding experiment, but without gaining statistical significance.  Sodium formate (produced by neutralization of formic acid) at the same molar concentration in the feed was negative in the Drosophila SLRL test. The authors concluded that the mutations observed with formic acid were related to the acidic pH, rather than to the acid or the formate molecule itself (Stumm-Tegethoff, 1969).

Conclusion:

Formic acid and sodium formate did not induce mutations in the Drosophila SLRL test in vivo.

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